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510(k) Final Decisions - June 2010

Posted Jul 06 2010 9:00pm
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD June 2010


DEVICE: TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL UNSCENTED TAMPONS, ULTRA
PROCTER & GAMBLE CO.              510(k) NO: K091281 (TRADITIONAL)
ATTN: KIMBERLY A NEMETH           PHONE NO : 513 634 3768   
6110 CENTER HILL AVE.             SE DECISION MADE: 01-JUN-10
CINCINNATI OH 45224               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XPERT MRSA/SA NASAL ASSAY
CEPHEID                           510(k) NO: K100822(TRADITIONAL)ATTN: RUSSEL K ENNS               PHONE NO : 408 400 8230   
904 CARIBBEAN DRIVE               SE DECISION MADE: 01-JUN-10
SUNNYVALE CA 94089 1189           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLYDESDALE SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK           510(k) NO: K100175 (TRADITIONAL)
ATTN: JUSTINE  VIERA              PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 02-JUN-10
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GEON RAPID DIGITAL THERMOMETER MODEL: MT-B117, MT-B127, MT-B130, MT-B132FA
GEON CORPORATION                  510(k) NO: K100563 (TRADITIONAL)
ATTN: JENNIFER  REICH             PHONE NO : 928 773 6340   
2904 N. BOLDT DRIVE               SE DECISION MADE: 02-JUN-10
FLAGSTAFF AZ 86001                510(k) STATEMENT

DEVICE: VIEWFLEX PLUS ICE CATHETER
ST. JUDE MEDICAL                  510(k) NO: K101239 (SPECIAL)
ATTN: LOUCINDA  BJORKLUND         PHONE NO : 651 756 3230   
ONE ST. JUDE MEDICAL DRIVE        SE DECISION MADE: 02-JUN-10
ST. PAUL MN 55117                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MALTA
3M ESPE AG DENTAL PRODUCTS        510(k) NO: K100756 (TRADITIONAL)
ATTN: DESI  SOEGIARTO             PHONE NO : 011 498 1527001169
ESPE PLATZ                        SE DECISION MADE: 02-JUN-10
SEEFELD, BAVARIA    GM D-82229    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYDROFIX SURGICAL SHEET
MIMEDX GROUP, INC                 510(k) NO: K100905 (SPECIAL)
ATTN: LOUISE  FOCHT               PHONE NO : 678 384 6720   
811 LIVINGSTON COURT SE SUITE B   SE DECISION MADE: 02-JUN-10
MARIETTA GA 30067                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100
PATHWAY MEDICAL TECHNOLOGIES, INC.510(k) NO: K101221 (SPECIAL)
ATTN: BRIAN  CLEARY               PHONE NO : 425 636 4079   
10801 120TH AVENUE NE             SE DECISION MADE: 02-JUN-10
KIRKLAND WA 98033                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTICARE DISPOSABLE PEN NEEDLES
ULTIMED, INC.                     510(k) NO: K100812 (TRADITIONAL)
ATTN: MARY BETH  HENDERSON        PHONE NO : 952 227 3380   
5353 WAYZATA BOULEVARD SUITE 505  SE DECISION MADE: 03-JUN-10
MINNEAPOLIS MN 55416 1334         510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MODIFICATION TO HBS HEADLESS BONE SCREW
BIOPRO, INC.                      510(k) NO: K101030 (SPECIAL)
ATTN: DAVID  MRAK                 PHONE NO : 810 982 7777   
2929 LAPEER ROAD                  SE DECISION MADE: 03-JUN-10
PORT HURON MI 48060               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AESKU PR3
AESKU.DIAGNOSTICS                 510(k) NO: K091859 (TRADITIONAL)
ATTN: SASCHA  PFEIFFER            PHONE NO : 49 673 496270
MIKROFORUM RING 2                 SE DECISION MADE: 03-JUN-10
WENDELSHEIM, RHEINLAND    GM D-552510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT
GENX INTL., INC.                  510(k) NO: K092667 (TRADITIONAL)
ATTN: MICHAEL D CECCHI            PHONE NO : 203 453 1700   
393 SOUNDVIEW RD.                 SE DECISION MADE: 03-JUN-10
GUILFORD CT 06437                 510(k) STATEMENT

DEVICE: AMBULATORY BLOOD PRESSURE MONITOR, MODELS FB-270 AND DS-270
NIHON SEIMITSU SOKKI CO., LTD.    510(k) NO: K093102(TRADITIONAL)ATTN: KOJI  KUBO                  PHONE NO : 81 42 5481253
3F, 2-17-6 AKEBONO-CHO            SE DECISION MADE: 03-JUN-10
TACHIKAWA- SHI, TOKYO    JA 190-00510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIODENTA DENTAL IMPLANT SYSTEM
BIODENTA SWISS AG                 510(k) NO: K093630 (TRADITIONAL)
ATTN: DAVID  EILER                PHONE NO : 417 174 71111
TRAMSTRASSE 16                    SE DECISION MADE: 03-JUN-10
BERNECK    SZ 9442                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYLE SMARTIP
OSSPRAY LTD                       510(k) NO: K100833 (TRADITIONAL)
ATTN: DAVID  GREENSPAN            PHONE NO : 352 283 0338   
3116 N.W. 62ND TERRACE            SE DECISION MADE: 03-JUN-10
GAINESVILLE FL 32606              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GRP HANDLE WITH HF-CONNECTOR AND INSTRUMENT ACCESSORIES
MGB ENDOSKOPISCHE GERATE GMBH (BER510(k) NO: K100564 (TRADITIONAL)
ATTN: PATRICK  GAENSICKE          PHONE NO : 
SCHWARZSCHILDSTRASSE 6            SE DECISION MADE: 03-JUN-10
BERLIN    GM D-12489              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD INTIMA II CLOSED IV CATHETER
BECTON DICKINSON INFUSION THERAPY 510(k) NO: K100775 (TRADITIONAL)
ATTN: LESLIE  WOOD                PHONE NO : 801 565 2533   
9450 SOUTH STATE ST.              SE DECISION MADE: 03-JUN-10
SANDY UT 84070                    510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CARECENTER MD
CARDIAC SCIENCE CORPORATION       510(k) NO: K093211 (TRADITIONAL)
ATTN: THERESA  MYERS              PHONE NO : 425 402 2365   
3303 MONTE VILLA PKWY.            SE DECISION MADE: 03-JUN-10
BOTHELL WA 98021                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020
COLOPLAST A/S                     510(k) NO: K101297 (SPECIAL)
ATTN: ANGELA  BYLAND              PHONE NO : 612 287 4236   
1601 WEST RIVER ROAD NORTH        SE DECISION MADE: 03-JUN-10
MINNEAPOLIS MN 55411              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HOTDOG MULTI FUNCTION CONTROLLER
AUGUSTINE BIOMEDICAL & DESIGN, LLC510(k) NO: K094056 (TRADITIONAL)
ATTN: JAMES  ECKLEIN              PHONE NO : 952 465 3500   
6581 CITY WEST PARKWAY            SE DECISION MADE: 03-JUN-10
EDEN PRAIRIE MN 55344             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: HANAROSTENT ESOPHAGUS (CCC)
M.I. TECH CO., LTD.               510(k) NO: K093537 (SPECIAL)
ATTN: BRANDON  CHOI               PHONE NO : 714 523 1592   
49 CANDLEWOOD WAY                 SE DECISION MADE: 04-JUN-10
BUENA PARK CA 90621               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES
NONIN MEDICAL, INC.               510(k) NO: K093853 (SPECIAL)
ATTN: LORI  ROTH                  PHONE NO : 763 577 3093   
13700 1ST AVE. NORTH              SE DECISION MADE: 04-JUN-10
PLYMOUTH MN 55441 5443            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIMPLER TOADSTOOL ABUTMENT, MODEL S19000-S19009
PAN GLOBAL IMPLANT                510(k) NO: K093975 (TRADITIONAL)
ATTN: HAROLD  BERGMAN             PHONE NO : 604 736 9890
#404, 1023 WOLFE AVE              SE DECISION MADE: 04-JUN-10
VANCOUVER, BC    CA V6H 1V6       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MIS SYSTEM
SPINE WAVE, INC.                  510(k) NO: K100605 (TRADITIONAL)
ATTN: DENISE  DUCHENE             PHONE NO : 203 712 1847   
THREE  ENTERPRISE DR. SUITE 210   SE DECISION MADE: 04-JUN-10
SHELTON CT 06484                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES
PIONEER SURGICAL TECHNOLOGY       510(k) NO: K100708 (TRADITIONAL)
ATTN: EMILY M DOWNS               PHONE NO : 906 225 5602   
375 RIVER PARK CIRCLE             SE DECISION MADE: 04-JUN-10
MARQUETTE MI 49855 0627           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SLEEPRIGHT
POWER PRODUCTS, INC.-SPLINTEK     510(k) NO: K100545 (TRADITIONAL)
ATTN: MELAINE  HASEK              PHONE NO : 913 410 2357   
9755 RIDGE DRIVE                  SE DECISION MADE: 04-JUN-10
LENEXA KS 66219                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORION II (HEAVY DUTY 350 LBS AND 500 LBS)
FUTURE MOBILITY HEALTHCARE INC.   510(k) NO: K101277 (SPECIAL)
ATTN: ABDULSAMAD  PANCHBHAYA      PHONE NO : 905 671 1661
3223 ORLANDO DRIVE                SE DECISION MADE: 04-JUN-10
MISSISSAUGA    CA L4V 1C5         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM
PHADIA US INC.                    510(k) NO: K091845 (TRADITIONAL)
ATTN: MARTIN ROBERT  MANN         PHONE NO : 269 492 1957   
4169 COMMERCIAL AVE.              SE DECISION MADE: 07-JUN-10
PORTAGE MI 49002                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PANPAC HSG CATHETER SET
PANPAC MEDICAL CORPORATION        510(k) NO: K092983(TRADITIONAL)ATTN: YEN-MING  PAN               PHONE NO : 886 286 472242
NO. 202, 6F-1.2, SEC.3 TATONG ROADSE DECISION MADE: 07-JUN-10
SHI-CHIH CITY, TAIPEI HSIEN    TW 510(k) STATEMENT

DEVICE: MODIFICATION TO SCINTRON IV
MIE GMBH                          510(k) NO: K101013 (SPECIAL)
ATTN: NORMAN  VON HOLLEN          PHONE NO : 847 981 6100   
420 BENNETT ROAD                  SE DECISION MADE: 07-JUN-10
ELK GROVE VILLAGE IL 60007        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FETAL MONITOR MODEL: BT-200T
BISTOS CO., LTD.                  510(k) NO: K100885 (TRADITIONAL)
ATTN: YOUNG  CHI                  PHONE NO : 973 278 5222   
111 ELLISON STREET                SE DECISION MADE: 07-JUN-10
PATERSON NJ 07505                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191
AMERICAN MEDICAL SYSTEMS, INC.    510(k) NO: K100807 (TRADITIONAL)
ATTN: DONNA  SEMLAK               PHONE NO : 952 930 6000   
10700 BREN RD., WEST              SE DECISION MADE: 07-JUN-10
MINNETONKA MN 55343               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY
SHANTOU I NSTITUTE OF ULTRASONIC I510(k) NO: K101008 (TRADITIONAL)
ATTN: BOB  LEIKER                 PHONE NO : 925 556 1302   
7263 CRONIN CIRCLE                SE DECISION MADE: 08-JUN-10
DUBLIN CA 94568                   510(k) STATEMENT

DEVICE: PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE
PATHWORK DIAGNOSTICS              510(k) NO: K092967 (TRADITIONAL)
ATTN: ANNA  LONGWELL              PHONE NO : 650 213 9162   
595 PENOBSCOT DRIVE               SE DECISION MADE: 08-JUN-10
REDWOOD CITY CA 94063             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LA GLOVE BRAND COLORED LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE (PINK/ GREEN/ VIOLET)
LA GLOVE (M) SDN. BHD.            510(k) NO: K093193 (TRADITIONAL)
ATTN: G  BASKARAN                 PHONE NO : 603 873 35411
LOT 478 JALAN SIMPANG BALAK, OFF BSE DECISION MADE: 08-JUN-10
KAJANG SELANGPR D.E.    MY 43000  510(k) STATEMENT

DEVICE: GUARDIVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 IN/ 4MM, STERILE, GUARD IVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 I
HEMCON MEDICAL TECHNOLOGIES EUROPE510(k) NO: K093729 (TRADITIONAL)
ATTN: KEVIN  HAWKINS              PHONE NO : 503 245 0459   
10575 SW CASCADE AVENUE SUITE 130 SE DECISION MADE: 08-JUN-10
PORTLAND OR 97223 4363            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30
MEDIANA CO., LTD.                 510(k) NO: K100217 (TRADITIONAL)
ATTN: CHARLIE  MACK               PHONE NO : 541 376 5063   
77325 JOYCE WAY                   SE DECISION MADE: 08-JUN-10
ECHO OR 97826                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200
HEALTHSTATS INTERNATIONAL PTE. LTD510(k) NO: K101002 (TRADITIONAL)
ATTN: STEPHEN  GORSKI             PHONE NO : 262 594 2114   
S65 W35739 PIPER ROAD             SE DECISION MADE: 08-JUN-10
EAGLE WI 53119                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THL1 LASER
ERCHONIA CORPORATION              510(k) NO: K100509 (TRADITIONAL)
ATTN: KEVIN  WALLS                PHONE NO : 720 962 5412   
5401 S. COTTONWOOD CT.            SE DECISION MADE: 08-JUN-10
GREENWOOD VILLAGE CO 80121        510(k) STATEMENT

DEVICE: VITAL SIGNS MONITOR-VSM 6000 SERIES
WELCH ALLYN, INC.                 510(k) NO: K101445 (ABBREVIATED)

ATTN: HY  DOAN                    PHONE NO : 315 685 3694   
4341 STATE ST. RD. P.O. BOX 220   SE DECISION MADE: 08-JUN-10
SKANEATELES FALLS NY 13153 0220   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE
EPOCAL, INC.                      510(k) NO: K093297 (TRADITIONAL)
ATTN: ROY  LAYER                  PHONE NO : 613 738 6192
2060 WALKLEY RD.                  SE DECISION MADE: 09-JUN-10
OTTAWA, ONTARIO    CA K1G-3P5     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUCTION IRRIGATION ELECTRODES AND ADAPTERS
ENCISION, INC.                    510(k) NO: K100711 (TRADITIONAL)
ATTN: JUDITH V KING               PHONE NO : 303 444 2600   
6797 WINCHESTER CIR.              SE DECISION MADE: 09-JUN-10
BOULDER CO 80301                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER)
ARKRAY FACTORY USA, INC.          510(k) NO: K093819 (TRADITIONAL)
ATTN: TOM  SPEIKERS               PHONE NO : 952 646 3168   
5182 WEST 76TH ST.                SE DECISION MADE: 09-JUN-10
MINNEAPOLIS MN 55439              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM
STANDARD DIAGNOSTICS, INC.        510(k) NO: K100398 (SPECIAL)
ATTN: SUSAN  GOLDSTEIN-FALK       PHONE NO : 949 706 7456   
55 NORTHERN BLVD., SUITE 200      SE DECISION MADE: 09-JUN-10
GREAT NECK NY 11021 1734          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM
AESCULAP IMPLANT SYSTEMS          510(k) NO: K100623 (TRADITIONAL)
ATTN: LISA M BOYLE                PHONE NO : 800 234 9179   
3773 CORPORATE PWKY.              SE DECISION MADE: 09-JUN-10
CENTER VALLEY PA 18034            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GRAFT DELIVERY SYSTEM MODEL SA-6115
MICROMEDICS, INC.                 510(k) NO: K100754 (TRADITIONAL)
ATTN: THOMAS A LOPAC              PHONE NO : 651 452 1977   
1270 EAGAN INDUSTRIAL ROAD        SE DECISION MADE: 09-JUN-10
ST PAUL MN 55121 1385             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MIRAGE MICRO MODEL 16333 (S), 16334 (M&L), 16335 (LW & XL)
RESMED LTD.                       510(k) NO: K100772 (SPECIAL)
ATTN: DAVID  D'CRUZ               PHONE NO : 858 836 5984   
9001 SPECTRUM CENTER BLVD.        SE DECISION MADE: 09-JUN-10
SAN DIEGO CA 92123                510(k) STATEMENT

DEVICE: BLOOD PRESSURE METER, MODEL CH-4532
CITIZEN SYSTEMS JAPAN CO., LTD.   510(k) NO: K093931 (SPECIAL)
ATTN: NATHAN A BEAVER             PHONE NO : 202 295 4039   
3000 K STREET NW SUITE 600        SE DECISION MADE: 10-JUN-10
WASHINGTON DC 20007 5143          510(k) STATEMENT

DEVICE: GUIDED GROWTH SYSTEM
ORTHOFIX INC.                     510(k) NO: K093442 (SPECIAL)
ATTN: MARY  BIGGERS               PHONE NO : 469 742 8834   
1720 BRAY CENTRAL DR.             SE DECISION MADE: 10-JUN-10
MCKINNEY TX 75069                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIBRO-TRAC
PNEUMEX, INC.                     510(k) NO: K092731 (TRADITIONAL)
ATTN: JEAN  ASQUITH               PHONE NO : 512 327 9997   
1705 S. CAPITAL OF TEXAS HWY SUITESE DECISION MADE: 10-JUN-10
AUSTIN TX 78746                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIDEKICK CIRCULAR FIXATOR SYSTEM: STRUTS AND HINGES
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K100137 (SPECIAL)
ATTN: MEGAN  MCCAGH               PHONE NO : 901 867 4120   
5677 AIRLINE RD.                  SE DECISION MADE: 10-JUN-10
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP, GILLINOV-COSGROVE SECTION GUIDE  MODEL VARIOUS LAA0
ATRICURE, INC.                    510(k) NO: K093679 (TRADITIONAL)
ATTN: JAMES  LUCKY                PHONE NO : 513 755 5754   
6217 CENTER PARK DRIVE            SE DECISION MADE: 10-JUN-10
WEST CHESTER OH 45069             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLEXI-LITE
PRESSURE-TECH, INC.               510(k) NO: K101262 (TRADITIONAL)
ATTN: MARIA  GRIFFIN              PHONE NO : 704 843 1675   
55 NORTHERN BLVD SUITE 200        SE DECISION MADE: 10-JUN-10
GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: RETRIEVE IMPLANT CEMENT
PARKELL, INC.                     510(k) NO: K101044 (TRADITIONAL)
ATTN: DANIEL R SCHECHTER          PHONE NO : 631 249 1134   
300 EXECUTIVE DR.                 SE DECISION MADE: 10-JUN-10
EDGEWOOD NY 11717                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM
MAQUET CARDIOVASCULAR, LLC        510(k) NO: K101274 (TRADITIONAL)
ATTN: MARK H SMITH                PHONE NO : 408 635 0630   
170 BAYTECH DRIVE                 SE DECISION MADE: 11-JUN-10
SAN JOSE CA 95134                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: BRAINLAB KNEE ARTHROSCOPY
BRAINLAB AG                       510(k) NO: K093118 (TRADITIONAL)
ATTN: RAINER  BIRKENBACH          PHONE NO : 498 999 15680
KAPELLENSTRASSE 12                SE DECISION MADE: 11-JUN-10
FELDKIRCHEN    GM 85622           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PASR/QUIETNITE
EXACT SUPPLIES LTD.               510(k) NO: K093340 (ABBREVIATED)

ATTN: JONATHAN  PARKINSON         PHONE NO : 440 798 0749941
THE STABLES,BRIGHTWELL BALDWIN    SE DECISION MADE: 11-JUN-10
WATLINGTON, OXFORDSHIRE    UK OX49510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X
AMBU A/S                          510(k) NO: K100129 (ABBREVIATED)

ATTN: SANJAY  PARIKH              PHONE NO : 410 768 6464   
6740 BAYMEADOW DR.                SE DECISION MADE: 11-JUN-10
GLEN BURNIE MD 21060              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE WATER LILY
CLEARWATER PRODUCTS, LLC          510(k) NO: K094022 (TRADITIONAL)
ATTN: E.J.  SMITH                 PHONE NO : 410 451 0639   
1468 HARWELL AVE.                 SE DECISION MADE: 11-JUN-10
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INRATIO/INRATIO2 TEST STRIPS
BIOSITE INCORPORATED              510(k) NO: K092987 (TRADITIONAL)
ATTN: KARIN A HUGES               PHONE NO : 858 805 3628   
9975 SUMMERS RIDGE RD             SE DECISION MADE: 11-JUN-10
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH
VITALTEC CORPORATION              510(k) NO: K100480 (TRADITIONAL)
ATTN: JEN  KE-MIN                 PHONE NO : 886 352 08829
NO. 58, FU CHIUN STREET           SE DECISION MADE: 11-JUN-10
HSIN CHU CITY    TW 30067         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GSP NEONATALGALT KIT, MODEL 3303-001U
PERKINELMER, INC.                 510(k) NO: K100101 (TRADITIONAL)
ATTN: KAY  TAYLOR                 PHONE NO : 317 418 1735   
8275 CARLOWAY ROAD                SE DECISION MADE: 11-JUN-10
INDIANAPOLIS IN 46236             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PREVENA INCISION MANAGEMENT SYSTEM
KCI USA, INC.                     510(k) NO: K100821 (TRADITIONAL)
ATTN: MARGARET  MARSH             PHONE NO : 210 255 6481   
6203 FARINON DR.                  SE DECISION MADE: 11-JUN-10
SAN ANTONIO TX 78249              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER
LABORATOIRES URGO                 510(k) NO: K100429 (SPECIAL)
ATTN: SOPHIE  FORTIN              PHONE NO : 003 338 0447967
42, RUE DE LONGVIC                SE DECISION MADE: 11-JUN-10
CHENOVE    FR 21300               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER
LABORATOIRES URGO                 510(k) NO: K100430 (SPECIAL)
ATTN: SOPHIE  FORTIN              PHONE NO : 003 338 0447967
42, RUE DE LONGVIC                SE DECISION MADE: 11-JUN-10
CHENOVE    FR 21300               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FIBER ONE
AMERICAN MEDICAL SYSTEMS          510(k) NO: K100746 (TRADITIONAL)
ATTN: DARLENE  CROCKETT-BILLIG    PHONE NO : 408 400 0856   
155-A MOFFETT PARK DRIVE SUITE 210SE DECISION MADE: 11-JUN-10
SUNNYVALE CA 94089                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: G-FORCE PEEK SUTURE ANCHOR SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K100630 (TRADITIONAL)
ATTN: KELLEN  HILLS               PHONE NO : 901 290 5816   
5677 AIRLINE RD.                  SE DECISION MADE: 11-JUN-10
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECSYS INSULIN CALCHECK 5
ROCHE DIAGNOSTICS CORP.           510(k) NO: K101075 (TRADITIONAL)
ATTN: SARAH  BAUMANN              PHONE NO : 317 521 3952   
9115 HAGUE RD. P.O. BOX 50410     SE DECISION MADE: 11-JUN-10
INDIANAPOLIS IN 46250 0416        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON
PATHWAY MEDICAL TECHNOLOGIES, INC.510(k) NO: K101334 (SPECIAL)
ATTN: CYNDY  ADAMS                PHONE NO : 425 636 4047   
10801 120TH AVENUE NE             SE DECISION MADE: 11-JUN-10
KIRKLAND WA 98033                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PATIENT MONITOR, MODEL PM50
CONTEC MEDICAL SYSTEM CO., LTD.   510(k) NO: K101127 (TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 862 164 264467
SUITE 8D , ZHONGXIN ZHONGSHAN MANSSE DECISION MADE: 11-JUN-10
ZHONG SHAN, SHANGHAI    CH 20030  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENSITE VELOCITY SYSTEM, MODEL EE3000
ST. JUDE MEDICAL                  510(k) NO: K101419 (SPECIAL)
ATTN: DONNA R LUNAK               PHONE NO : 651 756 2944   
ONE ST. JUDE MEDICAL DRIVE        SE DECISION MADE: 11-JUN-10
ST. PAUL MN 55117                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GENESIS DM MODEL: 6053000A1
HONEYWELL HOMMED, LLC             510(k) NO: K101242 (SPECIAL)
ATTN: EMILY  HEI                  PHONE NO : 262 252 6082   
3400 INTERTECH DR. SUITE 200      SE DECISION MADE: 11-JUN-10
BROOKFIELD WI 53045               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00
APOLLO ENDOSURGERY, INC.          510(k) NO: K082102 (TRADITIONAL)
ATTN: DENNIS  MCWILLIAMS          PHONE NO : 512 328 9990   
7000 BEE CAVES RD. SUITE 350      SE DECISION MADE: 14-JUN-10
AUSTIN TX 78746                   510(k) STATEMENT

DEVICE: MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B)
MINTA MEDICAL LIMITED             510(k) NO: K090608 (TRADITIONAL)
ATTN: ANDREW  EDWARDS             PHONE NO : 44 151 5486818
CADDICK ROAD                      SE DECISION MADE: 14-JUN-10
KNOWSLEY   MERSEYSIDE    UK L34 9H510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HALT 2000GI ELECTROSURGICAL RF ABLATION SYSTEM MODEL HALT 2000GI
HALT MEDICAL INC                  510(k) NO: K094009 (TRADITIONAL)
ATTN: RUSS  DELONZOR              PHONE NO : 925 934 7943   
131 SAND CREEK RD STE., B         SE DECISION MADE: 14-JUN-10
BRENTWOOD CA 94513                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORAL/ENTERAL SYRINGES
PHILIPS CHILDREN'S MEDICAL VENTURE510(k) NO: K100099 (TRADITIONAL)
ATTN: LISA  CASAVANT              PHONE NO : 724 244 2624   
191 WYNGATE DRIVE                 SE DECISION MADE: 14-JUN-10
MONROEVILLE PA 15146              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: SUDOSCAN
IMPETO MEDICAL                    510(k) NO: K100233 (TRADITIONAL)
ATTN: KYE  CHEUNG                 PHONE NO : 619 665 2796   
4479 SHOREPOINTS WAY              SE DECISION MADE: 14-JUN-10
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OTIS -C PLUS
SCIENCES ET BIO MATERIAUX (SBM)   510(k) NO: K100604 (TRADITIONAL)
ATTN: DENIS  CLEMENT              PHONE NO : 335 624 22101
ZI DU MONGE                       SE DECISION MADE: 14-JUN-10
LORDES    FR F 65100              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDICINA ENTERAL FEEDING TUBES AND ACCESSORIES MODEL MGX/YY
MAXTER CATHETERS                  510(k) NO: K100366 (TRADITIONAL)
ATTN: M. BERNARD  DAURELLE        PHONE NO : 330 491 467305
VILLAGE D'ENTREPRISES SAINT HENRI SE DECISION MADE: 14-JUN-10
MARSEILLE    FR 13016             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TIDI FACEMASK
TIDI PRODUCTS, LLC                510(k) NO: K100800 (TRADITIONAL)
ATTN: DION  BRANDT                PHONE NO : 920 751 4386   
570 ENTERPRISE DR.                SE DECISION MADE: 14-JUN-10
NEENAH WI 54956                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD DIRECTIGEN EZ FLU A+B ASSAY
BECTON DICKINSON & CO.            510(k) NO: K101529 (SPECIAL)
ATTN: GREGORY P PAYNE             PHONE NO : 858 795 7890   
11085 NORTH TORREY PINES RD SUITE SE DECISION MADE: 14-JUN-10
LA JOLLA CA 92037                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY
SURGICAL DEVICES, A GLOBAL BUSINES510(k) NO: K101444 (SPECIAL)
ATTN: FRANK  GIANELLI             PHONE NO : 203 492 5352   
60 MIDDLETOWN AVENUE              SE DECISION MADE: 14-JUN-10
NORTH HAVEN CT 06473              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: "UNITED STEM, PSA TYPE
UNITED ORTHOPEDIC CORP.           510(k) NO: K100981 (SPECIAL)
ATTN: FANG-YUAN  HO               PHONE NO : 886 357 73351
57 PARK AVE. 2, SCIENCE PARK      SE DECISION MADE: 14-JUN-10
HSINCHU    TW 300                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRYOCARE CS SURGICAL SYSTEM
ENDOCARE, INC.                    510(k) NO: K101333 (TRADITIONAL)
ATTN: DEVONNE  PAVLAK             PHONE NO : 949 450 5400   
9825 SPECTRUM DRIVE BLDG 2        SE DECISION MADE: 14-JUN-10
AUSTIN TX 78717                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG UNIVERSAL CHANNEL PLA510(k) NO: K101341 (TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 86 10 82387441
ROOM 1606 BLDG, 1 JIANXIANG YUAN NSE DECISION MADE: 14-JUN-10
BEIJING    CH 100083              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010
NIDACON INTERNATIONAL AB          510(k) NO: K092107 (TRADITIONAL)
ATTN: DANIEL  KAMM                PHONE NO : 847 374 8854   
333 MILFORD RD                    SE DECISION MADE: 15-JUN-10
DEERFIELD IL 60015                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23
ABBOTT DIABETES CARE INC.         510(k) NO: K092638 (TRADITIONAL)
ATTN: ARUL  STERLIN               PHONE NO : 510 864 4310   
1360 SOUTH LOOP RD.               SE DECISION MADE: 15-JUN-10
ALAMEDA CA 94502                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OUCHLESS MODEL PN10114
OCCAM DESIGN                      510(k) NO: K093951 (TRADITIONAL)
ATTN: VAS  ABRAMOV                PHONE NO : 502 315 3200   
1044 EAST CHESTNUT ST.            SE DECISION MADE: 15-JUN-10
LOUISVILLE KY 40204               510(k) STATEMENT

DEVICE: MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708; 851318704-708, 131218204
DEPUY ORTHOPAEDICS, INC.          510(k) NO: K101421 (SPECIAL)
ATTN: SUZANA  OTANO               PHONE NO : 305 269 6386   
700 ORTHOPAEDIC DR.               SE DECISION MADE: 15-JUN-10
WARSAW IN 46581 0988              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 10 X 10 VISION
BIOPTICS, INC.                    510(k) NO: K091928 (TRADITIONAL)
ATTN: AKIF  BAYSAL                PHONE NO : 520 399 8180   
3440 E BRITANNIA DR SUITE 150     SE DECISION MADE: 16-JUN-10
TUCSON AZ 85743                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POLYBONE DENTAL
KYUNGWON MEDICAL CO., LTD.        510(k) NO: K092194 (TRADITIONAL)
ATTN: JOYCE  BANG                 PHONE NO : 562 404 8466   
13340 EAST FIRESTONE BLVD. SUITE JSE DECISION MADE: 16-JUN-10
SANTA FE SPRINGS CA 90670         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COROENT XLR STANDALONE SYSTEM
NUVASIVE, INC.                    510(k) NO: K100043 (TRADITIONAL)
ATTN: SHEILA  BRUSCHI             PHONE NO : 858 320 4515   
7475 LUSK BLVD                    SE DECISION MADE: 16-JUN-10
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROBINSON MEDSURG QUICKSCREW RACK
ROBINSON MEDSURG LLC              510(k) NO: K093800 (TRADITIONAL)
ATTN: RANDOLPH C ROBINSON         PHONE NO : 303 706 1100   
7430 E. PARK MEADOWS DR. SUITE 300SE DECISION MADE: 16-JUN-10
LONE TREE CO 80124                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASCENSION ANKLE FUSION PLATE SYSTEM
ASCENSION ORTHOPEDICS, INC.       510(k) NO: K100176 (TRADITIONAL)
ATTN: DEBBIE  STEARNS             PHONE NO : 512 836 5001   
8700 CAMERON RD., STE. 100        SE DECISION MADE: 16-JUN-10
AUSTIN TX 78754 3832              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OXIBLUE FINGERTIP PULSE OXIMETER MODEL MD300C318, OXIPRO FINGERTIP PULSE OXIMETER MODEL MD300C316
OXYPULSE                          510(k) NO: K100815 (TRADITIONAL)
ATTN: JAMES A DUNNING             PHONE NO : 877 335 1702   
ONE MACDONAL CENTER 1 N. MACDONALDSE DECISION MADE: 16-JUN-10
MESA AZ 85201                     510(k) STATEMENT

DEVICE: CLEARPOINT SYSTEM
SURGIVISION, INC.                 510(k) NO: K100836 (TRADITIONAL)
ATTN: JOHN J SMITH M.D., J.D.     PHONE NO : 202 637 3638   
COLUMBIA SQUARE 555 THIRTEENTH ST,SE DECISION MADE: 16-JUN-10
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OLYMPIC BRAINZ MONITOR MODEL OBM70001
NATUS MEDICAL, INC.               510(k) NO: K093949 (TRADITIONAL)
ATTN: GOLDY  SINGH                PHONE NO : 905 829 5300
2568 BRISTOL CIRCLE               SE DECISION MADE: 16-JUN-10
OAKVILLE, ONTARIO    CA L6H 5S1   510(k) STATEMENT

DEVICE: CHEVEUX DIODE LASER SYSTEM
SANDSTONE MEDICAL TECHNOLOGIES, LL510(k) NO: K100893 (TRADITIONAL)
ATTN: MARK  ROHRER                PHONE NO : 205 290 8251   
105 CITATION COURT                SE DECISION MADE: 16-JUN-10
HOMEWOOD AL 35209                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COLLAWOUND ART
COLLAMATRIX, INC                  510(k) NO: K093351 (ABBREVIATED)

ATTN: DENNIS  J.N. SEAH           PHONE NO : 886 277 113299
26F, NO. 105, SECTION 2 DUNHUA SOUSE DECISION MADE: 16-JUN-10
TAIPEI    TW 106                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K101119 (TRADITIONAL)
ATTN: CHRISTINE  DUNBAR           PHONE NO : 925 602 8157   
4040 NELSON AVE.                  SE DECISION MADE: 16-JUN-10
CONCORD CA 94520                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNIMOM ALLEGRO
BLUE EGG CO                       510(k) NO: K100929 (TRADITIONAL)
ATTN: HONG J HYUN                 PHONE NO : 824 253 29226
216-5 YONGMOON-DONG, SEO-KU       SE DECISION MADE: 16-JUN-10
DAEJON, KOREA    KS               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ANGIOJET SOLENT PROXI THROMBECTOMY SET MODEL 109676-001
MEDRAD INTERVENTIONAL/POSSIS      510(k) NO: K101406 (SPECIAL)
ATTN: DOUG  ATKINS                PHONE NO : 763 780 4555   
9055 EVERGREEN BLVD NW            SE DECISION MADE: 16-JUN-10
MINNEAPOLIS MN 55433              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
HEBEI HANDFORM PLASTIC PRODUCTS CO510(k) NO: K101362 (TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 86 10 82387441
RM 1606 BLDG 1, JIANXIANG YUAN # 2SE DECISION MADE: 17-JUN-10
BEIJING    CH 100083              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: O-ARM IMAGING SYSTEM
MEDTRONIC NAVIGATION, INC. (LITTLE510(k) NO: K092564 (ABBREVIATED)

ATTN: SETH  KUZDZAL               PHONE NO : 978 698 6080   
300 FOSTER STREET                 SE DECISION MADE: 17-JUN-10
LITTLETON MA 01460                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPE
OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K093395 (TRADITIONAL)
ATTN: LAURA  STORMS-TYLER         PHONE NO : 484 896 5688   
3500 CORPORATE PARKWAY PO BOX 610 SE DECISION MADE: 17-JUN-10
CENTER VALLEY PA 18034 0610       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-23-10-E, EVO-FC-18-23-12-E
COOK IRELAND LTD                  510(k) NO: K093619 (TRADITIONAL)
ATTN: JACINTA  KILMARTIN          PHONE NO : 353 613 34440
O'HALLORAN ROAD NATIONAL TECHNOLOGSE DECISION MADE: 17-JUN-10
LIMERICK    EI                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HASKAL TORQUE DEVICE
ELCAM MEDICAL A.C.A.L.            510(k) NO: K100425 (TRADITIONAL)
ATTN: SHAY  SHAHAM                PHONE NO : 972 4 6988120
KIBBUTZ BAR-AM                    SE DECISION MADE: 17-JUN-10
MP. MEROM HAGALIL    IS 13860     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K093466 (TRADITIONAL)
ATTN: DOUGH  THISTLETHWAITE       PHONE NO : 330 425 1313   
1959 SUMMIT COMMERCE PARK         SE DECISION MADE: 17-JUN-10
TWINSBURG OH 44087                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE
PREVENTIVE TECHNOLOGIES, INC.     510(k) NO: K100539 (TRADITIONAL)
ATTN: KENNETH S PETERSON          PHONE NO : 704 849 2416   
4330 MATHEWS-INDIAN TRAIL ROAD    SE DECISION MADE: 17-JUN-10
INDIAN TRIAL NC 28079             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PATCHASSIST
POLYTOUCH MEDICAL LTD             510(k) NO: K101218 (TRADITIONAL)
ATTN: LEO  BASTA                  PHONE NO : 617 834 9866   
755 WESTMINSTER STREET UNIT 120   SE DECISION MADE: 17-JUN-10
PROVIDENCE RI 02903               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GYRUS ACMI HALO PKS CUTTING FORCEPS
GYRUS ACMI, INC.                  510(k) NO: K100896 (SPECIAL)
ATTN: LORRAINE  CALZETTA          PHONE NO : 508 804 2752   
136 TURNPIKE RD.                  SE DECISION MADE: 17-JUN-10
SOUTHBOROUGH MA 01772             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CIRCUFLOW 5200 SEQUENTIAL COMPRESSION DEVICE
DEVON MEDICAL INC.                510(k) NO: K101523 (TRADITIONAL)
ATTN: RUTH  WU                    PHONE NO : 800 251 7488   
1100 1ST AVENUE SUITE 100         SE DECISION MADE: 17-JUN-10
KING OF PRUSSIA PA 19406          510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: V-TRUST TD-8002 MULTI-PARAMETER SPOT-CHECK MONITOR MODEL TD-8002
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K101259 (TRADITIONAL)
ATTN: DEBRA  LIANG                PHONE NO : 886 266 258188
6F, NO. 127, WUGONG 2ND RD WUGU TOSE DECISION MADE: 17-JUN-10
TAIPEI COUNTY    TW 24888         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS
ANGIODYNAMICS, INC.               510(k) NO: K101017 (SPECIAL)
ATTN: S. MICHAEL  SHARP           PHONE NO : 518 798 1215   
603 QUEENSBURY AVE.               SE DECISION MADE: 17-JUN-10
QUEENSBURY NY 12804               510(k) STATEMENT

DEVICE: FIDUCIAL MARKERS
COSMAN MEDICAL, INC.              510(k) NO: K101131 (TRADITIONAL)
ATTN: LOUIS  FALCONE              PHONE NO : 781 272 6561   
76 CAMBRIDGE ST.                  SE DECISION MADE: 17-JUN-10
BURLINGTON MA 01803 4140          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100
OPTOVUE, INC.                     510(k) NO: K100861 (SPECIAL)
ATTN: AZIMUN  JAMAL               PHONE NO : 510 623 8868   
45531 NORTHPORT LOOP W.           SE DECISION MADE: 17-JUN-10
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COAXIAL INTRODUCER SET
MARTECH MEDICAL PRODUCTS          510(k) NO: K101399 (TRADITIONAL)
ATTN: SUSAN  PILEGGI              PHONE NO : 215 256 8833   
1500 DELP DR.                     SE DECISION MADE: 17-JUN-10
HARLEYSVILLE PA 19438 2900        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: T2 GREATER TROCHANTER NAIL
HOWMEDICA OSTEONICS CORP          510(k) NO: K101438 (SPECIAL)
ATTN: MELISSA  MATARESE           PHONE NO : 201 831 5116   
325 CORPORATE DR.                 SE DECISION MADE: 17-JUN-10
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LAGLOVE BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE (PINK COLOR)
LAGLOVE (M) SDN. BHD.             510(k) NO: K093335 (TRADITIONAL)
ATTN: G  BASKARAN                 PHONE NO : 603 873 35411
LOT 478, JALAN SIMPANG BALAK, OFF SE DECISION MADE: 18-JUN-10
KAJANG, SELANGOR, DARUL EHSAN    M510(k) STATEMENT

DEVICE: RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550
BIONIME CORPORATION               510(k) NO: K092052 (TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK      PHONE NO : 516 482 9001   
55 NORTHERN BLVD. SUITE 200       SE DECISION MADE: 18-JUN-10
GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE  PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48)
PULSION MEDICAL SYSTEMS AG        510(k) NO: K091786(TRADITIONAL)ATTN: JAMIE  SULLEY               PHONE NO : 919 562 4851   
7220 SPARHAWK RD.                 SE DECISION MADE: 18-JUN-10
WAKE FOREST NC 27587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NOVOTWIST NEEDLE, MODELS 30G  * 8MM (1/3") 32 G TIP * 5 MM(1/5')
NOVO NORDISK INC.                 510(k) NO: K093109 (TRADITIONAL)
ATTN: CINDY  CAO                  PHONE NO : 609 987 3914   
100 COLLEGE ROAD WEST             SE DECISION MADE: 18-JUN-10
PRINCETON NJ 08540 7810           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LASSO NAV CATHETER
BIOSENSE WEBSTER, INC.            510(k) NO: K093376 (TRADITIONAL)
ATTN: WAYNE  HOHMAN               PHONE NO : 909 839 8597   
3333 DIAMOND CANYON RD.           SE DECISION MADE: 18-JUN-10
DIAMOND BAR CA 91765              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710
APP PHARMACEUTICALS, LLC          510(k) NO: K092938 (TRADITIONAL)
ATTN: ARTHUR  WARD                PHONE NO : 813 645 2855   
962 ALLEGRO LN.                   SE DECISION MADE: 18-JUN-10
APOLLO BEACH FL 33572             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO
INSTRUMENTATION LABORATORY CO.    510(k) NO: K093623 (TRADITIONAL)
ATTN: CAROL  MARBLE               PHONE NO : 781 861 4467   
180 HARTWELL AVE.                 SE DECISION MADE: 18-JUN-10
BEDFORD MA 01730                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTIFUNCTIONAL LINEAR PEN
ATRICURE, INC.                    510(k) NO: K100501 (TRADITIONAL)
ATTN: JAMES  LUCKY                PHONE NO : 513 755 5754   
6217 CENTER PARK DRIVE            SE DECISION MADE: 18-JUN-10
WEST CHESTER OH 45069             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DRYODINE CADEXOMER-IODINE GEL
COLLEGIUM PHARMACEUTICAL INCORPORA510(k) NO: K093320 (TRADITIONAL)
ATTN: MARK W TRUMBORE             PHONE NO : 401 762 2000   
400 HIGHLAND CORPORATE DRIVE      SE DECISION MADE: 18-JUN-10
CUMBERLAND RI 02864               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PUMA MODEL VERSION 1.0
PROWESS, INC.                     510(k) NO: K100801 (TRADITIONAL)
ATTN: RACHEL  SCARANO             PHONE NO : 925 356 0360   
1844 CLAYTON ROAD                 SE DECISION MADE: 18-JUN-10
CONCORD CA 94520                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
ALPHATEC SPINE, INC.              510(k) NO: K100685 (SPECIAL)
ATTN: CHERYL  ALLEN               PHONE NO : 760 494 6770   
5818 EL CAMINO REAL               SE DECISION MADE: 18-JUN-10
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VAPR VUE RADIOFREQUENCY SYSTEM ,MODEL 225024, VPR VUE WIRELESS FOOTSWITCH, MODEL 227214
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K100638 (TRADITIONAL)
ATTN: SUSAN  KAGAN                PHONE NO : 508 880 8097   
325 PARAMOUNT DR.                 SE DECISION MADE: 18-JUN-10
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BF-NAVI
KGT INC.                          510(k) NO: K093810(TRADITIONAL)ATTN: RICHARD  VINCINS            PHONE NO : 512 327 9997   
1705 S. CAPITAL OF TEXAS HWY., SUISE DECISION MADE: 18-JUN-10
AUSTIN TX 78746                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MOTIVATION KNEE SYSTEM
ENCORE MEDICAL, L.P.              510(k) NO: K100900 (TRADITIONAL)
ATTN: ELIZABETH  ONDERLINDE       PHONE NO : 512 834 6302   
9800 METRIC BLVD.                 SE DECISION MADE: 18-JUN-10
AUSTIN TX 78758                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HALO ABLATION CATHETER MODEL 90-9100, HALO90 ULTRA ABLATION CATHETER MODEL 90-9200
BARRX MEDICAL INC                 510(k) NO: K101111 (SPECIAL)
ATTN: VIORICA  FILIMON            PHONE NO : 408 328 7302   
540 OAKMEAD PARKWAY               SE DECISION MADE: 18-JUN-10
SUNNYVALE CA 94085                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150
MORTARA INSTRUMENT, INC           510(k) NO: K101115 (ABBREVIATED)

ATTN: CHARLES  MORREALE           PHONE NO : 414 354 1600   
7865 NORTH 86TH STREET            SE DECISION MADE: 18-JUN-10
MILWAUKEE WI 53224                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTELLIVUE PATIENT MONITOR
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K101449 (SPECIAL)
ATTN: ANDREAS  SUCHI              PHONE NO : 49 703 14631291
HEWLETT-PACKARD STR.2             SE DECISION MADE: 18-JUN-10
BOEBLINGEN    GM 71034            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMPRESS ANTI-ROTATION SPINDLES
BIOMET MANUFACTURING CORP.        510(k) NO: K101475 (SPECIAL)
ATTN: PATRICIA  SANDBORN BERES    PHONE NO : 574 267 6639   
56 EAST BELL DRIVE P.O. BOX 587   SE DECISION MADE: 18-JUN-10
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012
GENERIC MEDICAL DEVICES, INC.     510(k) NO: K101440 (SPECIAL)
ATTN: JEFF  MORGAN                PHONE NO : 253 208 3430   
PO BOX 818                        SE DECISION MADE: 18-JUN-10
OCEAN SHORES WA 98569             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARTO XP EP NAVIGATION SYSTEM, VERSION 10
BIOSENSE WEBSTER, INC.            510(k) NO: K093566 (TRADITIONAL)
ATTN: WAYNE R HOHMAN              PHONE NO : 909 839 8597   
3333 DIAMOND CANYON RD.           SE DECISION MADE: 18-JUN-10
DIAMOND BAR CA 91765              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPUS SPEEDSCREW SYSTEM
ARTHROCARE CORP.                  510(k) NO: K101448 (SPECIAL)
ATTN: LAURA N KASPEROWICZ         PHONE NO : 
680 VAQUEROS AVE.                 SE DECISION MADE: 21-JUN-10
SUNNYVALE CA 94085 3523           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM)
N.M.B. MEDICAL APPLICATIONS, LTD. 510(k) NO: K100497 (SPECIAL)
ATTN: HILA  WACHSLER-AVRAHAMI     PHONE NO : 972 995 11511
11 HA'HOSHLIM STREET              SE DECISION MADE: 21-JUN-10
HERZELIYA    IS 46724             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FIAB SPA, MODELS F7244, F7233, F7234, F7277
FIAB SPA                          510(k) NO: K100333 (TRADITIONAL)
ATTN: FRANCESCO  BATISTINI        PHONE NO : 390 558 497914
VIA COSTOLI, 4                    SE DECISION MADE: 21-JUN-10
VICCHIO, FI    IT 50039           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OBSIDIAN CERAMIC BLOCKS
PRISMATIK DENTALCRAFT, INC.       510(k) NO: K100781 (ABBREVIATED)

ATTN: KEITH  ALLRED               PHONE NO : 949 440 2683   
4141 MACARTHUR BLVD               SE DECISION MADE: 21-JUN-10
NEWPORT BEACH CA 92660            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NON STICK BIPOLAR FORCEPS MODEL 07/XXX, BIPOLAR FORCEPS MODEL 08/XXX, MONOPOLAR FORCEPS MODEL 09/XXX
EGON FAULHABER SURGICAL INSTRUMENT510(k) NO: K101080 (TRADITIONAL)
ATTN: HARALD  JUNG                PHONE NO : 497 461 969236
UNTERER WINKEL 3                  SE DECISION MADE: 21-JUN-10
WURMLINGEN    GM D-78573          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANTI-HAV IGM
ROCHE DIAGNOSTICS                 510(k) NO: K093955 (TRADITIONAL)
ATTN: KELLY  FRENCH               PHONE NO : 317 521 3208   
9115 HAGUE ROAD                   SE DECISION MADE: 22-JUN-10
INDIANAPOLIS IN 46250             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRYKER BIPOLAR FORCEPS
STRYKER LEIBINGER GMBH & CO. KG   510(k) NO: K093108 (TRADITIONAL)
ATTN: ROB  YAMASHITA              PHONE NO : 269 323 4258   
750 TRADE CENTRE WAY SUITE 200    SE DECISION MADE: 22-JUN-10
PORTAGE MI 49002                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVES
QUALITY GALLANT SDN. BHD.         510(k) NO: K092874 (TRADITIONAL)
ATTN: TERENCE  READ               PHONE NO : 605 849 4931
LOT 1874, JALAN KAMPUNG DEW SIMPANSE DECISION MADE: 22-JUN-10
TAIPING, PERAK    MY 34700        510(k) STATEMENT

DEVICE: PHILIPS AVENT DIGITAL THERMOMETER SET, MODEL SCH540
PHILIPS ELECTRONICS UK LIMITED    510(k) NO: K100495 (TRADITIONAL)
ATTN: MIRIAM  SHARIF-MURRAY       PHONE NO : 630 396 0510
LOWER ROAD                        SE DECISION MADE: 22-JUN-10
GLEMSFORD, SUFFOLK    UK CO10 7QS 510(k) STATEMENT

DEVICE: ZQUIET MOUTHPIECE
SLEEPING WELL, LLC                510(k) NO: K093407 (TRADITIONAL)
ATTN: YOLANDA  SMITH              PHONE NO : 888 978 3013   
1468 HARWELL AVE.                 SE DECISION MADE: 22-JUN-10
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TINA-QUANT FERRITIN GEN. 4
ROCHE DIAGNOSTICS                 510(k) NO: K100538 (TRADITIONAL)
ATTN: KATHIE J GOODWIN            PHONE NO : 317 521 3831   
9115 HAGUE ROAD PO BOX 50416      SE DECISION MADE: 22-JUN-10
INDIANAPOLIS IN 46250             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AFFIITY CP CENTRIFUGAL BLOOD PUMP
MEDTRONIC INC.                    510(k) NO: K100631 (TRADITIONAL)
ATTN: SUE  FIDLER                 PHONE NO : 763 514 9839   
7611 NORTHLAND DRIVE              SE DECISION MADE: 22-JUN-10
MINNEAPOLIS MN 55428              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12
BIOSENSE WEBSTER, INC.            510(k) NO: K101138 (SPECIAL)
ATTN: MELISSA C SCHULTZ, RAC, MMS PHONE NO : 909 839 8787   
3333 DIAMOND CANYON RD.           SE DECISION MADE: 22-JUN-10
DIAMOND BAR CA 91765              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04,
BIOSENSE WEBSTER, INC.            510(k) NO: K101345 (TRADITIONAL)
ATTN: BALAKA  DAS                 PHONE NO : 909 839 8599   
3333 DIAMOND CANYON RD.           SE DECISION MADE: 22-JUN-10
DIAMOND BAR CA 91765              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL
CENTERS FOR DISEASE CONTROL AND PR510(k) NO: K101564 (TRADITIONAL)
ATTN: HYE-JOO  KIM                PHONE NO : 404 639 4643   
1600 CLIFTON RD., N.E. MAILSTOP C-SE DECISION MADE: 22-JUN-10
ATLANTA GA 30333                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVE
HONGZE PLASTIC TECHNOLOGY CO., LTD510(k) NO: K101137 (TRADITIONAL)
ATTN: KATHY  LIU                  PHONE NO : 909 287 0357   
1930 BREA CANYON RD               SE DECISION MADE: 22-JUN-10
DIAMOND BAR CA 91765              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K101074 (TRADITIONAL)
ATTN: SARAH  FAIRFIELD            PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 22-JUN-10
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD
OMNI LIFE SCIENCE, INC.           510(k) NO: K101451 (SPECIAL)
ATTN: RADHIKA  PONDICHERRY        PHONE NO : 774 226 1852   
50 O'CONNELL WAY                  SE DECISION MADE: 22-JUN-10
EAST TAUNTON MA 02718             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MLS-AC DERMA SCANNER
ERCHONIA CORPORATION              510(k) NO: K101430 (TRADITIONAL)
ATTN: KEVIN  WALLS                PHONE NO : 720 962 5412   
5401 S. COTTONWOOD CT.            SE DECISION MADE: 22-JUN-10
GREENWOOD VILLAGE CO 80121        510(k) STATEMENT

DEVICE: DUAL LUER LOCK CAP, MODEL 2C650
BAXTER HEALTHCARE CORP.           510(k) NO: K101385 (SPECIAL)
ATTN: NANETTE  HEDDEN             PHONE NO : 847 270 4871   
1620 WAUKEGAN ROAD                SE DECISION MADE: 22-JUN-10
MCGAW PARK IL 60085               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 21ST CENTURY CENTURION EXCELED, SYSTEM TWO LED
MEDICAL ILLUMINATION INTERNATIONAL510(k) NO: K100388 (TRADITIONAL)
ATTN: WAYNE  GEROW                PHONE NO : 818 838 3025   
547 LIBRARY ST.                   SE DECISION MADE: 22-JUN-10
SAN FERNANDO CA 91340             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNICEM HM
3M ESPE AG DENTAL PRODUCTS        510(k) NO: K100908 (TRADITIONAL)
ATTN: DESI W SOEGIARTO            PHONE NO : 498 152 7001169
ESPE PLATZ                        SE DECISION MADE: 22-JUN-10
SEEFELD, BAVARIA    GM D-82229    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TALLADIUM INTERNATIONAL IMPLANTOLOGY ABUTMENTS
TALLADIUM ESPANA S.L.             510(k) NO: K090081 (TRADITIONAL)
ATTN: DIANE  HORWITZ              PHONE NO : 703 307 2921   
PLAZA UTXESA 7, 5 A               SE DECISION MADE: 22-JUN-10
LLEIDA    SP 25002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BACK-TEK
YORK BIOMEDICAL INC               510(k) NO: K101227 (TRADITIONAL)
ATTN: CALLEY  HERZOG              PHONE NO : 720 883 3633   
13417 QUIVAS ST                   SE DECISION MADE: 23-JUN-10
WESTMINSTER CO 80234              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MIRADA XD VERSION 3.0
MIRADA MEDICAL LTD.               510(k) NO: K101228 (TRADITIONAL)
ATTN: GWILYM  OWEN                PHONE NO : 44 186 5811172
MILL STREET INNOVATION HOUSE      SE DECISION MADE: 23-JUN-10
OXFORD, OXFORDSHIRE    UK OX2 0JX 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: B-GENIN AND R-GENIN
BERKELEY ADVANCED BIOMATERIALS, IN510(k) NO: K091912 (TRADITIONAL)
ATTN: FRANCOIS  GENIN             PHONE NO : 510 883 0500   
901 GRAYSON ST., SUITE 101        SE DECISION MADE: 23-JUN-10
BERKELEY CA 94710                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAM TWISTER
MAM INTERNATIONAL AG              510(k) NO: K092781 (TRADITIONAL)
ATTN: MICHAEL  TEDESCO            PHONE NO : 914 269 2500   
CORPORATE PARK DRIVE 106          SE DECISION MADE: 23-JUN-10
WHITE PLAINS NY 10604             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS
BONUTTI RESEARCH, INC.            510(k) NO: K093078 (SPECIAL)
ATTN: PATRICK G BALSMANN          PHONE NO : 217 342 3412   
2600 SOUTH RANEY P.O. BOX 1367    SE DECISION MADE: 23-JUN-10
EFFINGHAM IL 62401                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CEDARA WEBACCESS, MODEL: 2.4
CEDARA SOFTWARE CORP.             510(k) NO: K092915 (TRADITIONAL)
ATTN: CAROL  NAKAGAWA             PHONE NO : 905 672 2100
6509 AIRPORT RD.                  SE DECISION MADE: 23-JUN-10
MISSISSAUGA, ONTARIO    CA L4V 1S7510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C
MEDRAD, INC.                      510(k) NO: K100798 (TRADITIONAL)
ATTN: SUSAN LYNN  FELIX           PHONE NO : 412 406 3115   
ONE MEDRAD DR.                    SE DECISION MADE: 23-JUN-10
INDIANOLA PA 15051                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NUVASIVE VUEPOINT OCT SYSTEM
NUVASIVE, INC.                    510(k) NO: K093319 (SPECIAL)
ATTN: SHEILA  BRUSCHI             PHONE NO : 858 320 4515   
7475 LUSK BLVD                    SE DECISION MADE: 23-JUN-10
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL  PRONTO-7
MASIMO CORPORATION                510(k) NO: K100403 (TRADITIONAL)
ATTN: MARGUERITE  THOMLINSON      PHONE NO : 949 297 7000   
40 PARKER                         SE DECISION MADE: 23-JUN-10
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM
BIOMET SPINE (AKA EBI, LLC)       510(k) NO: K100409 (SPECIAL)
ATTN: VIVIAN  KELLY MS, RAC       PHONE NO : 973 299 9300   
100 INTERPACE PARKWAY             SE DECISION MADE: 23-JUN-10
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACL TIGHTROPE
ARTHREX, INC.                     510(k) NO: K100652 (SPECIAL)
ATTN: GEENA  AUGUSTINE            PHONE NO : 239 643 5553   
1370 CREEKSIDE BLVD.              SE DECISION MADE: 23-JUN-10
NAPLES FL 34108 1945              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM
EBI, L.P.                         510(k) NO: K100438 (SPECIAL)
ATTN: VIVIAN  KELLY               PHONE NO : 973 299 9300   
100 INTERPACE PKWY.               SE DECISION MADE: 23-JUN-10
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820
U&I CORP.                         510(k) NO: K093707 (TRADITIONAL)
ATTN: GYEONG-JE  KWON             PHONE NO : 823 185 20102
529-1 YONGHYUN-DONG               SE DECISION MADE: 23-JUN-10
EUIJUNGBU, KYUNGGI-DO    KS 480-05510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORONIS FUSION 10MP, MODEL MDCG-10130
BARCO NV                          510(k) NO: K093197 (TRADITIONAL)
ATTN: LIEVEN  DE WANDEL           PHONE NO : 32 56 233211
35 PRESIDENT KENNEDYPARK          SE DECISION MADE: 23-JUN-10
KORTRIJK    BE B-8500             510(k) STATEMENT

DEVICE: KAI SPOT MODEL KMS 200
KAI MEDICAL, INC.                 510(k) NO: K100773 (SPECIAL)
ATTN: ROBERT  NAKATA              PHONE NO : 808 687 2900   
3465 WAIALAE AVE SUITE 370        SE DECISION MADE: 23-JUN-10
HONOLULU HI 96816                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAC-MOBILE AQUATIC CHAIR
REHAMED INTL. LLC.                510(k) NO: K101217 (TRADITIONAL)
ATTN: JOHN  CADEN                 PHONE NO : 305 586 7779   
522 WEST MOWRY DRIVE              SE DECISION MADE: 23-JUN-10
HOMESTEAD FL 33030                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH
ABBOTT VASCULAR-CARDIAC THERAPIES 510(k) NO: K101116 (SPECIAL)
ATTN: KAY  SETZER                 PHONE NO : 951 914 3242   
26531 YNEZ RD. MAILING P.O. BOX 90SE DECISION MADE: 23-JUN-10
TEMECULA CA 92589 9018            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOMERS TRANSLUCENT ORTHODONTIC BRACKET
BIOMED PRODUCTS LLC.              510(k) NO: K101481 (TRADITIONAL)
ATTN: GEORGE  ALIPHTIRAS          PHONE NO : 425 784 3000   
18912 NORTH CREEK PARKWAY SUITE 21SE DECISION MADE: 23-JUN-10
BOTHELL WA 98011                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: 8 CHANNEL CARDIAC PHASED ARRAY COIL
GE HEALTHCARE COILS (USA INSTRUMEN510(k) NO: K101492 (TRADITIONAL)
ATTN: MICHAEL S PRETO             PHONE NO : 330 995 8333   
1515 DANNER DR                    SE DECISION MADE: 23-JUN-10
AURORA OH 44202 9273              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: SLEEVE WITH ZIPLOOP FIXATION DEVICES
BIOMET SPORTS MEDICINE            510(k) NO: K101063 (TRADITIONAL)
ATTN: ROBERT  FRIDDLE             PHONE NO : 574 267 6639   
56 EAST BELL DRIVE P.O. BOX 587   SE DECISION MADE: 23-JUN-10
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOFORM DENTAL TEMPLATE
MESYNTHES LTD                     510(k) NO: K101546 (SPECIAL)
ATTN: MARY  MCNAMARA              PHONE NO : 508 643 0434   
49 PLAIN STREET                   SE DECISION MADE: 23-JUN-10
NORTH ATTLEBORO MA 02760 2237     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VASOVAPOR
LEXION MEDICAL, LLC.              510(k) NO: K101320 (TRADITIONAL)
ATTN: BERNARD  HORWATH            PHONE NO : 651 635 0000   
5000 TOWNSHIP PKWY                SE DECISION MADE: 24-JUN-10
ST. PAUL MN 55110                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERN'S S250 NORDAM
CEFLA S.C.                        510(k) NO: K092917 (ABBREVIATED)

ATTN: BERTHOIN  CLAUDE            PHONE NO : 386 672 0450   
110 E. GRANADA BLVD. SUITE 207    SE DECISION MADE: 24-JUN-10
ORMOND BEACH FL 32176             510(k) STATEMENT

DEVICE: ECHOBRIGHT
LIFE-TECH, INC.                   510(k) NO: K093662 (TRADITIONAL)
ATTN: JEFF  KASOFF                PHONE NO : 281 491 6600   
13235 NORTH PROMENADE BLVD.       SE DECISION MADE: 24-JUN-10
STAFFORD TX 77477                 510(k) STATEMENT

DEVICE: PRUCLAIR NONSTEROIDAL CREAM
PRUGEN IP HOLDINGS, INC           510(k) NO: K093156 (TRADITIONAL)
ATTN: ROBERT L KNECHTEL           PHONE NO : 480 563 2406   
8711 E PINNACLE PEAK ROAD SUITE C-SE DECISION MADE: 24-JUN-10
SCOTTSDALE AZ 85255               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PR CREAM
PRUGEN IP HOLDINGS, INC           510(k) NO: K093159 (TRADITIONAL)
ATTN: ROBERT L KNECHTEL           PHONE NO : 480 563 2408   
8711 E PINNACLE PEAK ROAD SUITE C-SE DECISION MADE: 24-JUN-10
SCOTTSDALE AZ 85255               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DARCO HEADED CANNULATED SCREW
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K100359 (TRADITIONAL)
ATTN: KELSEY  LEE                 PHONE NO : 901 290 5909   
5677 AIRLINE RD.                  SE DECISION MADE: 24-JUN-10
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MARROMAX B ONE MARROW ASPIRATION NEEDLE KIT, MODELS 50083-XX, 50084-XX
NEEDLETECH PRODUCTS, INC.         510(k) NO: K100665 (ABBREVIATED)

ATTN: RICK  TRIPP                 PHONE NO : 508 431 4000   
81 WEST ST.                       SE DECISION MADE: 24-JUN-10
ATTLEBORO MA 02703                510(k) STATEMENT

DEVICE: CONSENSUS REVISION KNEE SYSTEM
CONSENSUS ORTHOPEDICS, INC        510(k) NO: K100542 (TRADITIONAL)
ATTN: LUKE  ROSE                  PHONE NO : 916 355 7156   
1115 WINFIELD WAY SUITE 100       SE DECISION MADE: 24-JUN-10
ELDORADO HILLS CA 95762 9623      510(k) STATEMENT

DEVICE: MULTI- UNIT ABUTMENTS FOR STRAUMANN AND ASTRA TECH IMPLANT SYSTEMS
NOBELBIOCARE AB                   510(k) NO: K093643 (TRADITIONAL)
ATTN: HERBERT  CRANE              PHONE NO : 714 282 4800   
22715 SAVI RANCH PARKWAY          SE DECISION MADE: 24-JUN-10
YORBA LINDA CA 92887              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD DIRECTIGEN EX FLU A+B
BECTON, DICKINSON AND COMPANY     510(k) NO: K101461 (SPECIAL)
ATTN: GREGORY  PAYNE              PHONE NO : 858 795 7890   
11085 NORTH TORREY PINES ROAD SUITSE DECISION MADE: 24-JUN-10
LA JOLLA CA 92037                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AEDIS(TM)
EMBED TECHNOLOGY LLC              510(k) NO: K100902 (ABBREVIATED)

ATTN: HOWARD  STAMER              PHONE NO : 312 265 0065   
161 EAST CHICAGO AVE SUITE 37F    SE DECISION MADE: 24-JUN-10
CHICAGO IL 60611                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D
DIAMOND DIAGNOSTICS, INC.         510(k) NO: K093357 (TRADITIONAL)
ATTN: KATHY  CRUZ                 PHONE NO : 508 429 0450   
333 FISKE ST.                     SE DECISION MADE: 24-JUN-10
HOLLISTON MA 01746                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REPROCESSED PINS
STERILMED, INC.                   510(k) NO: K100707 (SPECIAL)
ATTN: GARRETT  AHLBORG            PHONE NO : 763 488 3483   
11400 73RD AVE. N.                SE DECISION MADE: 25-JUN-10
MAPLE GROVE MN 55369              510(k) STATEMENT

DEVICE: LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA
R2 DIAGNOSTICS, INC.              510(k) NO: K083878 (TRADITIONAL)
ATTN: MARC D GOLDFORD             PHONE NO : 574 288 4377   
1801 COMMERCE DR.                 SE DECISION MADE: 25-JUN-10
SOUTH BEND IN 46628               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54  TORIC MULTIFOCAL CONTACT LENSES
ALDEN OPTICAL LABS., INC.         510(k) NO: K091327 (SPECIAL)
ATTN: CHARLES  CREIGHTON          PHONE NO : 716 937 9181   
13295 BROADWAY                    SE DECISION MADE: 25-JUN-10
ALDEN NY 14004                    510(k) STATEMENT

DEVICE: SURGIMESH XD
ASPIDE MEDICAL                    510(k) NO: K092233 (TRADITIONAL)
ATTN: HOWARD M HOLSTEIN           PHONE NO : 202 637 5813   
555 THIRTEENTH ST. NW COLUMBIA SQUSE DECISION MADE: 25-JUN-10
WASHINGTON DC 20004 1109          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SET
IMMUNODIAGNOSTIC SYSTEMS, INC.    510(k) NO: K091849 (TRADITIONAL)
ATTN: KEN  GIBBS                  PHONE NO : 480 836 7435   
17029 EAST ENTERPRISE DR. SUITE 1 SE DECISION MADE: 25-JUN-10
FOUNTAIN HILLS AZ 85268           510(k) STATEMENT

DEVICE: OCTO
DALIM SURGNET CORPORATION         510(k) NO: K100045 (TRADITIONAL)
ATTN: PETER  CHUNG                PHONE NO : 412 687 3976   
300 ATWOOD                        SE DECISION MADE: 25-JUN-10
PITTSBURGH PA 15213               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTEC OSTEO-PLATE AND SCREW FIXATION
SYNTEC SCIENTIFIC CORP.           510(k) NO: K092889 (TRADITIONAL)
ATTN: CAROL  CHANG                PHONE NO : 886 227 787396
3F1. 96 CHUNG HSIAO E. RD. SEC. 3 SE DECISION MADE: 25-JUN-10
TAIPEI    TW 106                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09
COUSIN BIOTECH S.A.S.             510(k) NO: K093196 (ABBREVIATED)

ATTN: FRANCK  PELLETIER           PHONE NO : 33 320 144000
8 RUE DE L'ABBE BONPAIN           SE DECISION MADE: 25-JUN-10
WERVICQ-SUD    FR 59117           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDYSSEY CO., LTD., ZENIUS SPINAL SYSTEM
MEDYSSEY CO., LTD.                510(k) NO: K093104 (TRADITIONAL)
ATTN: PATRICK D MOORE             PHONE NO : 801 266 4811   
6170 SOUTH 380 WEST SUITE 200     SE DECISION MADE: 25-JUN-10
MURRAY UT 84107                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MOBIVISION
ALMANA MEDICAL IMAGING            510(k) NO: K100001 (TRADITIONAL)
ATTN: DANIEL  KAMM, P.E.          PHONE NO : 239 234 1735   
8726 FERRARA CT                   SE DECISION MADE: 25-JUN-10
NAPLES FL 34114                   510(k) STATEMENT

DEVICE: 4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV, WL-2504A
WELL-LIFE HEALTHCARE LIMITED      510(k) NO: K100399 (SPECIAL)
ATTN: JENNY  HSEIH                PHONE NO : 886 229 282112
1FL, NO.16, LANE 454 JUNGJENG RD. SE DECISION MADE: 25-JUN-10
YUNGHE CITY, TAIPEI COUNTY    TW  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN
TEKMEDIC (M) SDN BHD              510(k) NO: K100694 (TRADITIONAL)
ATTN: PATRICK  LEONG              PHONE NO : 606 351 0959
PLOT 4, TANJUNG KLING INDUSTRIAL ASE DECISION MADE: 25-JUN-10
JETTY, TANJUNG KLING, MELAKA    MY510(k) STATEMENT

DEVICE: MYOSCIENCE CRYO-TOUCH
MYOSCIENCE INC                    510(k) NO: K100447 (TRADITIONAL)
ATTN: TRACEY  HENRY               PHONE NO : 650 474 2600   
525 CHESAPEAKE DRIVE              SE DECISION MADE: 25-JUN-10
REDWOOD CITY CA 94063             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE
MEDTRONIC SOFAMOR DANEK           510(k) NO: K100214 (TRADITIONAL)
ATTN: LEE  GRANT                  PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 25-JUN-10
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZURA TEE SYSTEM WITH CLARITEE PROBE
IMACOR INC.                       510(k) NO: K100989 (TRADITIONAL)
ATTN: RICHARD  LANZILLOTTO        PHONE NO : 516 393 0970   
50 CHARLES LINDBERGH BLVD SUITE 20SE DECISION MADE: 25-JUN-10
UNIONDALE NY 11553                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS
C.R. BARD, INC.                   510(k) NO: K101431 (SPECIAL)
ATTN: JONI  CREAL                 PHONE NO : 480 638 2906   
1625 WEST 3RD ST. P.O. BOX 1740   SE DECISION MADE: 25-JUN-10
TEMPE AZ 85281 1740               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100
CARDICA, INC.                     510(k) NO: K101018 (SPECIAL)
ATTN: MATTHEW E CHROUST           PHONE NO : 650 331 7152   
900 SAGINAW DR.                   SE DECISION MADE: 25-JUN-10
REDWOOD CITY CA 94063             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SINGLE SITE FLEXIBLE BLADELESS OBTURATOR
TELEFLEX MEDICAL, INC.            510(k) NO: K101671 (SPECIAL)
ATTN: ANGELA  BOUSE               PHONE NO : 919 433 4904   
2917 WECK DR.                     SE DECISION MADE: 25-JUN-10
RESEARCH TRIANGLE PARK NC 27709   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K101639 (SPECIAL)
ATTN: CLAY  ANSELMO               PHONE NO : 303 223 4303   
555 ZANG STREET SUITE 100         SE DECISION MADE: 25-JUN-10
LAKEWOOD CO 80228                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Z.ONE ULTRA ULTRASOUND SYSTEM
ZONARE MEDICAL SYSTEMS, INC.      510(k) NO: K101091 (TRADITIONAL)
ATTN: LINDA  MOORE                PHONE NO : 650 230 2724   
420 NORTH BERNARDO AVENUE         SE DECISION MADE: 25-JUN-10
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MYLABTWICE, MODEL 6200
ESAOTE, S.P.A.                    510(k) NO: K100931 (TRADITIONAL)
ATTN: ALLISON  SCOTT              PHONE NO : 317 569 9500   
11460 N MERIDIAN ST., STE 150     SE DECISION MADE: 25-JUN-10
CARMEL IN 46032                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRYKER KNIFELIGHT
HOWMEDICA OSTEONICS CORP.         510(k) NO: K100884 (TRADITIONAL)
ATTN: AVITAL  MERL-MARGULIES      PHONE NO : 201 831 6365   
325 CORPORATE DRIVE               SE DECISION MADE: 25-JUN-10
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHIKANI SPEAKING VALVE
SHIKANI MEDICAL, LLC              510(k) NO: K100995 (TRADITIONAL)
ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   
24301 WOODSAGE DRIVE              SE DECISION MADE: 25-JUN-10
BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDPOR FIXATION SYSTEM
POREX SURGICAL, INC.              510(k) NO: K091807 (TRADITIONAL)
ATTN: JERRI  MANN                 PHONE NO : 770 515 7735   
15 DART RD.                       SE DECISION MADE: 28-JUN-10
NEWNAN GA 30265                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BELLECUP
LIBRETTE, INC                     510(k) NO: K092985 (TRADITIONAL)
ATTN: NEAL  KOLBER                PHONE NO : 512 327 9997   
1705. S. CAPITAL OF TEXAS HWY SUITSE DECISION MADE: 28-JUN-10
AUSTIN TX 78746                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K100322 (TRADITIONAL)
ATTN: DEBRA  LIANG                PHONE NO : 886 266 258188
6F, NO. 127, WUGONG 2ND RD WUGU TOSE DECISION MADE: 28-JUN-10
TAIPEI COUNTY    TW 248           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: G+ SYSTEM
GLYTEC, LLC (FORMALLY KNOWN AS GLU510(k) NO: K101344 (SPECIAL)
ATTN: WILLIAM  MATTHEWS           PHONE NO : 760 574 9476   
2607 WOODRUFF RD                  SE DECISION MADE: 28-JUN-10
SIMPSONVILLE SC 29681             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000
CALIBRA MEDICAL, INC.             510(k) NO: K100947 (SPECIAL)
ATTN: RICHARD J MEADER            PHONE NO : 650 298 4740   
220 SAGINAW DRIVE                 SE DECISION MADE: 28-JUN-10
REDWOOD CITY CA 94063             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WRIST ARTHRODESIS NAIL SYSTEM
SKELETAL DYNAMICS, LLC            510(k) NO: K092720 (TRADITIONAL)
ATTN: JOSEPH  AZARY               PHONE NO : 203 922 0105   
80 SHELDON TECHNOLOGY CENTER      SE DECISION MADE: 29-JUN-10
SHELTON CT 06484                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WAVESTATE NEUROMONITOR
WAVESTATE INC                     510(k) NO: K092625 (TRADITIONAL)
ATTN: E.J.  SMITH                 PHONE NO : 888 729 9674   
1468 HARWELL AVE                  SE DECISION MADE: 29-JUN-10
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MODIFICATION TO INTEL HEALTH GUIDE PHS6000
INTEL CORP.                       510(k) NO: K101178 (SPECIAL)
ATTN: MAUREEN  GLYNN              PHONE NO : 916 847 7794   
1900 PRAIRIE CITY RD., FM7-197    SE DECISION MADE: 29-JUN-10
FOLSOM CA 95630                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NITRITECH OR MULTIPLE PRIVATE LABEL NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVE
SUMMIT GLOVE, INC.                510(k) NO: K093517 (TRADITIONAL)
ATTN: JAMES  MOORE                PHONE NO : 330 868 0066   
310 SOUTH GRANT ST.               SE DECISION MADE: 29-JUN-10
MINERVA OH 44657                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: A4-XLR8 FOAM DRESSING
GENADYNE BIOTECHNOLOGIES, INC.    510(k) NO: K092992 (TRADITIONAL)
ATTN: E.J.  SMITH                 PHONE NO : 888 729 9674   
1468 HARWELL AVENUE               SE DECISION MADE: 29-JUN-10
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NITRITECH OR MULTIPLE PRIVATE LABEL NON STERILE POWDERED NITRILE EXAMINATION GLOVES
SUMMIT GLOVE, INC.                510(k) NO: K093516 (TRADITIONAL)
ATTN: JAMES  MOORE                PHONE NO : 330 868 0066   
310 SOUTH GRANT ST.               SE DECISION MADE: 29-JUN-10
MINERVA OH 44657                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LITETOUCH MASK
RESPIRONICS NEW JERSEY, INC.      510(k) NO: K100285 (TRADITIONAL)
ATTN: LAUREN  ZIEGLER             PHONE NO : 973 581 6008   
5 WOOD HOLLOW ROAD                SE DECISION MADE: 29-JUN-10
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: LATITUDE ELBOW PROSTHESIS
TORNIER, INC.                     510(k) NO: K100562 (SPECIAL)
ATTN: BRAHIM  HADRI               PHONE NO : 978 232 9997   
100 CUMMINGS CENTER SUITE 444C    SE DECISION MADE: 29-JUN-10
BEVERLY MA 01915                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RII INFRARED EAR THERMOMETER, MODEL: TH60N
RADIANT INNOVATION INC.           510(k) NO: K101253 (SPECIAL)
ATTN: JAMES  HUANG                PHONE NO : 886 361 11666
1F, NO. 3 INDUSTRIAL E. 9TH RD SCISE DECISION MADE: 29-JUN-10
HSIN CHU    TW                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965
ANDON HEALTH CO.,LTD              510(k) NO: K100940 (ABBREVIATED)

ATTN: LIU  YI                     PHONE NO : 86 22 60526161
NO 3,  JIN PING STREET NANKAI  DISSE DECISION MADE: 29-JUN-10
TIANJIN    CH 300190              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIPCOLLECTOR II
HUMAN MED AG                      510(k) NO: K101713 (TRADITIONAL)
ATTN: INGE  MATTHIESEN            PHONE NO : 493 853 95700
WILHELM-HENNEMANN-STR.9           SE DECISION MADE: 29-JUN-10
SCHWERIN    GM 19061              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: FRANKENMAN SURGICAL STAPLERS
SUZHOU FRANKENMAN MEDICAL EQUIPMEN510(k) NO: K101378(TRADITIONAL)ATTN: JEAN  ASQUITH               PHONE NO : 512 327 9997   
1705 S. CAPITAL OF TEXAS HWY SUITESE DECISION MADE: 29-JUN-10
AUSTIN TX 78746                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL 368774
BECTON DICKINSON & CO.            510(k) NO: K101502 (TRADITIONAL)
ATTN: MARY ANNE  ALSBERGE         PHONE NO : 201 847 3103   
1 BECTON DRIVE, MC300             SE DECISION MADE: 29-JUN-10
FRANKLIN LAKES NJ 07417 1885      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HANSON MEDICAL FACIAL IMPLANTS
HANSON MEDICAL, INC.              510(k) NO: K090803 (TRADITIONAL)
ATTN: GERALD  HANSON              PHONE NO : 800 771 2215   
2706 WASH BLVD. P.O. BOX 1160     SE DECISION MADE: 30-JUN-10
KINGSTON WA 98346                 510(k) STATEMENT

DEVICE: S-LIF INTERVERTEBRAL BODY FUSION DEVICE
SPINEFRONTIER, INC.               510(k) NO: K092815 (ABBREVIATED)

ATTN: JOHN  SULLIVAN              PHONE NO : 978 232 3990   
500 CUMMINGS CENTER, STE. 3500    SE DECISION MADE: 30-JUN-10
BEVERLY MA 01915                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70
INFRAREDX, INC.                   510(k) NO: K093993 (TRADITIONAL)
ATTN: STEVEN J CHARTIER           PHONE NO : 781 345 9593   
34 THIRD AVE                      SE DECISION MADE: 30-JUN-10
BURLINGTON MA 01803 4414          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PEEK PREVAIL CERVICAL INTERBODY DEVICE
MEDTRONIC SOFAMOR DANEK           510(k) NO: K094042 (TRADITIONAL)
ATTN: JUSTINE  VIERA              PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 30-JUN-10
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TYCHE PEDICLE SCREW SYSTEM
KYUNGWON MEDICAL CO., LTD.        510(k) NO: K100373 (TRADITIONAL)
ATTN: JOYCE  BANG                 PHONE NO : 562 404 8466   
13340 E FIRESTONE BLVD. SUITE J   SE DECISION MADE: 30-JUN-10
SANTA FE SPRINGS CA 90670         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZEN CORDLESS PROPHY SYSTEM
DISCUS DENTAL, LLC                510(k) NO: K101612 (TRADITIONAL)
ATTN: WINKIE  WONG                PHONE NO : 310 845 8339   
8550 HIGUERA ST.                  SE DECISION MADE: 30-JUN-10
CULVER CITY CA 90232              510(k) STATEMENT
                                  THIRD PARTY REVIEW

DEVICE: APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810, 303210,303610,304010
OMNLIFE SCIENCE                   510(k) NO: K101575 (SPECIAL)
ATTN: RADHIKA  PONDICHERRY        PHONE NO : 774 226 1852   
50 O'CONNELL WAY                  SE DECISION MADE: 30-JUN-10
EAST TAUNTON MA 02718             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UROSKOP OMNIA
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K101491 (SPECIAL)
ATTN: GARY  JOHNSON               PHONE NO : 610 448 1778   
51 VALLEY STREAM PKWY.            SE DECISION MADE: 30-JUN-10
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA


                                                 TOTAL 510(k)s THIS PERIOD   243
                                                 TOTAL WITH SUMMARIES        214
                                                 TOTAL WITH STATEMENTS        29
    
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