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510(k) Final Decisions - May 2010

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


DEVICE: ENGSTROM CARESTATION, ENGSTROM PRO
DATEX-OHMEDA INC., A DIVISION OF I510(k) NO: K093886 (TRADITIONAL)

ATTN: JIM RASKOB PHONE NO : 608 221 1551 3030 OHMEDA DRIVE SE DECISION MADE: 03-MAY-10 MADISON WI 53718 6794 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASCAL STREAMLINE PHOTOCOAGULATOR OPTIMEDICA CORPORATION 510(k) NO: K100019 (TRADITIONAL)
ATTN: DARLENE CROCKETT-BILLING PHONE NO : 408 400 0856 155-A MOFFETT PARK DRIVE SUITE 210SE DECISION MADE: 04-MAY-10 SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPERMCHECK FERTILITY PRINCETON BIOMEDITECH CORP. 510(k) NO: K100341 (TRADITIONAL)
ATTN: KYUNG-AH KIM PHONE NO : 732 274 1000 4242 U.S. RT. 1 SE DECISION MADE: 04-MAY-10 MONMOUTH JUNCTION NJ 08852 1905 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES BLACKSTONE MEDICAL, INC. 510(k) NO: K100614 (TRADITIONAL)
ATTN: DARLA CHEW PHONE NO : 469 742 8824 1211 HAMBURG TURNPIKE SUITE 300 SE DECISION MADE: 04-MAY-10 WAYNE NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DERMABOND NX ADHESIVE MODEL: DNX6, DNX12 ETHICON, INC. 510(k) NO: K100423 (TRADITIONAL)
ATTN: NEELU MEDHEKAR PHONE NO : 919 876 7800 PO BOX 151, ROUTE 22 WEST SE DECISION MADE: 04-MAY-10 SOMERVILLE NJ 08876 0151 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES COVIDIEN 510(k) NO: K100306 (TRADITIONAL)
ATTN: MIA PROLI PHONE NO : 508 261 8037 15 HAMPSHIRE STREET SE DECISION MADE: 04-MAY-10 MANSFIELD MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMOSIL F11 & FV DNA CONTROL INSTRUMENTATION LABORATORY CO. 510(k) NO: K093737 (TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781 861 4467 180 BEDFORD ROAD SE DECISION MADE: 04-MAY-10 BEDFORD MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA HYGIA HEALTH SERVICES, INC. 510(k) NO: K100523 (TRADITIONAL)
ATTN: LAKE TRECHSEL PHONE NO : 205 314 3920 434 INDUSTRIAL LN. SE DECISION MADE: 04-MAY-10 BIRMINGHAM AL 35211 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150 SAFELIFE CORP. 510(k) NO: K100139 (TRADITIONAL)
ATTN: ALBERT REGO PHONE NO : 858 794 3200 12250 EL CAMINO REAL SUITE 350 SE DECISION MADE: 04-MAY-10 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES SMITH & NEPHEW, INC. 510(k) NO: K100325 (TRADITIONAL)
ATTN: LAURA MEDLIN PHONE NO : 901 399 5349 1450 BROOKS RD. SE DECISION MADE: 04-MAY-10 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K100830 (TRADITIONAL)
ATTN: ZHAI PEI PHONE NO : 867 552 6582888 MINDRAY BUILDING, KEJI 12TH RD SOUSE DECISION MADE: 05-MAY-10 NANSHAN,SHENZHEN, P.R. CHINA CH510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: FORA G31A/TD-4256A BLOOD GLUCOSE MONITORING SYSTEM AND FORA G31B/TD-4256B BLOOD GLUCOSE MONITORING SYSTEM TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K094005 (TRADITIONAL)
ATTN: NICKY PAN PHONE NO : 886 266 258188 6F, NO. 127, WUGONG 2ND RD WUGU TOSE DECISION MADE: 05-MAY-10 TAIPEI COUNTY TW 248 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR ZIBO YINGHAO MEDICAL PRODUCTS CO.,510(k) NO: K100486 (TRADITIONAL)
ATTN: FRANK LIU PHONE NO : 909 548 4828 12390 EAST END AVE SE DECISION MADE: 05-MAY-10 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGIQUEST ANCHORPORT SIL KIT SURGIQUEST, INC. 510(k) NO: K100180 (TRADITIONAL)
ATTN: KOUROSH AZARBARZIN PHONE NO : 203 799 2400 12 CASCADE BLVD. SUITE 2B SE DECISION MADE: 05-MAY-10 ORANGE CT 06477 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT MEDICA CORP. 510(k) NO: K100187 (TRADITIONAL)
ATTN: PHOTIOS MAKRIS PHONE NO : 781 275 4892 5 OAK PARK DRIVE SE DECISION MADE: 05-MAY-10 BEDFORD MA 01730 510(k) STATEMENT DEVICE: DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K100778 (TRADITIONAL)
ATTN: ROSE T MARINELLI PHONE NO : 302 631 8805 MS 514, PO BOX 6101 SE DECISION MADE: 05-MAY-10 NEWARK DE 19714 6101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B CAREMATIX INC. 510(k) NO: K100508 (SPECIAL)
ATTN: SUKHWANT KHANUJA PHONE NO : 312 627 9300 209 W. JACKSON BLVD. SUITE 800 SE DECISION MADE: 05-MAY-10 CHICAGO IL 60606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOLOX DELTA CERAMIC FEMORAL HEADS SMITH & NEPHEW, INC. 510(k) NO: K100412 (TRADITIONAL)
ATTN: MEGAN BEVILL PHONE NO : 901 399 5340 1450 BROOKS ROAD SE DECISION MADE: 05-MAY-10 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SLENDERTONE SYSTEM ULTRA MODEL E70/X70 BIO-MEDICAL RESEARCH, LTD. 510(k) NO: K100320 (SPECIAL)
ATTN: DEIRDRE BARROW PHONE NO : 353 917 74300 PARKMORE BUSINESS PARK, WEST SE DECISION MADE: 05-MAY-10 GALWAY EI 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARIE TENE PROGRIP MESH SOFRADIM PRODUCTION 510(k) NO: K101197 (SPECIAL)
ATTN: SHARON ALEXANDER PHONE NO : 203 492 6060 60 MIDDLETOWN AVENUE SE DECISION MADE: 05-MAY-10 NORTH HAVEN CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA, GREEN COLOR BETTERCARE PLASTIC PRODUCTS CO., L510(k) NO: K092302 (TRADITIONAL)
ATTN: JIE LIU PHONE NO : 909 590 1611 3973 SCHAEFER AVE SE DECISION MADE: 05-MAY-10 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MED CONTOUR GENERAL PROJECT S.R.L. 510(k) NO: K091615 (TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978 207 1245 5 TIMBER LANE SE DECISION MADE: 06-MAY-10 NORTH READING MA 01864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARI SINUS PARI RESPIRATORY EQUIPMENT, INC. 510(k) NO: K092560 (TRADITIONAL)
ATTN: MICHAEL JUDGE PHONE NO : 804 253 7274 2943 OAKLAKE BLVD. SE DECISION MADE: 06-MAY-10 MIDLOTHIAN VA 23112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A.B. KORKOR MEDICAL SKINNYSAFE INTRODUCER SHEATH A.B. KORKOR MEDICAL, INC. 510(k) NO: K092097 (TRADITIONAL)
ATTN: ANDREW BLACK PHONE NO : 847 620 7990 400 NORTH RAND ROAD SE DECISION MADE: 06-MAY-10 NORTH BARRINGTON IL 60010 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED BRAINLAB AG 510(k) NO: K092467 (SPECIAL)
ATTN: ALEXANDER DRUSE PHONE NO : 498 999 15680 KAPELLENSTRASSE 12 SE DECISION MADE: 06-MAY-10 FELDKIRCHEN GM 85622 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAREVENT HANDHELD CPAP SYSTEM O-TWO MEDICAL TECHNOLOGIES, INC. 510(k) NO: K093862 (TRADITIONAL)
ATTN: DAVID ZHANG PHONE NO : 905 677 9410 7575 KIMBEL ST. SE DECISION MADE: 06-MAY-10 MISSISSAUGA, ONTARIO CA L5S 1C8510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AEQUALIS REVERSED SHOULDER PROSTHESIS TORNIER 510(k) NO: K100142 (TRADITIONAL)
ATTN: SEVERIEN BONNETON PHONE NO : 003 347 6613500 161 RUE LAVOISIER SE DECISION MADE: 06-MAY-10 MONTBONNOT, SAINT-ISMIER FR 383510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000 STRYKER COMMUNICATIONS 510(k) NO: K100852 (TRADITIONAL)
ATTN: ALMA RELJA PHONE NO : 972 410 7279 1410 LAKESIDE PKWY., #100 SE DECISION MADE: 06-MAY-10 FLOWER MOUND TX 75028 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BUSSE SURGICAL DRAPES IV BUSSE HOSPITAL DISPOSABLES, INC. 510(k) NO: K093909 (TRADITIONAL)
ATTN: MUHAMAD ANSARI PHONE NO : 631 435 4711 75 ARKAY DR. SE DECISION MADE: 06-MAY-10 HAUPPAUGE NY 11788 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECTRUM TURBO-JECT PICC SET COOK INCORPORATED 510(k) NO: K100974 (SPECIAL)
ATTN: SUSANNE GALIN PHONE NO : 812 339 2235 750 DANIELS WAY SE DECISION MADE: 06-MAY-10 BLOOMINGTON IN 47404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6, IVNOW MODULAR FLUID WARMER 230V ENTHERMICS MEDICAL SYSTEMS, INC. 510(k) NO: K091336 (TRADITIONAL)
ATTN: EMALEE G MURPHY PHONE NO : 202 778 9428 1601 K STREET NW SE DECISION MADE: 07-MAY-10 WASHINGTON DC 20006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPORT-ELEC BODY CONTROL SYSTEM, MODEL 4M SPORT-ELEC 510(k) NO: K092476 (TRADITIONAL)
ATTN: KIMBERLY ROSS PHONE NO : 757 224 0177 141 RESEARCH DRIVE COMPLIANCE DEPTSE DECISION MADE: 07-MAY-10 HAMPTON VA 23666 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS FRONTIER DEVICES, INC. 510(k) NO: K091812 (TRADITIONAL)
ATTN: DON PETERSEN PHONE NO : 205 733 0901 153A CAHABA VALLEY PARKWAY SE DECISION MADE: 07-MAY-10 PELHAM AL 35124 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS C.R. BARD, INC. 510(k) NO: K093747 (SPECIAL)
ATTN: JOHN KNORPP PHONE NO : 770 784 6316 8195 INDUSTRIAL BLVD. SE DECISION MADE: 07-MAY-10 COVINGTON GA 30014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITALOGIK 6000/6500 MENNEN MEDICAL LTD. 510(k) NO: K093766 (SPECIAL)
ATTN: IFAT OREN SHWARTS PHONE NO : 972 8 9323333 4 HA-YARDEN ST. P.O. BOX 102 SE DECISION MADE: 07-MAY-10 YAVNE, REHOVOT IS 76100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM SPARTEK MEDICAL, INC. 510(k) NO: K094002 (TRADITIONAL)
ATTN: HENRY KLYCE PHONE NO : 510 545 4899 1100 MARINA VILLIAGE PKWY SUITE 10SE DECISION MADE: 07-MAY-10 ALAMEDA CA 94501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDCOM RT-VIEWER SYSTEM MEDCOM GMBH 510(k) NO: K100056 (TRADITIONAL)
ATTN: STEFAN WALTER PHONE NO : 49 615 19514717 12 RUNDETURMSTRASSE SE DECISION MADE: 07-MAY-10 DARMSTADT, HESSEN GM 64283 510(k) STATEMENT DEVICE: SYMBIA.NET, SYMBIA.NET SELECT MODEL 10520828, 10520827 SIEMENS MEDICAL SOLUTIONS USA INC.510(k) NO: K100619 (SPECIAL)
ATTN: ELAINE CHANG PHONE NO : 865 898 4170 2501 NORTH BARRINGTON ROAD SE DECISION MADE: 07-MAY-10 HOFFMAN ESTATES IL 60192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYALO GYN FIDIA FARMACEUTICI SPA 510(k) NO: K094039 (TRADITIONAL)
ATTN: GIUSI LOCASTRO PHONE NO : 390 498 232906 VIA PONTE DELLA FABBRICA 3/A SE DECISION MADE: 07-MAY-10 ABANO TERME, PADUA (PD) IT 3503510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLOOD PRESSURE MONITOR/ MODELS NINGBO DIAIER ELECTRONIC CO., LTD.510(k) NO: K093739 (SPECIAL)
ATTN: TONY C.S. CHANG PHONE NO : 886 422 972787 YAOXI INDUSTRIAL ZONE SE DECISION MADE: 07-MAY-10 YUYAO CITY, ZHEJIANG CH 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 MODEL: 863063, 863064, 863065, 863066, 863068 PHILIPS MEDICAL SYSTEMS 510(k) NO: K101067 (SPECIAL)
ATTN: PENG CUI PHONE NO : 978 659 7966 3000 MINUTEMAN RD. SE DECISION MADE: 07-MAY-10 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014L MEDTRONIC INC. 510(k) NO: K100274 (TRADITIONAL)
ATTN: CARALEE WALTON PHONE NO : 763 514 9851 7611 NORTHLAND DRIVE SE DECISION MADE: 10-MAY-10 MINNEAPOLIS MN 55428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARVIEW EXACT II INFLUENZA A & B TEST INVERNESS MEDICAL, INC. 510(k) NO: K092349 (TRADITIONAL)
ATTN: ANNE JEPSON PHONE NO : 207 730 5750 10 SOUTHGATE ROAD SE DECISION MADE: 10-MAY-10 SCARBOROUGH ME 04074 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACTIPROTECT UF N95 RESPIRATOR GLAXOSMITHKLINE CONSUMER HEALTHCAR510(k) NO: K093161 (ABBREVIATED)
ATTN: ZINATARA A MANJI PHONE NO : 973 889 2322 1500 LITTLETON RD. SE DECISION MADE: 10-MAY-10 PARSIPPANY NJ 07054 3884 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REDSENSE-HOME USE REDSENSE MEDICAL AB 510(k) NO: K092955 (TRADITIONAL)
ATTN: CONSTANCE G BUNDY PHONE NO : 763 574 1976 435 RICE CREEK TERRANCE SE DECISION MADE: 10-MAY-10 FRIDLEY MN 55432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEED RIVERPOINT MEDICAL 510(k) NO: K100006 (ABBREVIATED)
ATTN: DOUG ROWLEY PHONE NO : 503 517 8001 825 NE 25TH AVE. SE DECISION MADE: 10-MAY-10 PORTLAND OR 97232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CENTRAL VISION ANALYZER MODEL 1000 VIMETRICS,LLC. 510(k) NO: K100095 (ABBREVIATED)
ATTN: STEPHEN H H SINCLAIR,MD PHONE NO : 610 892 1708 311 E. BALTIMORE AVE SUITE 100 SE DECISION MADE: 10-MAY-10 MEDIA PA 19063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VLOC9ABSORBABLE WOUND CLOSURE DEVICE SURGICAL DEVICES, A DIVISION OF TY510(k) NO: K100257 (TRADITIONAL)
ATTN: JENNIFER BRENNAN PHONE NO : 203 492 5346 60 MIDDLETOWN AVE. SE DECISION MADE: 10-MAY-10 NORTH HAVEN CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SALVIN DENTAL SPECIALTIES FIXATION SCREW SALVIN DENTAL SPECIALTIES, INC. 510(k) NO: K100182 (TRADITIONAL)
ATTN: ROBERT SALVIN PHONE NO : 704 442 5400 3450 LATROBE DR. SE DECISION MADE: 10-MAY-10 CHARLOTTE NC 28211 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EPIDRUM EXMOOR PLASTICS LTD. 510(k) NO: K093863 (TRADITIONAL)
ATTN: MARGARET BLACKMORE PHONE NO : 044 823 351040 LISIEUX WAY SE DECISION MADE: 10-MAY-10 TAUNTON, SOMERSET UK TA1 2LB 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTCO TAB ELECTRODE SHANGHAI INTCO ELECTRODE MANUFACTU510(k) NO: K093327 (ABBREVIATED)
ATTN: CHRIS HEALY PHONE NO : 208 263 5071 814 AIRPORT WAY SE DECISION MADE: 10-MAY-10 SANDPOINT ID 83864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE IMBIOTECHNOLOGIES 510(k) NO: K093813 (TRADITIONAL)
ATTN: ROSINA ROBINSON PHONE NO : 508 643 0434 49 PLAIN STREET SE DECISION MADE: 10-MAY-10 NORTH ATTLEBORO MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781 SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K100289 (TRADITIONAL)
ATTN: SANDRA D WHITE PHONE NO : 508 660 4553 333 CONEY STREET SE DECISION MADE: 10-MAY-10 WALPOLE MA 02032 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM BL HEALTHCARE, INC. 510(k) NO: K101078 (SPECIAL)
ATTN: MICHAEL MATHUR PHONE NO : 508 543 4150 33 COMMERCIAL ST., SUITE #3 SE DECISION MADE: 10-MAY-10 FOXBORO MA 02035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES (USA) 2.7MM/ 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATES SYNTHES (USA) 510(k) NO: K092812 (TRADITIONAL)
ATTN: KARL J NITTINGER PHONE NO : 610 719 6941 1301 GOSHEN PKWY. SE DECISION MADE: 11-MAY-10 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACE STAPLER, MODEL F0031 BAROSENSE, INC 510(k) NO: K082044 (TRADITIONAL)
ATTN: DANIEL J BALBIERZ PHONE NO : 650 362 6001 3698-C HAVEN AVENUE SE DECISION MADE: 11-MAY-10 REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS SYNTHES (USA) 510(k) NO: K092190 (TRADITIONAL)
ATTN: JILL R YELTON PHONE NO : 610 719 6538 1301 GOSHEN PKWY. SE DECISION MADE: 11-MAY-10 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIT-Z ZITERION 510(k) NO: K092507 (TRADITIONAL)
ATTN: STEFFEN KAHDEMANN PHONE NO : 499 842 9369 BAHNHOFSTRASSE 3 SE DECISION MADE: 11-MAY-10 UFFENHEIM GM 97215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VELA VENTILATOR CARDINAL HEALTH 207, INC. 510(k) NO: K093094(TRADITIONAL) ATTN: FAROKH ETEMADIEH PHONE NO : 714 901 3249 22745 SAVI RANCH PARKWAY SE DECISION MADE: 11-MAY-10 YORBA LINDA CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM EXACTECH, INC. 510(k) NO: K093978 (TRADITIONAL)
ATTN: SHING JEN TAI PHONE NO : 352 377 1140 2320 N.W. 66TH CT. SE DECISION MADE: 11-MAY-10 GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEARLSCENT BLACK TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES, COATED WITH ALOE VERA SHEN WEI (USA), INC. 510(k) NO: K100211 (TRADITIONAL)
ATTN: BELLE CHOU PHONE NO : 540 429 8692 33278 CENTRAL AVE., SUITE 102 SE DECISION MADE: 11-MAY-10 UNION CITY CA 94587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTELLIVUE PATIENT MONITOR PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K093268 (TRADITIONAL)
ATTN: ANDREAS SUCHI PHONE NO : 497 031 4631291 HEWLETT-PACKARD STR.2 SE DECISION MADE: 11-MAY-10 BOEBLINGEN GM D 71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZZOMA POSITIONAL SLEEPER MODEL 001 SLEEP SPECIALISTS, LLC 510(k) NO: K100160 (TRADITIONAL)
ATTN: HOWARD MANN PHONE NO : 267 566 3078 1 CONGRESSIONAL DRIVE APT C SE DECISION MADE: 11-MAY-10 GREENVILLE DE 19807 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AESCULAP STERILCONTAINER S AESCULAP 510(k) NO: K093649 (TRADITIONAL)
ATTN: KATHY RACOSKY PHONE NO : 610 984 9291 3773 CORPORATE PKWY. SE DECISION MADE: 11-MAY-10 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM DEPUY ORTHOPAEDICS, INC. 510(k) NO: K100238 (TRADITIONAL)
ATTN: SUZANA OTANO PHONE NO : 305 269 6386 700 ORTHOPAEDIC DR. SE DECISION MADE: 11-MAY-10 WARSAW IN 46581 0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORA V20 BLOOD GLUCOSE MONITORING SYSTEM TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K100406 (SPECIAL)
ATTN: NICKY PAN PHONE NO : 886 266 258188 3F,5F, NO.127 WUGONG 2ND RD. WUGU SE DECISION MADE: 11-MAY-10 TAIPEI COUNTY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500 BIONIX DEVELOPMENT CORP. 510(k) NO: K100691 (TRADITIONAL)
ATTN: JAMES HUTTNER PHONE NO : 419 727 8421 5154 ENTERPRISE BLVD. SE DECISION MADE: 11-MAY-10 TOLEDO OH 43612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARIREP GORBEC PHARMACEUTICAL SERVICES, IN510(k) NO: K100839 (TRADITIONAL)
ATTN: MATTHEW POPP PHONE NO : 919 281 4080 2445 SOUTH ALSTON AVENUE SE DECISION MADE: 11-MAY-10 DURHAM NC 27713 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEMPUS IC PROFESSIONAL PATIENT MONITOR REMOTE DIAGNOSTIC TECHNOLOGIES LTD510(k) NO: K101264 (TRADITIONAL)
ATTN: CHRIS HANNAN PHONE NO : 441 256 362411 THE OLD COACH HOUSE, THE AV. FARLESE DECISION MADE: 11-MAY-10 HAMPSHIRE UK RG25 2HT 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE 3M COMPANY 510(k) NO: K100235 (TRADITIONAL)
ATTN: SCOTT ERICKSON PHONE NO : 651 736 9883 3M CENTER,BLDG. 275-2W-08 SE DECISION MADE: 12-MAY-10 ST. PAUL MN 55144 1000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINXRAY, MODEL: BPD60 MINXRAY, INC. 510(k) NO: K091255(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 847 374 8854 333 MILFORD RD. SE DECISION MADE: 12-MAY-10 DEERFIELD IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BWF-5 MEDICAL LASER SERIES LITECURE, LLC 510(k) NO: K093087 (TRADITIONAL)
ATTN: LIANG LU PHONE NO : 302 709 0408 250 CORPORATE BLVD., SUITE B SE DECISION MADE: 12-MAY-10 NEWARK DE 19702 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU INNOLATEX (THAILAND) LIMITED 510(k) NO: K092586 (ABBREVIATED)
ATTN: GOH SAING PHONE NO : 667 420 6111 SOUTHERN INDUSTRIAL ESTATE VILLAGESE DECISION MADE: 12-MAY-10 HATYAI DISTRICT, SONGKHLA TH 90510(k) STATEMENT DEVICE: EASYCELL CELL LOCATOR MEDICA CORP. 510(k) NO: K092116 (TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978 927 3808 163 CABOT STREET SE DECISION MADE: 12-MAY-10 BEVERLY MA 01915 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K092789 (TRADITIONAL)
ATTN: CHRISTINA THOMAS PHONE NO : 734 741 6278 6200 JACKSON RD. SE DECISION MADE: 12-MAY-10 ANN ARBOR MI 48103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NAVIGATOR CLINICAL GUIDENCE SYSTEM APPLIED PHYSIOLOGY PTY LTD. 510(k) NO: K092219 (TRADITIONAL)
ATTN: ROBERT N CLARK PHONE NO : 303 463 0900 13605 W. 7TH AVE. SE DECISION MADE: 12-MAY-10 GOLDEN CO 80401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAPNOSTREAM20 WITH MICROMEDICO2 MODULE ORIDION CAPNOGRAPHY, INC. 510(k) NO: K094012 (SPECIAL)
ATTN: RACHEL WEISSBROD PHONE NO : 972 258 9911 160 GOULD STREET SE DECISION MADE: 12-MAY-10 NEEDHAM MA 02494 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY MICROGENICS CORP. 510(k) NO: K093114 (TRADITIONAL)
ATTN: HEWUAN TAKKELE PHONE NO : 510 979 5000 46360 FREMONT BLVD SE DECISION MADE: 12-MAY-10 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLANMECA PROMAX 3D MAX PLANMECA OY 510(k) NO: K093590 (TRADITIONAL)
ATTN: LARS MORING PHONE NO : 358 207 795500 ASENTAJANKATU 6 SE DECISION MADE: 12-MAY-10 HELSINKI FI 00880 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRILOGY 202 VENTILATOR RESPIRONICS, INC. 510(k) NO: K093905 (ABBREVIATED)
ATTN: JOSEPH OLSAVSKY PHONE NO : 724 387 7562 1740 GOLDEN MILE HIGHWAY SE DECISION MADE: 12-MAY-10 MONROEVILLE PA 15146 510(k) STATEMENT DEVICE: EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277 BIOTEST MEDICAL CORP. 510(k) NO: K100560 (SPECIAL)
ATTN: MAGGIE CHU PHONE NO : 866 425 326668 NO.3-2, CHIEN-KUO ROAD, TEPZ TANTZSE DECISION MADE: 12-MAY-10 TAICHUNG TW 427 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711 ERAGEN BIOSCIENCES 510(k) NO: K100336 (TRADITIONAL)
ATTN: RANDAL VADER PHONE NO : 608 662 9000 918 DEMING WAY SUITE 201 SE DECISION MADE: 12-MAY-10 MADISON WI 53717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PULPDENT COPAL VARNISH WITH FLUORIDE PULPDENT CORPORATION 510(k) NO: K100503 (TRADITIONAL)
ATTN: KENNETH J BERK PHONE NO : 617 926 6666 80 OAKLAND ST. SE DECISION MADE: 12-MAY-10 WATERTOWN MA 02472 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE MOSES APPLIANCE ALLEN J. MOSES, DDS, LTD. 510(k) NO: K093710 (ABBREVIATED)
ATTN: ALLEN J MOSES PHONE NO : 312 993 4030 233 S. WACKER DR. SE DECISION MADE: 12-MAY-10 CHICAGO IL 60606 510(k) STATEMENT DEVICE: REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE ASCENT HEALTHCARE SOLUTIONS 510(k) NO: K100537 (TRADITIONAL)
ATTN: RAMONA KULIK PHONE NO : 480 763 2952 10232 SOUTH 51ST ST. SE DECISION MADE: 12-MAY-10 PHOENIX AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLIDER PTA BALLOON CATHETER TRIREME MEDICAL INC 510(k) NO: K101062 (SPECIAL)
ATTN: SHIVA ARDAKANI PHONE NO : 925 931 1300 7060 KNOLL CENTER PARKWAY SUITE 30SE DECISION MADE: 12-MAY-10 PLEASANTON CA 94566 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NUANCE DISCUS DENTAL, LLC 510(k) NO: K101215 (TRADITIONAL)
ATTN: WINKIE WONG PHONE NO : 310 845 8339 8550 HIGUERA ST. SE DECISION MADE: 12-MAY-10 CULVER CITY CA 90232 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: LEGION POROUS + HA TIBIAL BASEPLATES SMITH & NEPHEW, INC. 510(k) NO: K100897 (SPECIAL)
ATTN: MEGAN BEVILL PHONE NO : 901 399 5340 1450 E BROOKS ROAD SE DECISION MADE: 13-MAY-10 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA SHENZHEN DELICATE ELECTRONICS CO.,510(k) NO: K092164 (TRADITIONAL)
ATTN: WILLIAM STERN PHONE NO : 914 376 5200 1 ODELL PLAZA SE DECISION MADE: 13-MAY-10 YONKERS NY 10701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES T-PAL SPACER SYNTHES SPINE 510(k) NO: K100089 (TRADITIONAL)
ATTN: HEATHER GUERIN PHONE NO : 610 719 5432 1302 WRIGHTS LANE EAST SE DECISION MADE: 13-MAY-10 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LENSAR LASER SYSTEM LENSAR, INC. 510(k) NO: K090633 (TRADITIONAL)
ATTN: SHIRLEY MCGARVEY PHONE NO : 702 524 3701 250 SOUTH PARK AVE., SUITE 310 SE DECISION MADE: 13-MAY-10 WINTER PARK FL 32789 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINEWAND SURGICAL DEVICE ARTHROCARE CORP. 510(k) NO: K100353 (SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408 736 0224 680 VAQUEROS AVE. SE DECISION MADE: 13-MAY-10 SUNNYVALE CA 94085 3523 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) SHIJIAZHUANG UNIVERSAL CHANNEL PLA510(k) NO: K100697 (TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441 ROOM 1606 BLDG, 1 JIANXIANG YUAN NSE DECISION MADE: 13-MAY-10 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2, SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K100433 (TRADITIONAL)
ATTN: ROBERT C EUSEBIO PHONE NO : 916 374 3183 1584 ENTERPRISE BLVD SE DECISION MADE: 13-MAY-10 WEST SACRAMENTO CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIAMOND ANTERIOR CERVICAL PLATE SYSTEM AMENDIA, INC. 510(k) NO: K100265 (TRADITIONAL)
ATTN: TIM LUSBY PHONE NO : 770 874 0935 1155 ALLGOOD RD. SUITE 6 SE DECISION MADE: 13-MAY-10 MARIETTA GA 30062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BABI PLUS INFANT NASAL CANNULA SYSTEM A PLUS MEDICAL 510(k) NO: K093716 (TRADITIONAL)
ATTN: TOM LOESCHER PHONE NO : 760 930 4025 5431 AVENIDA ENCINAS SUITE G SE DECISION MADE: 13-MAY-10 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TAB BIOMERIX CORPORATION 510(k) NO: K093123 (TRADITIONAL)
ATTN: CHRISTINA L KICHULA PHONE NO : 510 933 1222 47757 FREMONT BLVD SE DECISION MADE: 13-MAY-10 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARIAX ELBOW SYSTEM HOWMEDICA OSTEONICS CORP. 510(k) NO: K101056 (TRADITIONAL)
ATTN: MELISSA MATARESE PHONE NO : 201 831 5116 325 CORPORATE DRIVE SE DECISION MADE: 13-MAY-10 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MRI PATIENT POSITIONING DEVICES MEDTEC, INC. 510(k) NO: K093738 (TRADITIONAL)
ATTN: JAMES LEONG PHONE NO : 102 FIRST STREET SOUTH SE DECISION MADE: 14-MAY-10 KALONA IA 52247 9589 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: FREESTYLE LITE BLOOD GLOCUSE TEST STRIPS, MODELS 100 COUNT: 70827-22, 70827-23, 50 COUNT, 70819-20, 70822-22 ABBOTT DIABETES CARE INC. 510(k) NO: K092602 (TRADITIONAL)
ATTN: ARUL STERLIN PHONE NO : 510 864 4310 1360 SOUTH LOOP RD. SE DECISION MADE: 14-MAY-10 ALAMEDA CA 94502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUREFIT DUAL DISPERSIVE ELECTRODE CONMED CORPORATION 510(k) NO: K100047 (SPECIAL)
ATTN: SHAWN RIEDEL PHONE NO : 303 268 8224 14603 E. FREMONT AVE. SE DECISION MADE: 14-MAY-10 CENTENNIAL CO 80112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMART-READ EZTEST-STEAM SCBI AND TEST PACK SGM BIOTECH, INC. 510(k) NO: K093794 (SPECIAL)
ATTN: JOHN R GILLIS, PH.D. PHONE NO : 406 585 9535 10 EVERGREEN DR. SUITE E SE DECISION MADE: 14-MAY-10 BOZEMAN MT 59715 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE NUVASIVE, INC. 510(k) NO: K094054 (SPECIAL)
ATTN: SHEILA BRUSCHI PHONE NO : 858 320 4515 4545 TOWNE CENTRE COURT SE DECISION MADE: 14-MAY-10 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LNCS OXIMETRY SENSORS, REPROCESSED LNCS OXIMETRY SENSORS MASIMO CORPORATION 510(k) NO: K094046 (SPECIAL)
ATTN: MARGUERITE THOMLINSON PHONE NO : 949 297 7258 40 AND 50 PARKER SE DECISION MADE: 14-MAY-10 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES HOWMEDICA OSTEONICS CORP. 510(k) NO: K100271 (TRADITIONAL)
ATTN: MELISSA MATARESE PHONE NO : 201 831 5116 325 CORPORATE DRIVE SE DECISION MADE: 14-MAY-10 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HDL CHOLESTEROL (HDLX) ASSAY BECKMAN COULTER, INC. 510(k) NO: K100010 (TRADITIONAL)
ATTN: YVETTE LLOYD PHONE NO : 714 961 3626 250 S. KRAEMER BOULEVARD MAIL STOPSE DECISION MADE: 14-MAY-10 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE DISETRONIC MEDICAL SYSTEMS AG 510(k) NO: K100704 (SPECIAL)
ATTN: SCOTT THIEL PHONE NO : 317 521 3362 9115 HAGUE ROAD SE DECISION MADE: 14-MAY-10 INDIANAPOLIS IN 46250 0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COCR RODS GLOBUS MEDICAL INC. 510(k) NO: K100788 (SPECIAL)
ATTN: KELLY BAKER PHONE NO : 610 930 1800 2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 14-MAY-10 AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES ZIBO YINGHAO MEDICAL PRODUCTS CO.,510(k) NO: K100294 (TRADITIONAL)
ATTN: FRANK LIU PHONE NO : 909 548 4828 12390 EAST END AVE. SE DECISION MADE: 14-MAY-10 CHINO CA 91710 510(k) STATEMENT DEVICE: COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS MEGO AFEK AC LTD 510(k) NO: K100521 (TRADITIONAL)
ATTN: AVAHA STEIN PHONE NO : 972 976 70002 20 HATA'AS ST. SE DECISION MADE: 14-MAY-10 KFAR SABA IS 44425 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARJET EASYGLIDE LTD. 510(k) NO: K101094 (TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DR. SE DECISION MADE: 17-MAY-10 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HANDHELD PULSE OXIMETER MODEL MD300A/ MD300K2/ MD300M BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K100203 (TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 164 264467 SUITE 5D, NO. 19, LANE 999 ZHONGSHSE DECISION MADE: 17-MAY-10 SHANGHAI CH 20030 510(k) STATEMENT DEVICE: POLARIS SPINAL SYSTEM EBI, L.P. 510(k) NO: K100220 (SPECIAL)
ATTN: SHIKHA GOLA PHONE NO : 973 299 9300 100 INTERPACE PKWY. SE DECISION MADE: 17-MAY-10 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOPEDIATRICS PEDILOC TIBIA PLATE SYSTEM ORTHOPEDIATRICS, CORP. 510(k) NO: K100240 (TRADITIONAL)
ATTN: GARY BARNETT PHONE NO : 574 268 6379 210 N. BUFFALO ST. SE DECISION MADE: 17-MAY-10 WARSAW IN 46580 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROLIFE NON-CONTACT INFRARED FOREHEAD THERMOMETER, MODEL FR1DZ1 MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K100953 (TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949 706 7456 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 17-MAY-10 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FEMEYE TWO FEMSUITE, LLC 510(k) NO: K093218 (TRADITIONAL)
ATTN: PAVAN SETHI PHONE NO : 415 867 9605 19991 7TH STREET EAST SE DECISION MADE: 18-MAY-10 SONOMA CA 95476 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330 INTERSURGICAL, INC. 510(k) NO: K092129 (TRADITIONAL)
ATTN: MICHAEL ZALEWSKI PHONE NO : 315 451 2900 417 ELECTRONICS PKWY. SE DECISION MADE: 18-MAY-10 LIVERPOOL NY 13088 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: T DIAGNOSTIC HYBRIDS, INC. 510(k) NO: K092229 (TRADITIONAL)
ATTN: RONALD H LOLLAR PHONE NO : 740 589 3300 1055 EAST STATE STREET SUITE 100 SE DECISION MADE: 18-MAY-10 ATHENS OH 45701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDO MEDICAL CERAMIC HIP SYSTEM CARDO MEDICAL, INC 510(k) NO: K100008 (TRADITIONAL)
ATTN: DAVE LAMB PHONE NO : 973 777 8832 10 CLIFTON BLVD SUITE B1 SE DECISION MADE: 18-MAY-10 CLIFTON NJ 07011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KENSEY NASH ECM SURGICAL PATCH KENSEY NASH CORPORATION 510(k) NO: K094061 (TRADITIONAL)
ATTN: LORI A BURNS, MS, RAC PHONE NO : 484 713 2100 735 PENNSYLVANIA DRIVE SE DECISION MADE: 18-MAY-10 EXTON PA 19341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OTOMAG OSSEOINTEGRATED BONE CONDUCTION HEARING SYSTEM SOPHONO, INC 510(k) NO: K100193 (TRADITIONAL)
ATTN: MARY ARMSTRONG PHONE NO : 303 223 4336 555 ZANG STREET SUITE 100 SE DECISION MADE: 18-MAY-10 LAKEWOOD CO 80228 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) HUANFU PLASTIC PRODUCTS LIMITED 510(k) NO: K100734 (TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441 ROOM 1606, BLDG 1, JIANXIANG YUAN SE DECISION MADE: 18-MAY-10 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) RAYU PLASTIC PRODUCTS LIMITED 510(k) NO: K100735 (TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441 ROOM 1606 BLDG 1, JIANXIANG YUAN, SE DECISION MADE: 18-MAY-10 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TITAN TI SUTURE ANCHOR SYSTEM, MODELS 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022, 22-9005,, 22-9006 ARTHROCARE CORP. 510(k) NO: K101184 (SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408 736 0224 680 VAQUEROS AVE. SE DECISION MADE: 18-MAY-10 SUNNYVALE CA 94085 3523 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF MEDICREA TECHNOLOGIES 510(k) NO: K083798 (TRADITIONAL)
ATTN: DONALD GUTHNER PHONE NO : 646 460 2984 111 HILL ROAD SE DECISION MADE: 19-MAY-10 DOUGLASSVILLE PA 19518 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVIA CHEMISTRY SALICYLATE REAGENT SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K093939 (TRADITIONAL)
ATTN: KIRA GORDON PHONE NO : 914 524 2996 511 BENEDICT AVENUE SE DECISION MADE: 19-MAY-10 TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE SUCTION AND IRRIGATION SYSTEM MODERN MEDICAL EQUIPMENT MFG., LTD510(k) NO: K093479 (TRADITIONAL)
ATTN: EUGENE YEUNG PHONE NO : 852 242 09068 DONG XING INDUSTRIAL AREA KANG LE SE DECISION MADE: 19-MAY-10 HENG LI, DONGGUAN, GUANGDONG CH510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TERUMO LAUER LOCK ADAPTER TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K093992 (TRADITIONAL)
ATTN: EILEEN DORSEY PHONE NO : 800 283 7866 125 BLUE BALL RD. SE DECISION MADE: 19-MAY-10 ELKTON MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115 MEMOMETAL TECHNOLOGIES 510(k) NO: K093820 (TRADITIONAL)
ATTN: GILLES AUDIC PHONE NO : 332 990 55066 RUE BLAISE PASCAL CAMPUS DE KER LASE DECISION MADE: 19-MAY-10 BRUZ FR F35170 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100 PATHWAY MEDICAL TECHNOLOGIES, INC.510(k) NO: K100462 (TRADITIONAL)
ATTN: BRIT BAIRD PHONE NO : 425 636 4137 10801 120TH AVENUE NE SE DECISION MADE: 19-MAY-10 KIRKLAND WA 98033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) SUZHOU SHENGYUDA PLASTIC PRODUCTS 510(k) NO: K100856 (TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441 ROOM 1606 BUILDING, 1 JIAN XIANG YSE DECISION MADE: 19-MAY-10 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REGENT ANTERIOR CERVICAL PLATE CUSTOM SPINE 510(k) NO: K101151 (SPECIAL)
ATTN: SAAD ATTIYAH PHONE NO : 973 265 5036 1140 PARSIPPANY BLVD, SUITE 20 SE DECISION MADE: 19-MAY-10 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG STAR PLASTIC CO., LTD510(k) NO: K100699 (TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441 ROOM 1606 BLDG.1.JIANXIANG YUAN NOSE DECISION MADE: 20-MAY-10 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROYAL GUARD SHUN THAI RUBBER GLOVES INDUSTRY P510(k) NO: K092617 (TRADITIONAL)
ATTN: KOK-KEE HON PHONE NO : 703 941 7656 6324 MEETING HOUSE WAY SE DECISION MADE: 20-MAY-10 ALEXANDRIA VA 22312 1718 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MANUKAPLI WOUND DRESSING MANUKA MEDICAL LIMITED 510(k) NO: K092689(TRADITIONAL) ATTN: JAMES SMITH PHONE NO : 949 340 7261 29442 POINTE ROYALE SE DECISION MADE: 20-MAY-10 LAGUNA NIGUEL CA 92677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALLY PLATFORM SYSTEM CONTINUITY HEALTH SOLUTIONS 510(k) NO: K093895 (TRADITIONAL)
ATTN: BRIAN POTEET PHONE NO : 866 517 3135 850 NORTH 25TH STREET SE DECISION MADE: 20-MAY-10 OZARK MO 65721 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE NITRILE GLOVES, BLACK HL RUBBER INDUSTRIES SDN BHD 510(k) NO: K100369 (TRADITIONAL)
ATTN: LAU SIONG HUT PHONE NO : 064 811 08788 LOT 10, KAWASAN PERINDUSTRIAN DIOHSE DECISION MADE: 20-MAY-10 KUALA PILAH, NEGERI SEMBILAN MY510(k) STATEMENT DEVICE: KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618 LIFE TECHNOLOGIES CORPORATION 510(k) NO: K100616 (TRADITIONAL)
ATTN: KELLI TANZELLA PHONE NO : 716 774 3122 3175 STALEY ROAD SE DECISION MADE: 20-MAY-10 GRAND ISLAND NY 14072 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FARRELL VALVE WITH CORFLO ANTI-IV CONNECTORS MODEL 20-4300AIV CORPAK MEDSYSTEMS 510(k) NO: K100365 (SPECIAL)
ATTN: STEPHANIE WASIELEWSKI PHONE NO : 847 403 3484 100 CHADDICK DR. SE DECISION MADE: 20-MAY-10 WHEELING IL 60090 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTICAL INTEGRITY LASERGUARD FIBERS OPTICAL INTEGRITY, INC. 510(k) NO: K100194 (TRADITIONAL)
ATTN: RONALD E BOWMAN PHONE NO : 850 233 5512 7500 MCELVEY RD. SE DECISION MADE: 20-MAY-10 PANAMA CITY BEACH FL 32408 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LYMPHA PRESS 201MAX, MODEL 201MAX MEGO AFEK AC LTD 510(k) NO: K100677 (TRADITIONAL)
ATTN: AHAVA STEIN PHONE NO : 972 976 70002 20 HATA'AS ST. SE DECISION MADE: 20-MAY-10 KFAR SABA IS 44425 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENTERAL FEEDING TUBE AND ACCESSORIES, FEEDING TUBE EXTENSION SET ALAN REID 510(k) NO: K092628 (TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DRIVE SE DECISION MADE: 20-MAY-10 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KFX APPIANFX PEEK FEMORAL IMPLANT WITH INSERTER KFX MEDICAL 510(k) NO: K101175 (SPECIAL)
ATTN: GAYLE HIROTA PHONE NO : 760 444 8844 5845 AVENIDA ENCINAS,SUITE 128 SE DECISION MADE: 20-MAY-10 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DESARA MESH MODEL: CAL-DS01 CALDERA MEDICAL, INC. 510(k) NO: K101169 (SPECIAL)
ATTN: VICKI GAIL PHONE NO : 818 879 6555 28632 ROADSIDE DR., SUITE 260 SE DECISION MADE: 20-MAY-10 AGOURA HILLS CA 91301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER JOHNSON & JOHNSON VISION CARE, INC510(k) NO: K100349 (TRADITIONAL)
ATTN: CATHERINE DILLON PHONE NO : 904 443 3180 7500 CENTURION PKWY. SUITE 100 SE DECISION MADE: 21-MAY-10 JACKSONVILLE FL 32256 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONIC SHOT GX NEMOTO KYORINDO CO., LTD. 510(k) NO: K091734 (TRADITIONAL)
ATTN: MASAHIRO SAKAKIBARA PHONE NO : 81 482 503255 2-12-4 AOKI SE DECISION MADE: 21-MAY-10 KAWAGUCHI-SHI, SAITAMA JA 332-0510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAMBO, MODEL CS 18XX-XX ULRICH GMBH & CO. KG 510(k) NO: K090861 (TRADITIONAL)
ATTN: MERLE SYMES PHONE NO : 636 519 0268 754 SPIRIT 40 PARK DRIVE SE DECISION MADE: 21-MAY-10 CHESTERFIELD MO 63005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS INSTRUMENTATION LABORATORY CO. 510(k) NO: K091556 (TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781 861 4467 113 HARTWELL AVE. SE DECISION MADE: 21-MAY-10 LEXINGTON MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK 2 YEAST VORICONAZOLE BIOMERIEUX, INC. 510(k) NO: K092454 (TRADITIONAL)
ATTN: NANCY WEAVER PHONE NO : 314 731 8695 595 ANGLUM RD. SE DECISION MADE: 21-MAY-10 HAZELWOOD MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOMET FORERUNNER LOCKING PLATE SYSTEM BIOMET TRAUMA (AKA EBI, LP) 510(k) NO: K092528 (TRADITIONAL)
ATTN: MARGARET CROWE PHONE NO : 973 299 9300 100 INTERPACE PARKWAY SE DECISION MADE: 21-MAY-10 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANSCORP TRANS-PLATE ANTERIOR CERVICAL PLATE SYSTEM TRANSCORP, INC. 510(k) NO: K092695 (TRADITIONAL)
ATTN: ANDREW RODENHOUSE PHONE NO : 616 877 4177 1000 100TH ST. SW, SUITE F SE DECISION MADE: 21-MAY-10 BYRON CENTER MI 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDIFLASH AND ESTEFLASH DERMEO 510(k) NO: K093168 (TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 888 729 9674 1468 HARWELL AVENUE SE DECISION MADE: 21-MAY-10 CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONMED MACROLYTE DISPERSIVE ELECTRODE CONMED CORPORATION 510(k) NO: K100686 (SPECIAL)
ATTN: SHAWN RIEDEL PHONE NO : 303 268 8224 14603 E. FREMONT AVE. SE DECISION MADE: 21-MAY-10 CENTENNIAL CO 80112 510(k) STATEMENT DEVICE: FIXCET SPINAL FACET SCREW SYSTEM X-SPINE SYSTEMS, INC. 510(k) NO: K100154 (TRADITIONAL)
ATTN: DAVID KIRSCHMAN PHONE NO : 937 847 8400 452 ALEXANDERSVILLE RD. SE DECISION MADE: 21-MAY-10 MIAMISBURG OH 45342 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30 BIOCOMPATIBLES, INC. 510(k) NO: K100847 (TRADITIONAL)
ATTN: WAYNE W RICHARDSON PHONE NO : 203 262 4190 115 HURLEY ROAD SE DECISION MADE: 21-MAY-10 OXFORD CT 06708 510(k) STATEMENT DEVICE: LUMINESSE ZR BLANKS TALLADIUM, INC. 510(k) NO: K100232 (ABBREVIATED)
ATTN: EDWARD HARMS PHONE NO : 661 295 0900 27360 WEST MUIRFIELD LN. SE DECISION MADE: 21-MAY-10 VALENCIA CA 91355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRA DCI MODEL 5000 ULTRASOUND MEDICAL DEVICES, INC. 510(k) NO: K100363 (TRADITIONAL)
ATTN: PAUL KORTESOJA PHONE NO : 734 369 5100 3917 RESEARCH PARK DRIVE SE DECISION MADE: 21-MAY-10 ANN ARBOR MI 48108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNC-RX SYSTEM, MODEL AS00010 SYNC-RX LTD 510(k) NO: K100849 (TRADITIONAL)
ATTN: A ANSELMO PHONE NO : 303 223 4303 555 ZANG ST SUITE 100 SE DECISION MADE: 21-MAY-10 LAKEWOOD CO 80228 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUDIT MICROCV ASO LINEARITY SET, MODEL K721M-5 AALTO SCIENTIFIC LTD. 510(k) NO: K100750 (TRADITIONAL)
ATTN: DESSI LYAKOV PHONE NO : 760 431 7922 1959 KELLOGG AVE. SE DECISION MADE: 21-MAY-10 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054 PENUMBRA, INC. 510(k) NO: K100769 (SPECIAL)
ATTN: MICHAELA MAHL PHONE NO : 510 748 3200 1351 HARBOR BAY PKWY. SE DECISION MADE: 21-MAY-10 ALAMEDA CA 94502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200 SHENZHEN BIOCARE ELECTRONICS CO., 510(k) NO: K100626 (TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 164 684973 SUITE 5D, NO 19, LANE 999 ZHONGSHASE DECISION MADE: 21-MAY-10 SHANGHAI CH 200030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POSTIVA RF THERAPY MODEL 8929 HAND PIECE MEDTRONIC INC. 510(k) NO: K101139 (SPECIAL)
ATTN: THOMAS REICHEL PHONE NO : 763 526 9693 7000 CENTRAL AVENUE NE SE DECISION MADE: 21-MAY-10 MINNEAPOLIS MN 55432 3576 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GUARDIAN II NC HEMOSTASIS VALVE ZERUSA LIMITED 510(k) NO: K101113 (SPECIAL)
ATTN: LIAM MULLOY PHONE NO : 011 353 91863060 219-220 BUSINESS INNOVATION CENTRESE DECISION MADE: 21-MAY-10 GALWAY EI 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVERON 1.0 EARLYSENSE LTD. 510(k) NO: K092062 (TRADITIONAL)
ATTN: DALIA ARGAMAN PHONE NO : 972 375 22330 TZVI 12 SE DECISION MADE: 24-MAY-10 RAMAT-GAN IS 52504 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLYTEL(R) APT MODEL: PWA-08-01 POLYMAP WIRELESS, LLC 510(k) NO: K100524 (ABBREVIATED)
ATTN: PIERRE LANDAU PHONE NO : 520 747 1811 310 S. WILLIAMS BLVD. STE.350 SE DECISION MADE: 24-MAY-10 TUCSON AZ 85711 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 FOCUS DIAGNOSTICS, INC. 510(k) NO: K100148 (TRADITIONAL)
ATTN: TARA VIVIANI PHONE NO : 714 822 2115 11331 VALLEY VIEW ST. SE DECISION MADE: 24-MAY-10 CYPRESS CA 90630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL ABBOTT VASCULAR INC. 510(k) NO: K101011 (SPECIAL)
ATTN: KAY SETZER PHONE NO : 951 914 3242 26531 YNEZ ROAD SE DECISION MADE: 24-MAY-10 TEMECULA CA 92591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MECHANICAL WHEELCHAIR, MODEL DS 202-S SUZHOU KD MEDICAL 510(k) NO: K100824 (TRADITIONAL)
ATTN: JACOB CHANG PHONE NO : 886 422 465396 16F-2 (16A) NO. 462, SEC 2 CHONGDESE DECISION MADE: 25-MAY-10 TAICHUNG TW 406 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT) CRYOLIFE, INC. 510(k) NO: K092021 (TRADITIONAL)
ATTN: JOHN D FERROS PHONE NO : 678 290 4525 1655 ROBERTS BLVD., N.W. SE DECISION MADE: 25-MAY-10 KENNESAW GA 30144 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED "HEALOS" OR "HEALOS II") MODEL 6008, 6025 DEPUY SPINE, INC. 510(k) NO: K093390 (SPECIAL)
ATTN: SHARON STAROWICZ PHONE NO : 508 828 3065 325 PARAMOUNT DR. SE DECISION MADE: 25-MAY-10 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERAMICS2IN1 BIODENTA SWISS AG 510(k) NO: K100150 (TRADITIONAL)
ATTN: DAVID EILER PHONE NO : 417 174 71111 TRAMSTRASSE 16 SE DECISION MADE: 25-MAY-10 BERNECK SZ 9442 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLOOD PRESSURE METER MODEL CH-101 CITIZEN SYSTEMS JAPAN CO., LTD. 510(k) NO: K100553 (TRADITIONAL)
ATTN: NATHAN A BEAVER PHONE NO : 202 295 4039 3000 K STREET NW SUITE 600 SE DECISION MADE: 25-MAY-10 WASHINGTON DC 20007 5143 510(k) STATEMENT DEVICE: PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K093405 (TRADITIONAL)
ATTN: SARAH HOLTGREWE PHONE NO : 901 867 4476 5677 AIRLINE RD. SE DECISION MADE: 25-MAY-10 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVITA NASAL ASPIRATOR, MODEL, NSI SERIES AVITA CORPORATION 510(k) NO: K090379 (TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928 773 6340 2904 N. BOLDT DR. SE DECISION MADE: 26-MAY-10 FLAGSTAFF AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNGO.CT CORONARY ANALYSIS SIEMENS AG, MEDICAL SOLUTIONS 510(k) NO: K100637 (TRADITIONAL)
ATTN: RALF HOFMANN PHONE NO : 49 919 1188170 SIEMENSSTRASSE 1 SE DECISION MADE: 26-MAY-10 FORCHHEIM GM 91301 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM CODMAN & SHURTLEFF, INC. 510(k) NO: K093973 (TRADITIONAL)
ATTN: AMARILYS MACHADO PHONE NO : 786 313 6493 325 PARAMOUNT DR. SE DECISION MADE: 26-MAY-10 RAYNHAM MA 02767 0350 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPRESSIBLE LIMB THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 PLUS) WONJIN MULSAN CO., LTD. 510(k) NO: K100656 (SPECIAL)
ATTN: BRANDON CHOI PHONE NO : 714 523 1592 49 CANDLEWOOD WAY SE DECISION MADE: 26-MAY-10 BUENA PARK CA 90621 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEARTWAY POWER MOBILITY SCOOTER, S11 HEARTWAY MEDICAL PRODUCTS CO., LTD510(k) NO: K101143 (TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829 ROAD 25, NO. 6 TAICHUNG INDUSTRIALSE DECISION MADE: 26-MAY-10 TAICHUNG TW 408 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S34 HEARTWAY MEDICAL PRODUCTS CO., LTD510(k) NO: K101142 (TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829 ROAD 25, NO. 6 TAICHUNG INDUSTRIALSE DECISION MADE: 26-MAY-10 TAICHUNG TW 408 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IQVITALS AND IQVITALS SYSTEM BRENTWOOD MEDICAL TECHNOLOGY CORP.510(k) NO: K100913 (TRADITIONAL)
ATTN: GREG HOLLAND PHONE NO : 949 262 0411 3722 AVE. SAUSALITO SE DECISION MADE: 26-MAY-10 IRVINE CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SELF CATH CATHETER COLOPLAST MANUFACTURING US, LLC 510(k) NO: K100878 (TRADITIONAL)
ATTN: BRIAN SCHMIDT PHONE NO : 612 302 4987 1601 WEST RIVER ROAD SE DECISION MADE: 26-MAY-10 MINNEAPOLIS MN 55411 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: U-RIGHT EAR THEMOMETER, MODELS TD-1115 AND TD-1118 TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K100942 (SPECIAL)
ATTN: NICKY PAN PHONE NO : 886 2 66258188 3F,5F, NO.127 WUGONG 2ND RD. WUGU SE DECISION MADE: 26-MAY-10 TAIPEI COUNTY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB HANDYLAB, INC 510(k) NO: K090191 (TRADITIONAL)
ATTN: MARTHA J RUMFORD PHONE NO : 734 663 4719 5230 S STATE ROAD SE DECISION MADE: 27-MAY-10 ANN ARBOR MI 48108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025 INFOPIA CO., LTD 510(k) NO: K091168 (TRADITIONAL)
ATTN: MARIA F GRIFFIN PHONE NO : 704 843 1675 55 NORTHERN BLVD. SUITE 200 SE DECISION MADE: 27-MAY-10 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAIA, MODEL 1 CENTERVUE SPA 510(k) NO: K092187 (TRADITIONAL)
ATTN: GIULIANO BARBARO PHONE NO : 390 497 811828 VIA TOMMASEO 77 SE DECISION MADE: 27-MAY-10 PADOVA IT 35131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573 FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K093902 (SPECIAL)
ATTN: RANDOLPH QUINN PHONE NO : 781 699 9505 920 WINTER STREET SE DECISION MADE: 27-MAY-10 WALTHAM MA 02451 1457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM 36MM GLENOSPHERE AND HUMERAL LINER EXACTECH, INC. 510(k) NO: K093275 (SPECIAL)
ATTN: LINDY KNISELY PHONE NO : 352 377 1140 2320 N.W. 66TH CT. SE DECISION MADE: 27-MAY-10 GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVATION CROWN CUP GXL LINERS EXACTECH, INC. 510(k) NO: K100269 (SPECIAL)
ATTN: GRAHAM L CUTHBERT PHONE NO : 352 377 1140 2320 N.W. 66TH CT. SE DECISION MADE: 27-MAY-10 GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUSION MEDICAL RING LOCK SYSTEM JOHN J RICCIO 510(k) NO: K100857 (TRADITIONAL)
ATTN: JOHN RICCIO PHONE NO : 203 823 8511 44 CHURCH STREET SE DECISION MADE: 27-MAY-10 WEST HAVEN CT 06516 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-INVASIVE INFRARED (NIR) MEDISIM LTD. 510(k) NO: K090386 (TRADITIONAL)
ATTN: YEVGENIA LIBSTER PHONE NO : 972 2 5791921 G.G. COMMUNICATIONS CENTER SE DECISION MADE: 28-MAY-10 NEVE ILAN IS 90850 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCENAR, MODEL 10 RITM OKB ZAO 510(k) NO: K092117 (TRADITIONAL)
ATTN: LARISA SHPUNGINA PHONE NO : 863 4 623179 99, PETROVSKAYA SE DECISION MADE: 28-MAY-10 TAGANROG RS 347900 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03 ABBOTT MOLECULAR, INC. 510(k) NO: K092704 (TRADITIONAL)
ATTN: PAULA MARTIN PHONE NO : 224 361 7333 1300 EAST TOUHY AVENUE SE DECISION MADE: 28-MAY-10 DES PLAINES IL 60018 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501 ABBOTT MOLECULAR, INC. 510(k) NO: K092705 (TRADITIONAL)
ATTN: PAULA E MARTIN PHONE NO : 224 361 7333 1300 EAST TOUHY AVENUE SE DECISION MADE: 28-MAY-10 DES PLAINES IL 60018 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX COLLAGEN MATRIX, INC. 510(k) NO: K092608 (TRADITIONAL)
ATTN: PEGGY HANSEN PHONE NO : 201 405 1477 509 COMMERCE ST. SE DECISION MADE: 28-MAY-10 FRANKLIN LAKES NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VINYL EXAMINATION GLOVE, POWDER FREE, NON-COLORED QINGDAO LANG HUI IMPORT & EXPORT C510(k) NO: K093264 (TRADITIONAL)
ATTN: MARSHAL MA PHONE NO : 865 328 2972506 SHANDONG INTERNATIONAL TRADE MANSISE DECISION MADE: 28-MAY-10 QINGDAO, SHANDONG CH 266000 510(k) STATEMENT DEVICE: REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER ASCENT HEALTHCARE SOLUTIONS 510(k) NO: K100254 (TRADITIONAL)
ATTN: AMANDA BABCOCK PHONE NO : 480 763 5376 10232 SOUTH 51ST ST. SE DECISION MADE: 28-MAY-10 PHOENIX AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESPIRATORY HUMIDIFIER , HEATED DELIVERY SYSTEM, ADAPTOR, MODELS MR880, RT241, 900MR441 FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K100554 (TRADITIONAL)
ATTN: IVY CHENG PHONE NO : 649 574 0100 15 MAURICE PAYKEL PLACE SE DECISION MADE: 28-MAY-10 EAST TAMAKI NZ 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D; S2-20/20D MASIMO CORPORATION 510(k) NO: K100617 (SPECIAL)
ATTN: MARGUERITE THOMLINSON PHONE NO : 949 297 7000 40 PARKER SE DECISION MADE: 28-MAY-10 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM) OMNLIFE SCIENCE 510(k) NO: K100151 (TRADITIONAL)
ATTN: ROBERT ZOLETTI PHONE NO : 508 824 2444 175 PARAMOUNT DRIVE SE DECISION MADE: 28-MAY-10 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K100427 (TRADITIONAL)
ATTN: TELING HSU PHONE NO : 886 226 6258188 6F, NO. 127, WUGONG 2ND RD WUGU TOSE DECISION MADE: 28-MAY-10 TAIPEI COUNTY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMEDA PLATINUM BREAST PUMP EVENFLO COMPANY, INC. 510(k) NO: K100435 (TRADITIONAL)
ATTN: STEVE NOWAK PHONE NO : 937 415 3347 225 BYERS RD. SE DECISION MADE: 28-MAY-10 MIAMISBURG OH 45342 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VATEA ENDONTIC IRRIGATION SYSTEM REDENT NOVA LTD 510(k) NO: K100606 (TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202 637 5794 COLUMBIA SQUARE 555 13TH STREET, NSE DECISION MADE: 28-MAY-10 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCH BP OFFICE AFIB (TWIN200 AFS). MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K101275 (SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949 706 7456 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 28-MAY-10 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 203 TOTAL WITH SUMMARIES 190 TOTAL WITH STATEMENTS 13
    
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