Medical Devices
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June 2010 510(k) Clearances
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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