Medical Devices
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July 2010 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD July 2010 DEVICE: ANTI-MUTATED CITRULLINATED VIMENTIN EIA ORGENTEC DIAGNOSTIKA GMBH 510(k) NO: K092399(TRADITIONAL) ATTN: GARY LEHNUS PHONE NO : 570 620 0198 150 CHERRY LANE RD. SE DECISION MADE: 01-JUL-10 EAST STROUDSBURG PA 18301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS OLYMPUS WINTER & IBE GMBH 510(k) NO: K100275(TRADITIONAL) ATTN: STACY KLUESNER PHONE NO : 484 896 5405 3500 CORPORATE PKWAY PO BOX 610 SE DECISION MADE: 01-JUL-10 CENTER VALLEY PA 18034 0610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) TANGSHAN ZHONGPU PLASTIC PRODUCTS 510(k) NO: K100059(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 86 10 82387441 ROOM 1606 BLDG 1, JIANXIANG YUAN NSE DECISION MADE: 01-JUL-10 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26 EDWARDS LIFESCIENCES, LLC. 510(k) NO: K093877(TRADITIONAL) ATTN: JASON K LYON PHONE NO : 949 250 3837 ONE EDWARDS WAY SE DECISION MADE: 01-JUL-10 IRVINE CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EARPROBE PATH MEDICAL GMBH 510(k) NO: K100661(TRADITIONAL) ATTN: KURT RENTEL PHONE NO : 970 402 0162 4120 PICADILLY DRIVE SE DECISION MADE: 01-JUL-10 FORT COLLINS CO 80526 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES MATRIX SYSTEM SYNTHES (USA) 510(k) NO: K100634(TRADITIONAL) ATTN: AMNON TALMOR PHONE NO : 610 719 5446 1302 WRIGHTS LANE EAST SE DECISION MADE: 01-JUL-10 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PK SUPERPULSE SYSEM GENERATOR MODEL 744000 GYRUS ACMI, INC. 510(k) NO: K100816(TRADITIONAL) ATTN: GRAHAM A.L. BAILLIE PHONE NO : 508 804 2738 136 TURNPIKE RD. SE DECISION MADE: 01-JUL-10 SOUTHBOROUGH MA 01772 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST PRINCETON BIOMEDITECH CORP. 510(k) NO: K100817(TRADITIONAL) ATTN: JEMO KANG, PH.D. PHONE NO : 732 274 1000 4242 U.S. RT. 1 SE DECISION MADE: 01-JUL-10 MONMOUTH JUNCTION NJ 08852 1905 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TILOCK PEDICLE SCREW SYSTEM GENESYS SPINE 510(k) NO: K100757(TRADITIONAL) ATTN: JOSH KAUFMANN PHONE NO : 512 560 3446 1250 CAPITAL OF TEXAS HWY SO. BUILSE DECISION MADE: 01-JUL-10 AUSTIN TX 78746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IP-SET INTEGRAL PROCESS SAS 510(k) NO: K101685(TRADITIONAL) ATTN: CHRISTIAN BERTHON PHONE NO : 331 397 21177 12 RUE DES CAYENNES PB 310 SE DECISION MADE: 01-JUL-10 CONFLANS SAINTE HONORINE FR 787510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN ETEX CORP. 510(k) NO: K101557(SPECIAL) ATTN: CHRISTOPHER KLACZYK PHONE NO : 617 871 6342 38 SIDNEY ST., 3FLR THE CLARK BLDGSE DECISION MADE: 01-JUL-10 CAMBRIDGE MA 02139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (BLUE, WHITE, PINK) HONG DI PLASTIC PRODUCTS CO., LTD.510(k) NO: K101132(TRADITIONAL) ATTN: JIE LIU PHONE NO : 909 590 1611 3973 SCHAEFER AVE SE DECISION MADE: 01-JUL-10 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES (YELLOW, WHITE,BLUE, PINK) HONGZE PLASTIC TECHNOLOGY CO., LTD510(k) NO: K101135(TRADITIONAL) ATTN: KATHY LIU PHONE NO : 909 287 0357 1930 BREA CANYON RD SE DECISION MADE: 01-JUL-10 DIAMOND BAR CA 91765 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031 EPS BIO TECHNOLOGY CORP. 510(k) NO: K101457(SPECIAL) ATTN: Y.C. LEI PHONE NO : 886 366 86868 NO.8 R&D RD III HSINCHU SCIENCE PASE DECISION MADE: 01-JUL-10 HSINCHU CITY, HSINCHU TW 300 510(k) STATEMENT DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) PT. SMART GLOVE INDONESIA 510(k) NO: K101293(TRADITIONAL) ATTN: CHO S FONG PHONE NO : 626 179 40100 JL RAYA MEDAN-LUBUK PAKAM KM19 TANSE DECISION MADE: 01-JUL-10 MORAWA,DELI SERDANG,SUMATERA U 510(k) STATEMENT DEVICE: SPINESMITH CYNCH SPINAL SYSTEM SPINE SMITH PARTNERS L.P. 510(k) NO: K101085(SPECIAL) ATTN: LAURA LEBOEUF PHONE NO : 512 637 2068 5300 NORTH LAMAR BLVD #107 SE DECISION MADE: 01-JUL-10 AUSTIN TX 78751 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIGHTSTIM ANTI-WRINKLE OTC MODEL AAL OTC LED INTELLECTUAL PROPERTIES, LLC 510(k) NO: K101190(TRADITIONAL) ATTN: ROBERT T WAGNER PHONE NO : 865 982 5552 9832 CHESTERFIELD CIRCLE SE DECISION MADE: 01-JUL-10 SANTA ANA CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCHBP OFFICE TARGET (BP3MD1-4). MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K101512(SPECIAL) ATTN: SUSAN GOLDSTEIN-FALK PHONE NO : 949 706 7456 55 NORTHERN BOULEVARD SUITE 200 SE DECISION MADE: 01-JUL-10 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEV'S INK AUTOCLAVE TAPES NEV'S INK, INC 510(k) NO: K101580(TRADITIONAL) ATTN: DAVE MAROSE PHONE NO : 262 548 0345 2500 W. SUNSET DR SE DECISION MADE: 01-JUL-10 WAUKESHA WI 53189 6326 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: CERULEAU ELECTROSURGICAL PROBE NUORTHO SURGICAL, INC 510(k) NO: K101711(TRADITIONAL) ATTN: MARTIN J LEIGHTON PHONE NO : 603 373 0260 161 LITTLE BAY ROAD SE DECISION MADE: 01-JUL-10 NEWINGTON NH 03801 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GYNECARE TVT ABBREVO CONTINENCE SYSTEM ETHICON, INC. 510(k) NO: K100936(TRADITIONAL) ATTN: SUSAN LIN PHONE NO : 908 218 2256 P.O. BOX 151 ROUTE 22 WEST SE DECISION MADE: 01-JUL-10 SOMERVILLE NJ 08876 0151 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMODILUTION CATHETER BIOSENSORS INTL. PTE. LTD. 510(k) NO: K101669(SPECIAL) ATTN: MOSES THAM PHONE NO : 65 641 10506 21 KALLANG AVENUE #07-165/ 171 SE DECISION MADE: 01-JUL-10 SINGAPORE SN 339412 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELI 250 ELECTROCARDIOGRAPH MORTARA INSTRUMENT, INC. 510(k) NO: K101403(ABBREVIATED) ATTN: CHIEN HUI (AMY) YANG PHONE NO : 414 354 1600 7865 NORTH 86TH ST. SE DECISION MADE: 02-JUL-10 MILWAUKEE WI 53224 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BONE PLUS BCP MEGAGEN IMPLANT CO., LTD 510(k) NO: K090950(TRADITIONAL) ATTN: JOYCE BANG PHONE NO : 562 404 8466 13340 E. FIRESTONE BLVD. SUITE J SE DECISION MADE: 02-JUL-10 SANTA FE SPRINGS CA 90670 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERITS MODEL N SERIES NEBULIZER COMPRESSORS MERITS HEALTH PRODUCTS CO., LTD. 510(k) NO: K092859(ABBREVIATED) ATTN: STEVE CHAO PHONE NO : 886 423 594985 9, ROAD 36 TAICHUNG INDUSTRIAL PARSE DECISION MADE: 02-JUL-10 TAICHUNG TW 407 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KMD-MARK1 TISSUE MARKER KENT MEDICAL DEVICES, INC. 510(k) NO: K093473(TRADITIONAL) ATTN: JUSTIN EGGLETON PHONE NO : 202 552 5800 1331 H STREET NW 12TH FLOOR SE DECISION MADE: 02-JUL-10 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACTIPROTECT UC N95 RESPIRATOR GLAXOSMITHKLINE CONSUMER HEALTHCAR510(k) NO: K093189(ABBREVIATED) ATTN: ZINATARA MANJI PHONE NO : 973 889 2322 1500 LITTLETON RD. SE DECISION MADE: 02-JUL-10 PARSIPPANY NJ 07054 3884 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDLINE PVC URETHRAL CATHETER MEDLINE INDUSTRIES, INC. 510(k) NO: K100302(TRADITIONAL) ATTN: MATT CLAUSEN PHONE NO : 847 643 4785 ONE MEDLINE PLACE SE DECISION MADE: 02-JUL-10 MUNDELEIN IL 60060 510(k) STATEMENT DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR , MODEL KN-550 HARVARD MEDICAL DEVICES LTD. 510(k) NO: K100620(TRADITIONAL) ATTN: MARTIN MA PHONE NO : 852 273 20971 39 CHATHAM ROAD SOUTH SE DECISION MADE: 02-JUL-10 TSIMSHATSUI, KOWLOON HK 510(k) STATEMENT DEVICE: CHEETAH NICOM SYSTEM CHEETAH MEDICAL INC. 510(k) NO: K101487(ABBREVIATED) ATTN: RHONA SHANKER PHONE NO : 301 251 9570 12154 DARNESTOWN RD. #236 SE DECISION MADE: 02-JUL-10 GAITHERSBURG MD 20878 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL REFERENCE TOOL (PRT) ST. JUDE MEDICAL 510(k) NO: K101667(SPECIAL) ATTN: DONNA R LUNAK PHONE NO : 651 756 2944 ONE ST. JUDE MEDICAL DRIVE SE DECISION MADE: 02-JUL-10 ST. PAUL MN 55117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MISTRAL-AIR WORMING SYSTEM THE SURGICAL COMPANY INTERNATIONAL510(k) NO: K101705(TRADITIONAL) ATTN: ADRIAAN P INTVELD PHONE NO : 313 345 07266 3821 AH AMERSFOORT SE DECISION MADE: 02-JUL-10 BEELDSCHERMWEG 6G NL 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PROTOE ENDOSORB SMALL HAMMER TOE PIN MERETE MEDICAL GMBH 510(k) NO: K100414(TRADITIONAL) ATTN: EMMANUEL ANAPLIOTIS PHONE NO : 914 967 1532 ALT LANKWITZ 102 SE DECISION MADE: 02-JUL-10 BERLIN GM 12247 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVIS EXERAII 180 SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K100584(TRADITIONAL) ATTN: STACY A KLUESNER PHONE NO : 484 896 5405 REGULATORY AFFAIRS & QUALITY 3500 SE DECISION MADE: 02-JUL-10 CENTER VALLEY PA 18034 0610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DSS STABILIZATION SYSTEM PARADIGM SPINE LLC 510(k) NO: K101083(SPECIAL) ATTN: MICHELLE MCDONOUGH PHONE NO : 202 552 5800 1331 H STREET NW 12TH FLOOR SE DECISION MADE: 02-JUL-10 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MD VISION SYSTEM PERKINS HEALTHCARE TECHNOLOGIES 510(k) NO: K101474(TRADITIONAL) ATTN: ANDREW C KYLE PHONE NO : 214 828 4545 700 INTERNATIONAL PKWAY SE DECISION MADE: 02-JUL-10 RICHARDSON TX 75081 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR WHITE, NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR BLUE JIANGSU SUNSHINE PLASTIC PRODUCTS,510(k) NO: K100979(TRADITIONAL) ATTN: MICHAEL LEE PHONE NO : 886 228 096995 NO.45 MINSHENG RD, DANSHUI TWN SE DECISION MADE: 02-JUL-10 TAIPEI COUNTY TW 251 510(k) STATEMENT DEVICE: LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727 ROCHE MOLECULAR SYSTEMS, INC. 510(k) NO: K091409(TRADITIONAL) ATTN: LARRY PIETRELLI PHONE NO : 925 730 8040 4300 HACIENDA DR. SE DECISION MADE: 06-JUL-10 PLEASANTON CA 94588 2722 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG BIOMERIEUX, INC. 510(k) NO: K093383(TRADITIONAL) ATTN: MARIA OYASKI PHONE NO : 919 620 2270 100 RODOLPHE ST SE DECISION MADE: 06-JUL-10 DURHAM NC 27712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136 U.S. ARMY MEDICAL MATERIAL DEVELOP510(k) NO: K100287(TRADITIONAL) ATTN: ROBERT E MILLER PHONE NO : 301 619 0317 1430 VETERANS DRIVE SE DECISION MADE: 06-JUL-10 FORT DETRICK MD 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM ZEUS SCIENTIFIC, INC. 510(k) NO: K100728(TRADITIONAL) ATTN: EWA NADOLCZAK PHONE NO : 908 526 3744 200 EVANS WAY SE DECISION MADE: 06-JUL-10 BRANCHBURG NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K101195(TRADITIONAL) ATTN: BERNICE LIN PHONE NO : 408 732 3856 670 ALMANOR AVE SE DECISION MADE: 06-JUL-10 SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP) ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K100051(ABBREVIATED) ATTN: NASISHU WANG PHONE NO : 858 513 3888 13200 GREGG ST. SE DECISION MADE: 06-JUL-10 POWAY CA 92064 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-CONTACT FOREHEAD INFRARED THERMOMETER, MODEL DT-8806H, BODY INFRARED THERMOMETER, MODEL DT-8806 AND DIGITAL INFRARED SHENZHEN EVERBEST MACHINERY INDUST510(k) NO: K101736(TRADITIONAL) ATTN: DENG AIGUO PHONE NO : 86 755 27353188 19TH BUILDING, 5TH REGION BAIWANGXSE DECISION MADE: 06-JUL-10 BAIMANG XILI NANSHAN SHENZHEN C510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: XYLOS VESSEL GUARD XYLOS CORPORATION 510(k) NO: K100984(TRADITIONAL) ATTN: JOYCE ELKINS PHONE NO : 215 867 0220 838 TOWN CENTER DR. SE DECISION MADE: 07-JUL-10 LANGHORNE PA 19047 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDO MEDICAL FEMORAL CEMENT RESTRICTOR, MODEL 503-MCRX CARDO MEDICAL, INC 510(k) NO: K101032(TRADITIONAL) ATTN: MICHAEL KVITNITSKY PHONE NO : 973 777 8832 10 CLIFTON BLVD SUITE B1 SE DECISION MADE: 08-JUL-10 CLIFTON NJ 07011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) TANGSHAN KANGYUAN GLOVE CO., LTD. 510(k) NO: K100057(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 86 10 82387441 RM 1606 BLDG. 1. JIANXING YUAN NO.SE DECISION MADE: 08-JUL-10 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZYNO Z-800 INFUSION SYSTEM MODEL Z-800 ZYNO MEDICAL LLC 510(k) NO: K100705(ABBREVIATED) ATTN: CHAOYOUNG LEE PHONE NO : 781 895 1980 395 TOTTEN POND RD. SUITE 201 SE DECISION MADE: 08-JUL-10 WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT RIVERPOINT MEDICAL 510(k) NO: K100461(ABBREVIATED) ATTN: DOUG ROWLEY PHONE NO : 503 517 8001 825 NE 25TH AVE. SE DECISION MADE: 08-JUL-10 PORTLAND OR 97232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISUMAX LASER KERATOME CARL ZEISS MEDITEC AG 510(k) NO: K100253(TRADITIONAL) ATTN: JUDITH A BRIMACOMBE PHONE NO : 925 557 4616 5160 HACIENDA DRIVE SE DECISION MADE: 08-JUL-10 DUBLIN CA 94568 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: IMPELLA CONTROLLER ABIOMED, INC. 510(k) NO: K093801(TRADITIONAL) ATTN: ROBERT STEWART PHONE NO : 978 646 1567 22 CHERRY HILL DR. SE DECISION MADE: 08-JUL-10 DANVERS MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HI-TORQUE WINN GUIDE WIRE FAMILY ABBOTT VASCULAR INC. 510(k) NO: K101648(SPECIAL) ATTN: LAARNI RICAFORT PHONE NO : 408 845 0688 3200 LAKESIDE DRIVE SE DECISION MADE: 08-JUL-10 SANTA CLARA CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO:RADIUS SPINAL SYSTEM STRYKER SPINE 510(k) NO: K101144(SPECIAL) ATTN: CURTIS TRUESDALE PHONE NO : 201 760 8296 2 PEARL COURT SE DECISION MADE: 08-JUL-10 ALLENDALE NJ 07401 1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERACLEAR THERAVANT CORPORATION 510(k) NO: K101415(TRADITIONAL) ATTN: MARCY MOORE PHONE NO : 919 363 2432 131 KELEKENT LANE SE DECISION MADE: 08-JUL-10 CARY NC 27518 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEM SIESTA MEDICAL, INC. 510(k) NO: K101060(TRADITIONAL) ATTN: MICHAEL KOLBER PHONE NO : 408 505 6626 101 CHURCH STREET SUITE 3 SE DECISION MADE: 08-JUL-10 LOS GATOS CA 95030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HM-LAMP II HILLUSA, INC. 510(k) NO: K100234(TRADITIONAL) ATTN: MARIA GUMA PHONE NO : 305 594 7474 7215 N.W. 46TH ST. SE DECISION MADE: 08-JUL-10 MIAMI FL 33166 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM A-DEC, INC. 510(k) NO: K100647(TRADITIONAL) ATTN: THOMAS H LOUISELL PHONE NO : 503 538 9471 2601 CRESTVIEW DR. SE DECISION MADE: 09-JUL-10 NEWBERG OR 97132 9257 510(k) STATEMENT DEVICE: SECURACATH UNIVERSAL INTERRAD MEDICAL, INC. 510(k) NO: K092306(TRADITIONAL) ATTN: JONATHAN KAHAN PHONE NO : 202 637 5794 555 13TH STREET NW SE DECISION MADE: 09-JUL-10 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIHON KOHDEN QP-160AK EEG TREND PROGRAM NIHON KOHDEN AMERICA, INC. 510(k) NO: K092573(TRADITIONAL) ATTN: STEVE GEERDES PHONE NO : 949 580 1555 90 ICON ST. SE DECISION MADE: 09-JUL-10 FOOTHILL RANCH CA 92610 1601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COTEC DENTAL IMPLANT SYSTEM COTEC IMPLANT CO., LTD. 510(k) NO: K100511(TRADITIONAL) ATTN: JOYCE BANG PHONE NO : 562 404 8466 13340 FIRESTONE BLVD. SUITE J SE DECISION MADE: 09-JUL-10 SANTA FE SPRINGS CA 90670 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROSTHODONTIC SCREWDRIVER , MODEL IA-400 W & H DENTALWERK BUERMOOS GMBH 510(k) NO: K100600(TRADITIONAL) ATTN: JOHANN G SCHARL PHONE NO : 436 274 6236297 53 IGNAZ-GLASER-STRASSE SE DECISION MADE: 09-JUL-10 BUERMOOS AU 5111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS MEDTRONIC MINIMED 510(k) NO: K100432(TRADITIONAL) ATTN: MARK FAILLACE PHONE NO : 818 362 5958 18000 DEVONSHIRE ST. SE DECISION MADE: 09-JUL-10 NORTHRIDGE CA 91325 1219 510(k) STATEMENT DEVICE: FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K100405(SPECIAL) ATTN: NICKY PAN PHONE NO : 886 266 258188 3F,5F, NO.127 WUGONG 2ND RD. WUGU SE DECISION MADE: 09-JUL-10 TAIPEI COUNTY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920 MERIDIAN BIOSCIENCE, INC. 510(k) NO: K100818(TRADITIONAL) ATTN: MICHELLE L SMITH PHONE NO : 513 271 3700 3471 RIVER HILLS DR. SE DECISION MADE: 09-JUL-10 CINCINNATI OH 45244 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER MASIMO CORPORATION 510(k) NO: K100428(TRADITIONAL) ATTN: MARGUERITE THOMLINSON PHONE NO : 949 297 7258 40 PARKER SE DECISION MADE: 09-JUL-10 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MD2000B VITAL SIGN MONITOR, MODEL MD2000B BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K100740(TRADITIONAL) ATTN: DIANG HONG PHONE NO : 862 164 264467 SUITE 8D ZHONGXIN ZHONGSHAN MANSIOSE DECISION MADE: 09-JUL-10 SHANGHAI, SHANGHAI CH 20020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: U-RIGHT TD-3127 BLOOD PRESSURE MONITORING SYSTEM TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K100658(SPECIAL) ATTN: NICKY PAN PHONE NO : 886 266 258188 3F, 5F, NO 127 WUGONG 2ND RD WUGU SE DECISION MADE: 09-JUL-10 TAIPEI COUNTY TW 248 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPONDYLOS SPINAL FIXATION SYSTEM ALLURE SPINE L.L.C. 510(k) NO: K100956(TRADITIONAL) ATTN: JULIA ELLER PHONE NO : 440 339 8709 9214 SANDPIPER DRIVE SE DECISION MADE: 09-JUL-10 CHARLOTTE NC 28277 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORA G30A BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241 TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K100732(SPECIAL) ATTN: NICKY PAN PHONE NO : 886 266 258188 3F, 5F, NO 127 WUGONG 2ND RD WUGU SE DECISION MADE: 09-JUL-10 TAIPEI COUNTY TW 248 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM GALIX BIOMEDICAL INSTRUMENTATION, 510(k) NO: K092853(TRADITIONAL) ATTN: YOEL PALOMINO PHONE NO : 305 534 5905 2555 COLLINS AVE., C-5 SE DECISION MADE: 09-JUL-10 MIAMI BEACH FL 33140 510(k) STATEMENT DEVICE: NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL SIAM SEMPERMED CORP. LTD. 510(k) NO: K100907(ABBREVIATED) ATTN: WILLIAM HARRIS PHONE NO : 727 787 7250 13900 49TH STREET NORTH SE DECISION MADE: 09-JUL-10 CLEARWATER FL 33762 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENOFER PUMP RENAL SOLUTIONS INC. 510(k) NO: K093964(ABBREVIATED) ATTN: DAVID VANELLA PHONE NO : 724 720 2840 770 COMMONWEALTH DRIVE SUITE 101 SE DECISION MADE: 09-JUL-10 WARRENDALE PA 15086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECLERIS MICROSTAR COLPOSCOPE ECLERIS USA 510(k) NO: K100595(TRADITIONAL) ATTN: HENRY SAND PHONE NO : 866 960 9756 12225 WORLD TRADE DRIVE SUITE K SE DECISION MADE: 09-JUL-10 SAN DIEGO CA 92128 510(k) STATEMENT DEVICE: WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES WELCH ALLYN, INC. 510(k) NO: K101680(SPECIAL) ATTN: HUY DOAN PHONE NO : 315 554 4001 4341 STATE ST. RD. P.O. BOX 220 SE DECISION MADE: 09-JUL-10 SKANEATELES FALLS NY 13153 0220 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE CORDIS CORP. 510(k) NO: K101651(SPECIAL) ATTN: JOAN MARTIN PHONE NO : 908 541 4888 430 ROUTE 22 EAST SE DECISION MADE: 09-JUL-10 BRIDGEWATER NJ 08807 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PULMOTRACK 5050 WHOLTER, MODEL 5050 KARMELSONIX 510(k) NO: K101022(TRADITIONAL) ATTN: YORAM LEVY PHONE NO : 972 463 88837 31 HAAVODA ST. SE DECISION MADE: 09-JUL-10 BINYAMINA IS 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD DIRECTIGEN EZ RSV BECTON DICKINSON & CO. 510(k) NO: K101514(TRADITIONAL) ATTN: GREGORY P PAYNE PHONE NO : 858 795 7890 11085 NORTH TORREY PINES RD SUITE SE DECISION MADE: 09-JUL-10 LA JOLLA CA 92037 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIL 1520 GLENN MEDICAL SYSTEMS, INC. 510(k) NO: K101629(TRADITIONAL) ATTN: GARY CLEVINGER PHONE NO : 330 453 1177 511 12TH STREET, N.E. SE DECISION MADE: 09-JUL-10 NE CANTON OH 44704 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: LOCI 8 CALIBRATOR, MODEL KC 646 SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K101460(ABBREVIATED) ATTN: ANNA MARIE ENNIS PHONE NO : 302 631 9352 500 GBC DRIVE PO BOX 6101 SE DECISION MADE: 09-JUL-10 NEWARK DE 19714 6101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLAVE NEUTRON ICU MEDICAL, INC. 510(k) NO: K100434(TRADITIONAL) ATTN: TRACY BEST PHONE NO : 801 264 1332 4455 ATHERTON DRIVE SE DECISION MADE: 09-JUL-10 SALT LAKE CITY UT 84123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE OMEGA LABORATORIES, INC. 510(k) NO: K101059(TRADITIONAL) ATTN: ROBERT J BARD PHONE NO : 248 563 5040 PO BOX 506 SE DECISION MADE: 12-JUL-10 SOUTH LYON MI 48178 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPROVACUTER GEL & CLOT ACTIVATOR TUBE GUANGZHOU IMPROBE MEDICAL INSTRUME510(k) NO: K093910(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 862 164 264467 SUITE D NO.19, LANE 999 ZHONGSHAN SE DECISION MADE: 12-JUL-10 SHANGHAI CH 20030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM HOTSPUR TECHNOLOGIES 510(k) NO: K100842(TRADITIONAL) ATTN: ERIC ANKERUD PHONE NO : 978 302 9467 880 MAUDE AVENUE SUITE A SE DECISION MADE: 12-JUL-10 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMBO PLUS EMBOLECTOMY CATHETER HOTSPUR TECHNOLOGIES 510(k) NO: K100840(TRADITIONAL) ATTN: ERIC ANKERUD PHONE NO : 978 302 9467 880 MAUDE AVENUE SUITE A SE DECISION MADE: 12-JUL-10 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARIAN TREATMENT VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K093967(TRADITIONAL) ATTN: VY TRAN PHONE NO : 650 842 5040 3100 HANSEN WAY M/S E-110 SE DECISION MADE: 12-JUL-10 PALO ALTO CA 94304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASCENSION ANKLE FUSION NAIL SYSTEM ASCENSION ORTHOPEDICS, INC. 510(k) NO: K100925(TRADITIONAL) ATTN: DEBBIE STEARNS PHONE NO : 512 836 5001 8700 CAMERON RD., STE. 100 SE DECISION MADE: 12-JUL-10 AUSTIN TX 78754 3832 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAVI PREPARATION DEVICE CIANNA MEDICAL, INC. 510(k) NO: K101411(TRADITIONAL) ATTN: GARY MOCNIK PHONE NO : 949 360 0059 6 JOURNEY SUITE 125 SE DECISION MADE: 12-JUL-10 ALISO VIEJO CA 92656 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PENUMBRA CATHERER 025 PENUMBRA, INC. 510(k) NO: K100826(TRADITIONAL) ATTN: SETH A SCHULMAN PHONE NO : 510 748 3200 1351 HARBOR BAY PKWY. SE DECISION MADE: 13-JUL-10 ALAMEDA CA 94502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM ANDON MEDICAL CO., LTD. 510(k) NO: K093262(TRADITIONAL) ATTN: YI LIU PHONE NO : 862 260 526161 NANKAI DISTRICT SE DECISION MADE: 13-JUL-10 TIANJIN CH 300190 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL 300157 CPAP SYSTEM AEIOMED, INC. 510(k) NO: K100121(ABBREVIATED) ATTN: DARIN BUSCH PHONE NO : 612 455 0550 1313 5TH STREET SE, STE 205 SE DECISION MADE: 13-JUL-10 MINNEAPOLIS MN 55414 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT COCHLEAR AMERICAS 510(k) NO: K100360(TRADITIONAL) ATTN: SEAN BUNDY PHONE NO : 800 523 5798 13059 E PEAKVIEW AVE SE DECISION MADE: 13-JUL-10 CENTENNIAL CO 80111 510(k) STATEMENT DEVICE: VARIAN HIGH ENERGY LINEAR ACCELERATOR VARIAN MEDICAL SYSTEMS 510(k) NO: K100890(SPECIAL) ATTN: VY TRAN PHONE NO : 650 424 5731 3100 HANSEN WAY M/S E-110 SE DECISION MADE: 13-JUL-10 PALO ALTO CA 94304 1129 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084 CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K101703(SPECIAL) ATTN: CLAY ANESELMO PHONE NO : 303 223 4303 555 ZANG STREET SUITE 100 SE DECISION MADE: 13-JUL-10 LAKEWOOD CO 80228 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE VENNER MEDICAL (SINGAPORE) PTE LTD510(k) NO: K100950(TRADITIONAL) ATTN: JUDY BURTON PHONE NO : 972 243 5105 2626 VALLEY VIEW LANE, SUITE 4 SE DECISION MADE: 13-JUL-10 DALLAS TX 75234 510(k) STATEMENT DEVICE: HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS MICRO THERAPEUTICS DBA EV3 NEUROVA510(k) NO: K101570(TRADITIONAL) ATTN: LAURIE CARTWRIGHT PHONE NO : 949 680 1317 9775 TOLEDO WAY SE DECISION MADE: 13-JUL-10 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PTA-DUO PTA BALLOON CATHETER HOTSPUR TECHNOLOGIES 510(k) NO: K101047(TRADITIONAL) ATTN: ERIC P ANKERUD PHONE NO : 978 302 9467 880 MAUDE AVENUE SUITE A SE DECISION MADE: 13-JUL-10 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE REFLECTIVE MARKER SPHERES BRAINLAB, AG 510(k) NO: K100038(TRADITIONAL) ATTN: ALEXANDER SCHWIERSCH PHONE NO : 498 999 15680 KAPELLENSTRASSE 12 SE DECISION MADE: 14-JUL-10 FELDKIRCHEN GM 85622 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMPLISSE ELECTRIC BREASTFEEDING COMPANION SIMPLISSE INC. 510(k) NO: K093648(TRADITIONAL) ATTN: GLEN FEYE PHONE NO : 619 517 1762 1340 WEST PENNSYLVANIA AVE SE DECISION MADE: 14-JUL-10 SAN DIEGO CA 92103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDICAL SURGICAL MASK (HH1001), RESPIRATORY MASK (HH1002) H&H RESEARCH COMPANY 510(k) NO: K093179(ABBREVIATED) ATTN: JONG HUANG PHONE NO : 213 977 1257 1245 WILSHIRE BLVD. #501 SE DECISION MADE: 14-JUL-10 LOS ANGELES CA 90017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OLYMPUS CF TYPE Y0023-L, Y0023I OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K101053(TRADITIONAL) ATTN: STACY A KLUESNER PHONE NO : 484 896 5405 REGULATORY AFFAIRS & QUALITY 3500 SE DECISION MADE: 14-JUL-10 CENTER VALLEY PA 18034 0610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENSITE VELOCITY SYSTEM ST. JUDE MEDICAL 510(k) NO: K101328(SPECIAL) ATTN: DONNA R LUNAK PHONE NO : 651 756 2944 ONE ST. JUDE MEDICAL DRIVE SE DECISION MADE: 14-JUL-10 ST. PAUL MN 55117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AESCULAP MONOMAX ABSORBABLE SUTURE AESCULAP, INC. 510(k) NO: K100876(TRADITIONAL) ATTN: KATHY A RACOSKY PHONE NO : 610 984 9291 3773 CORPORATE PARKWAY SE DECISION MADE: 14-JUL-10 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY ANGIOSCORE, INC. 510(k) NO: K101735(SPECIAL) ATTN: KIMBERLEY KLINE PHONE NO : 510 933 7989 5055 BRANDIN COURT SE DECISION MADE: 14-JUL-10 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701 SHANGHAI CHENGUANG MEDICAL TECHNOL510(k) NO: K101858(TRADITIONAL) ATTN: JIE HUANG PHONE NO : 862 152 961075 BLDG 8, LANE 1199, JIDI ROAD SE DECISION MADE: 14-JUL-10 SHANGHAI CH 201107 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: REMEL SPECTRA VRE THERMO FISHER SCIENTIFIC 510(k) NO: K092819(TRADITIONAL) ATTN: MARY ANN SILVIUS PHONE NO : 913 895 4054 12150 SANTA FE DRIVE SE DECISION MADE: 15-JUL-10 LENEXA KS 66215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTOS LIMITED PANORAMIC 200CAF OPTOS PLC 510(k) NO: K100644(TRADITIONAL) ATTN: HOWARD M HOLSTEIN PHONE NO : 202 637 5815 555 THIRTEENTH ST. N.W. COLUMBIA SSE DECISION MADE: 15-JUL-10 WASHINGTON DC 20004 1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: YEAST TRAFFIC LIGHT PNA FISH ADVANDX, INC. 510(k) NO: K093024(TRADITIONAL) ATTN: HENRIK STENDER PHONE NO : 781 376 0009 400 TRADECENTER SUITE 6990 SE DECISION MADE: 15-JUL-10 WOBURN MA 01801 510(k) STATEMENT DEVICE: THD BANDY THD SPA 510(k) NO: K093497(TRADITIONAL) ATTN: GUIDO BONAPACE PHONE NO : 393 355 378686 VIA BORGO SANTA CRISTINA 12 SE DECISION MADE: 15-JUL-10 IMOLA, BO IT 40026 510(k) STATEMENT DEVICE: ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC GENESEE BIOMEDICAL, INC. 510(k) NO: K093903(SPECIAL) ATTN: JOHN T.M. WRIGHT PHONE NO : 303 777 3000 1308 SOUTH JASON ST. SE DECISION MADE: 15-JUL-10 DENVER CO 80223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVGUIDE TIP LOCATION SYSTEM ROMEDEX INTERNATIONAL SRL 510(k) NO: K093775(TRADITIONAL) ATTN: SORIN GRUNWALD PHONE NO : 650 209 4838 175 COLORADO AVENUE SE DECISION MADE: 15-JUL-10 PALO ALTO CA 94303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1 WELLDOC, INC 510(k) NO: K100066(TRADITIONAL) ATTN: MALINDA PEEPLES PHONE NO : 443 692 3101 1501 SAINT PAUL STREET SUITE 118 SE DECISION MADE: 15-JUL-10 BALTIMORE MD 21202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW MDF MODULAR SLEEVE SMITH & NEPHEW, INC. 510(k) NO: K100481(ABBREVIATED) ATTN: NATALIE P WILLIAMS PHONE NO : 901 399 5161 1450 BROOKS RD. SE DECISION MADE: 15-JUL-10 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XINIWAVE, MODEL XW-18 INTERNATIONAL TRADE GROUP, INC. 510(k) NO: K100441(TRADITIONAL) ATTN: BRENT C REIDER PHONE NO : 614 568 7000 4663 KATIE LN. SE DECISION MADE: 15-JUL-10 OXFORD OH 45056 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE SURGICAL INNOVATIONS PLC 510(k) NO: K100109(TRADITIONAL) ATTN: MIKE WHITE PHONE NO : 440 113 2307597 CLAYTON PARK CLAYTON WOOD RISE SE DECISION MADE: 15-JUL-10 LEEDS UK LS16 6RF 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLAT PANEL DETECTOR, MODEL FDR D-EVO FUJIFILM MEDICAL SYSTEMS U.S.A., I510(k) NO: K100762(TRADITIONAL) ATTN: DEBBIE PEACOCK PHONE NO : 203 602 3774 419 WEST AVE. SE DECISION MADE: 15-JUL-10 STAMFORD CT 06902 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DENTLIGHT ORAL EXAM LIGHT KIT DENTLIGHT INC. 510(k) NO: K101140(TRADITIONAL) ATTN: RICHARD LIU PHONE NO : 972 889 8857 1411 E. CAMPBELL RD SUITE 500 SE DECISION MADE: 15-JUL-10 RICHARDSON TX 75081 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM TECNOLOGIA Y DISENO INDUSTRIAL, S.510(k) NO: K101254(TRADITIONAL) ATTN: ROBERT J BARD, JD PHONE NO : 248 573 5040 PO BOX 506 SE DECISION MADE: 15-JUL-10 SOUTH LYON MI 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FACET SCREW SYSTEM NUVASIVE, INC. 510(k) NO: K101284(TRADITIONAL) ATTN: SHEILA BRUSCHI PHONE NO : 858 320 4515 7475 LUSK BLVD SE DECISION MADE: 15-JUL-10 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEOTRACT ANCHOR SYSTEM MODEL: REF 11208 NEOTRACT, INC. 510(k) NO: K101252(TRADITIONAL) ATTN: KEVIN MACDONALD PHONE NO : 415 609 9875 4473 WILLOW ROAD SUITE 100 SE DECISION MADE: 15-JUL-10 PLEASANTON CA 94588 510(k) STATEMENT DEVICE: VIVATRAK WIRELESS MEDCARE, LLC 510(k) NO: K101109(TRADITIONAL) ATTN: PAUL SUMNER PHONE NO : 770 448 7529 1733 CANTON LANE SE DECISION MADE: 15-JUL-10 MARIETTA GA 30062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PACSMATE MMD-5201M MONITOR IEI TECHNOLOGY CORP. 510(k) NO: K101796(TRADITIONAL) ATTN: HUI-CHEN KAI PHONE NO : 886 3 3280026 #6, LANE 29, WENMING ROAD SE DECISION MADE: 15-JUL-10 GUISHAN, TAOYUAN TW 33383 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: VENTRALIGHT ST MESH DAVOL INC., SUB. C.R. BARD, INC. 510(k) NO: K101851(SPECIAL) ATTN: MICHELLE GODIN PHONE NO : 401 825 8589 100 CROSSINGS BLVD SE DECISION MADE: 15-JUL-10 WARWICK RI 02886 510(k) STATEMENT DEVICE: ASTRASONIC SPIROMETER, MODEL 29-8000 SDI DIAGNOSTICS, INC. 510(k) NO: K092813(TRADITIONAL) ATTN: COSIMO CARIOLO PHONE NO : 508 238 7033 10 HAMPDEN DR. SE DECISION MADE: 16-JUL-10 EASTON MA 02375 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000 MEDIVANCE, INC. 510(k) NO: K101092(TRADITIONAL) ATTN: LYNNE ARONSON PHONE NO : 303 926 1917 321 SOUTH TAYLOR AVE, STE 200 SE DECISION MADE: 16-JUL-10 LOUISVILLE CO 80027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE MODEL: MSP1 BEST PUTRA GLOVES SDN BHD 510(k) NO: K101103(TRADITIONAL) ATTN: EFFENDI TENANG PHONE NO : 036 092 1042 MOHD TAIB, KAWASAN PERINDUSTRIAN SE DECISION MADE: 16-JUL-10 SG CHOH RAWANG, SELANGOR MY 480510(k) STATEMENT DEVICE: POWDER-FREE, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE BEST PUTRA GLOVES SDN BHD 510(k) NO: K101102(TRADITIONAL) ATTN: EFFENDI TENANG PHONE NO : 360 921 01042 MOHD TAIB, KAWASAN PERINDUSTRIAN SE DECISION MADE: 16-JUL-10 SG CHOH RAWANG, SELANGOR MY 480510(k) STATEMENT DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) HEBEI SHENZICHEN PLASTIC & RUBBER 510(k) NO: K100964(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 86 10 82387441 209 BEI SI HUAN ZHONG RD HAI D RM SE DECISION MADE: 16-JUL-10 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM TRANSAMERICAN MEDICAL IMAGING 510(k) NO: K092713(TRADITIONAL) ATTN: ROBERT H WOODWARD PHONE NO : 801 796 7363 965 WEST 325 NORTH SE DECISION MADE: 16-JUL-10 LINDON UT 84042 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM ZEUS SCIENTIFIC, INC. 510(k) NO: K093784(TRADITIONAL) ATTN: EWA NADOLCZAK PHONE NO : 609 408 1331 P.O. BOX 38 SE DECISION MADE: 16-JUL-10 RARITAN NJ 08869 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LASEMAR 800, 1000, 1500 EUFOTON S.R.L. 510(k) NO: K092860(TRADITIONAL) ATTN: PAOLO COSSICH PHONE NO : 393 491 536476 VIA FLAVIA 23/1 SE DECISION MADE: 16-JUL-10 TRIESTE IT 34148 510(k) STATEMENT DEVICE: RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) RIVERSTONE RESOURCES SDN. BHD. 510(k) NO: K100603(TRADITIONAL) ATTN: CHONG CHU MEE PHONE NO : 603 602 83033 JALAN JASMIN 2 48300 BUKIT BERUNTUSE DECISION MADE: 16-JUL-10 SELANGOR MY 48300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE) RIVERSTONE RESOURCES SDN. BHD. 510(k) NO: K100611(TRADITIONAL) ATTN: CHONG CHU MEE PHONE NO : 603 602 83033 KAWASAN PERINDUSTRIAN BUKIT 48300 SE DECISION MADE: 16-JUL-10 SELANGOR MY 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDIWORKS SLIT LAMP SHANGHAI MEDIWORKS PRECISION INST510(k) NO: K100439(TRADITIONAL) ATTN: LISA ZHANG PHONE NO : 909 621 2628 1485 ANDREW DR SUITE G SE DECISION MADE: 16-JUL-10 CLAREMONT CA 91711 510(k) STATEMENT DEVICE: PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE) ULTRADENT PRODUCTS, INC. 510(k) NO: K100752(TRADITIONAL) ATTN: DIANE ROGERS PHONE NO : 801 553 4491 505 WEST 10200 SOUTH SE DECISION MADE: 16-JUL-10 SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JULIET OL SPINEART 510(k) NO: K101720(SPECIAL) ATTN: FRANCK PENNESI PHONE NO : 412 279 94025 COINTRIN 20 ROUTE DE PRE-BOIS CP18SE DECISION MADE: 16-JUL-10 GENEVA SZ 1215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WATER BOTTLE CAP SYSTEM UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K101146(TRADITIONAL) ATTN: CARROLL L MARTIN PHONE NO : 440 639 4494 5976 HEISELY RD. SE DECISION MADE: 16-JUL-10 MENTOR OH 44060 510(k) STATEMENT DEVICE: LEV-OR DILATION CATHETER OTW BAYLIS MEDICAL CO., INC. 510(k) NO: K101117(TRADITIONAL) ATTN: MEGHAL KHAKHAR PHONE NO : 905 602 4875 2645 MATHESON BLVD. E SE DECISION MADE: 16-JUL-10 MISSISSAUGA, ONTARIO CA L4W 5S4510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED RESTEP COMPRESSION SLEEVES ASCENT HEATLHCARE SOLUTIONS 510(k) NO: K101087(TRADITIONAL) ATTN: AMANDA BOBCOCK PHONE NO : 480 763 5300 10232 SOUTH 51ST STREET SE DECISION MADE: 16-JUL-10 PHEONIX AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG STAR PLASTIC CO., LTD510(k) NO: K101343(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 86 10 82387441 ROOM 1606 BLDG.1.JIANXIANG YUAN NOSE DECISION MADE: 16-JUL-10 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ERBE ESU MODEL VIO 100 C WITH ACCESSORIES ERBE USA, INC. 510(k) NO: K101108(SPECIAL) ATTN: JOHN TARTAL PHONE NO : 770 955 4400 2225 NORTHWEST PKWY. SE DECISION MADE: 16-JUL-10 MARIETTA GA 30067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) SHIJIAZHUANG SAIL PLASTIC CO., LTD510(k) NO: K101840(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 86 10 82387441 JIANXIANG YUAN #209 BEI SI HUA BLDSE DECISION MADE: 16-JUL-10 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) SHIJIAZHUANG SAIL PLASTIC CO., LTD510(k) NO: K101841(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 86 10 82387441 JIANXIANG YUAN #209 BEI SI HUA BLDSE DECISION MADE: 16-JUL-10 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. 510(k) NO: K101829(TRADITIONAL) ATTN: KYUNG-AM SHIM PHONE NO : 822 219 41381 1003 DAECHI-DONG GANGNAM-GU SE DECISION MADE: 16-JUL-10 SEOUL KS 135-280 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 IND DIAGNOSTIC INC. 510(k) NO: K100031(TRADITIONAL) ATTN: JASON PENG PHONE NO : 604 522 1619 1629 FOSTERS WAY SE DECISION MADE: 19-JUL-10 DELTA, BC CA V3M 6S7 510(k) STATEMENT DEVICE: FIXPINE II SYSTEM DIO MEDICAL CO., LTD. 510(k) NO: K100765(TRADITIONAL) ATTN: JOYCE BANG PHONE NO : 562 404 8466 13340 E. FIRESTONE BLVD. SUITE J SE DECISION MADE: 19-JUL-10 SANTA FE SPRINGS CA 90670 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COHEN CROSSOVER CATHETER VASCULAR SOLUTIONS, INC. 510(k) NO: K101625(TRADITIONAL) ATTN: JENNIFER RUETHER PHONE NO : 763 656 4300 6464 SYCAMORE COURT SE DECISION MADE: 19-JUL-10 MINNEAPOLIS MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIRECT PERORAL CHOLANGIOSCOPY BALLOON WILSON-COOK MEDICAL, INC. 510(k) NO: K101095(TRADITIONAL) ATTN: SCOTTIE FARIOLE PHONE NO : 336 744 0157 4900 BETHANIA STATION ROAD SE DECISION MADE: 19-JUL-10 WINSTON SALEM NC 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EKO 7 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. 510(k) NO: K101455(TRADITIONAL) ATTN: KYUNG-AM SHIM PHONE NO : 822 219 41381 1003 DAECHI-DONG GANGNAM-GU SE DECISION MADE: 19-JUL-10 SEOUL KS 135-280 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SOPIX 2 SOPRO 510(k) NO: K092329(TRADITIONAL) ATTN: RICK ROSATI PHONE NO : 800 289 6367 124 GAITHER DRIVE SUITE 140 SE DECISION MADE: 20-JUL-10 MT. LAUREL NJ 08054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODS HUOT INSTRUMENTS, LLC 510(k) NO: K100702(TRADITIONAL) ATTN: ANNE WARD PHONE NO : 262 373 1700 N50 W13740 OVERVIEW DR. SUITE A SE DECISION MADE: 20-JUL-10 MENOMONEE FALLS WI 53051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM AESCULAP IMPLANT SYSTEMS, INC. 510(k) NO: K100802(TRADITIONAL) ATTN: LISA M BOYLE PHONE NO : 610 984 9274 3773 CORPORATE PWKY. SE DECISION MADE: 20-JUL-10 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GALLERY LAMINOPLASTY FIXATION SYSTEM BIOMET SPINE (AKA EBI, LLC) 510(k) NO: K100805(TRADITIONAL) ATTN: SHIKHA GOLA PHONE NO : 973 299 9300 100 INTERPACE PARKWAY SE DECISION MADE: 20-JUL-10 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATION SKELETAL KINETICS, LLC 510(k) NO: K100986(TRADITIONAL) ATTN: CHRISTINE KUO PHONE NO : 408 350 5842 10201 BUBB RD. SE DECISION MADE: 20-JUL-10 CUPERTINO CA 95014 4167 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SARGON NON-EXPANDABLE DENTAL IMPLANT SARGON ENT., INC. 510(k) NO: K082573(TRADITIONAL) ATTN: DANIEL J MANELLI PHONE NO : 202 885 5548 5335 WISCONSIN AVE. NW SUITE 440 SE DECISION MADE: 21-JUL-10 WASHINGTON DC 20015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-1000 VATECH CO., LTD. 510(k) NO: K092830(TRADITIONAL) ATTN: VINCENT LEE PHONE NO : 281 598 8110 256 NORTH SAM HOUSTON PKWY E. SUITSE DECISION MADE: 21-JUL-10 HOUSTON TX 77060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUPRA SCAN DELIVERY SYSTEM QUANTEL MEDICAL 510(k) NO: K100678(TRADITIONAL) ATTN: PATRICK QUERO PHONE NO : 334 737 45745 21 RUE NEWTON; ZI LE BREZET SE DECISION MADE: 21-JUL-10 CLERMONT FERRAND FR 63039 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235 ION BEAM APPLICATIONS S.A. 510(k) NO: K100766(TRADITIONAL) ATTN: JOHN B REISS PHONE NO : 215 972 7124 1500 MARKET STREET CENTRE SQUARE WSE DECISION MADE: 21-JUL-10 PHILADELPHIA PA 19102 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISCOPE, MODEL 100P,100S HD MEDICAL SERVICES (INDIA) PVT.LT510(k) NO: K100531(TRADITIONAL) ATTN: BILL MURPHY PHONE NO : 858 880 1079 11143 TWINLEAF WAY SE DECISION MADE: 21-JUL-10 SAN DIEGO CA 92131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER- KIMBERLY-CLARK 510(k) NO: K101596(TRADITIONAL) ATTN: LESTER F PADILLA PHONE NO : 678 352 6766 1400 HOLCOMB BRIDGE ROAD SE DECISION MADE: 21-JUL-10 ROSWELL GA 30097 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ECT DIGITAL THERMOMETER CHANGSHAN ESTAR ELECTRONICS CO., L510(k) NO: K101043(TRADITIONAL) ATTN: JACOB CHANG PHONE NO : 886 4 22465396 # 462, SEC 2, CHONGDE ROAD BEITUN SE DECISION MADE: 21-JUL-10 TAICHUNG TW 406 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM ALPHATEC SPINE, INC. 510(k) NO: K101255(TRADITIONAL) ATTN: KARLA SCHAFFNER PHONE NO : 760 494 6739 5818 EL CAMINO REAL SE DECISION MADE: 21-JUL-10 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCOUTPRO HEMOSTATIC VALVE BIOTRONIK, INC. 510(k) NO: K101282(SPECIAL) ATTN: JON BRUMBAUGH PHONE NO : 888 345 0374 6024 JEAN ROAD SE DECISION MADE: 21-JUL-10 LAKE OSWEGO OR 97035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JOINSOON ELECTRONICS MFG CO. LTD HIGH SPEED DIGITAL THERMOMETER, MODEL TC-001 JOINSOON ELECTRONICS MFG CO LTD 510(k) NO: K101232(SPECIAL) ATTN: JIGAR SHAH PHONE NO : 516 482 9001 55 NORTHERN BLVD SUITE 200 SE DECISION MADE: 21-JUL-10 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GIRAFFE INCUBATOR OHMEDA MEDICAL 510(k) NO: K101778(SPECIAL) ATTN: AGATA SMIEJA PHONE NO : 410 888 5200 8880 GORMAN RD. SE DECISION MADE: 21-JUL-10 LAUREL MD 20723 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WVSM (WIRELESS VITAL SIGNS MONITOR), MODEL 5.0 ATHENA GTX 510(k) NO: K101674(TRADITIONAL) ATTN: SEAN MAHONEY PHONE NO : 515 288 3360 3620 SW61ST STREET SUITE 395 SE DECISION MADE: 21-JUL-10 DES MOINES IA 50321 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GIRAFFE OMNIBED OHMEDA MEDICAL 510(k) NO: K101788(SPECIAL) ATTN: AGATA SMIEJA PHONE NO : 410 888 5200 8880 GORMAN RD. SE DECISION MADE: 21-JUL-10 LAUREL MD 20723 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLIDESHEATH TERUMO MEDICAL CORP. 510(k) NO: K102008(TRADITIONAL) ATTN: DANIEL R PLONSKI PHONE NO : 410 392 7395 950 ELKTON BLVD. SE DECISION MADE: 21-JUL-10 ELKTON MD 21921 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GIRAFFE AND PANDA WARMERS OHMEDA MEDICAL, A DIVISION OF DATE510(k) NO: K101804(SPECIAL) ATTN: AGATA SMIEJA PHONE NO : 410 888 5200 8880 GORMAN RD. SE DECISION MADE: 21-JUL-10 LAUREL MD 20723 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENUS BASIC SPINAL FIXATION SYSTEM L & K BIOMED CO., LTD 510(k) NO: K100706(TRADITIONAL) ATTN: HEE KYEONG JOO PHONE NO : 822 262 41471 ROOM 1104, ACE HIGH-END TOWER3 371SE DECISION MADE: 22-JUL-10 HEE KYEONG JOO KS 153803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500 B. BRAUN MEDICAL, INC. 510(k) NO: K100640(TRADITIONAL) ATTN: MATTHEW HOMA PHONE NO : 610 596 2558 901 MARCON BLVD. SE DECISION MADE: 22-JUL-10 ALLENTOWN PA 18109 9341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CPR MASK FIRSTAR HEALTHCARE CO., LTD. 510(k) NO: K083418(TRADITIONAL) ATTN: YOVETTE MUMFORD PHONE NO : 617 312 4400 120 JOHNSON RD. SE DECISION MADE: 22-JUL-10 WINCHESTER MASS MA 01890 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: YRNSORTIP OXIMANOMETER CNOGA MEDICAL LTD 510(k) NO: K093981(TRADITIONAL) ATTN: TALI HAZAN PHONE NO : 972 505 292304 SE DECISION MADE: 22-JUL-10 RAMOT NAFTALI IS 13830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PANPAC VAGINAL PESSARY PANPAC MEDICAL CORPORATION 510(k) NO: K092981(TRADITIONAL) ATTN: YEN-MING PAN PHONE NO : 886 286 472242 NO. 202, 6F-1.2, SEC.3 TATONG ROADSE DECISION MADE: 22-JUL-10 SHI-CHIH CITY, TAIPEI HSIEN TW 510(k) STATEMENT DEVICE: IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081 SHENZHEN DONGDIXIN TECHNOLOGY CO, 510(k) NO: K100488(TRADITIONAL) ATTN: ZHIGANG ZHAO PHONE NO : 867 552 7652471 ESTAE XILIXIAOBAIMANG SE DECISION MADE: 22-JUL-10 NANSHAN DISTRICT, SHENZHEN CH 5510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: QUANTA DIODE LASER SYSTEM QUANTA SYSTEM, S.P.A. 510(k) NO: K100558(TRADITIONAL) ATTN: ISABELLA CARRER PHONE NO : 390 331 376797 VIA IV NOVEMBRE,116 SE DECISION MADE: 22-JUL-10 SOLBIATE OLONA(VA) IT 21058 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: IMPIX LUMBAR INTERBODY DEVICE MEDICREA TECHNOLOGIES 510(k) NO: K100544(SPECIAL) ATTN: JD WEBB PHONE NO : 512 388 0199 1001 OAKWOOD BLVD. SE DECISION MADE: 22-JUL-10 ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUDIT MICROCV PROCALCITONIN LINEARITY AALTO SCIENTIFIC LTD. 510(k) NO: K101434(TRADITIONAL) ATTN: DESSI LYAKOV PHONE NO : 760 431 7922 1959 KELLOGG AVE. SE DECISION MADE: 22-JUL-10 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALEUTIAN IBF SYSTEM K2M, INC. 510(k) NO: K101302(SPECIAL) ATTN: NANCY GIEZEN PHONE NO : 703 777 3155 751 MILLER DR.,SE SE DECISION MADE: 22-JUL-10 LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLARIS REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFS SOLARIS MEDICAL TECHNOLOGY, INC. 510(k) NO: K101972(TRADITIONAL) ATTN: RACHEL CHENG PHONE NO : 650 588 3980 400 OYSTER POINT BLVD. SUITE 534 SE DECISION MADE: 22-JUL-10 SOUTH SAN FRANCISCO CA 94080 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES TEAM INNOVATIONS, INC 510(k) NO: K101576(TRADITIONAL) ATTN: MARK TIEGS PHONE NO : 262 617 6980 2521 SOUTH 98 STREET SE DECISION MADE: 22-JUL-10 WEST ALLIS WI 53227 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V INSTRUMENTATION INDUSTRIES, INC. 510(k) NO: K101857(SPECIAL) ATTN: DORIS F WALTER PHONE NO : 412 854 1133 2990 INDUSTRIAL BLVD. SE DECISION MADE: 22-JUL-10 BETHEL PARK PA 15102 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINI-TONG MINI LAP TECHNOLOGIES INC. 510(k) NO: K101101(TRADITIONAL) ATTN: JOSEPH AZARY PHONE NO : 203 922 0105 80 SHELTON TECHNOLOGY CENTER SE DECISION MADE: 23-JUL-10 SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467 DEPUY ORTHOPAEDICS, INC. 510(k) NO: K101240(TRADITIONAL) ATTN: SUZANA OTANO PHONE NO : 305 269 6386 700 ORTHOPAEDIC DR. SE DECISION MADE: 23-JUL-10 WARSAW IN 46581 0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEFCON TSA/TSH DENTAL IMPLANT SYSTEM IMPLADENT, S.L. 510(k) NO: K092261(ABBREVIATED) ATTN: JOSE-RAMON GUTIERREZ PHONE NO : 349 022 01413 POL.LND MAS D'EN CISA C/ GATO PERESE DECISION MADE: 23-JUL-10 SENTMENAT, BARCELONA SP 08181 510(k) STATEMENT DEVICE: THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000 THERMEDX, LLC 510(k) NO: K091939(TRADITIONAL) ATTN: JEFF B WILLIAMS PHONE NO : 440 542 0883 31200 SOLON ROAD UNIT 1 SE DECISION MADE: 23-JUL-10 SOLON OH 44139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DETAX IMPLANTLINK SEMI DETAX GMBH & CO. KG 510(k) NO: K100247(TRADITIONAL) ATTN: DAGMAR MAESER PHONE NO : 312 042 89591 AMSTEL 320-I SE DECISION MADE: 23-JUL-10 AMSTERDAM NL D-76275 510(k) STATEMENT DEVICE: S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM AESCULAP IMPLANT SYSTEM, INC. 510(k) NO: K100147(SPECIAL) ATTN: LISA BOYLE PHONE NO : 610 797 9300 3773 CORPORATE PWKY. SE DECISION MADE: 23-JUL-10 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USB PULSE BIOMEDICAL, INC. 510(k) NO: K100813(SPECIAL) ATTN: SALEEM HASAN PHONE NO : 610 666 5510 1305 CATFISH LANE SE DECISION MADE: 23-JUL-10 NORRISTOWN PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U WALLAC OY 510(k) NO: K100682(TRADITIONAL) ATTN: KAY TAYLOR PHONE NO : 317 418 1735 8275 CARLOWAY ROAD SE DECISION MADE: 23-JUL-10 INDIANAPOLIS IN 46236 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01 MEDISISS 510(k) NO: K100543(TRADITIONAL) ATTN: BRANDI JAMES PHONE NO : 541 923 3310 2747 SW 6TH STREET SE DECISION MADE: 23-JUL-10 REDMOND OR 97756 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1 AIRSTRIP TECHNOLOGIES, LP 510(k) NO: K100133(TRADITIONAL) ATTN: WILLIAM CAMERON POWELL PHONE NO : 210 805 0444 3303 OAKWELL CT., SUITE 200 SE DECISION MADE: 23-JUL-10 SAN ANTONIO TX 78218 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY (TGS UKA) MODULAR TIBIA SYSTEM ALEXANDRIA RESEARCH TECHNOLOGIES, 510(k) NO: K101206(TRADITIONAL) ATTN: MICHAEL LARSON PHONE NO : 952 949 2235 13755 FIRST AVENUE NORTH SUITE 100SE DECISION MADE: 23-JUL-10 PLYMOUTH MN 55441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM BOSTON SCIENTIFIC CORP. 510(k) NO: K101314(TRADITIONAL) ATTN: ELENA NIEVES PHONE NO : 508 683 4347 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 23-JUL-10 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES BAXANO, INC. 510(k) NO: K100958(SPECIAL) ATTN: EDWARD J SINCLAIR PHONE NO : 408 514 2200 655 RIVER OAKS PKWY SE DECISION MADE: 23-JUL-10 SAN JOSE CA 95134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRO-TOE VO HAMMERTOW IMPLANT SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K101165(TRADITIONAL) ATTN: KELSEY LEE PHONE NO : 901 290 5909 5677 AIRLINE RD. SE DECISION MADE: 23-JUL-10 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED COMPRESSION SLEEVES ASCENT HEALTHCARE SOLUTIONS 510(k) NO: K100909(TRADITIONAL) ATTN: RAMONA KULIK PHONE NO : 480 763 2952 10232 SOUTH 51ST ST. SE DECISION MADE: 23-JUL-10 PHOENIX AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GUARDIAN CONNECTION MAULIN MEDICAL LLC 510(k) NO: K101214(TRADITIONAL) ATTN: SARA OWENS PHONE NO : 719 647 2938 486 E. GENTRY DRIVE SE DECISION MADE: 23-JUL-10 PUEBLO WEST CO 81007 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCOUTPRO ACS BIOTRONIK, INC. 510(k) NO: K101776(SPECIAL) ATTN: JON BRUMBAUGH PHONE NO : 888 345 0374 6024 JEAN ROAD SE DECISION MADE: 23-JUL-10 LAKE OSWEGO OR 97035 510(k) STATEMENT DEVICE: PIONEER PLUS CATHETER, MODEL PLUS 120 MEDTRONIC VASCULAR 510(k) NO: K101777(SPECIAL) ATTN: LUCINDA L FOX PHONE NO : 707 591 7028 3576 UNOCAL PLACE SE DECISION MADE: 23-JUL-10 SANTA ROSA CA 95403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVANIX DOUBLE PIGTAIL BILIARY STENT BOSTON SCIENTIFIC CORP. 510(k) NO: K101786(SPECIAL) ATTN: ELENA NIEVES PHONE NO : 508 683 4347 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 23-JUL-10 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROFAST+ ASSAY GEN-PROBE PRODESSE, INC 510(k) NO: K101855(TRADITIONAL) ATTN: KAREN HARRINGTON PHONE NO : 262 446 0700 W229 N1870 WESTWOOD DR SE DECISION MADE: 23-JUL-10 WAUKESHA WI 53186 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH CRYOLIFE, INC. 510(k) NO: K101866(SPECIAL) ATTN: JOHN D FERROS PHONE NO : 770 419 3355 1655 ROBERTS BLVD., N.W. SE DECISION MADE: 23-JUL-10 KENNESAW GA 30144 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5 INFIMED, INC. 510(k) NO: K101833(SPECIAL) ATTN: JIGAR SHAH PHONE NO : 516 482 9001 55 NORTHERN BLVD. SUITE 200 SE DECISION MADE: 23-JUL-10 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MED-SEG, MODEL BTMS 1000 BARTRON MEDICAL IMAGING, INC. 510(k) NO: K092328(ABBREVIATED) ATTN: ZVI LADIN PHONE NO : 781 407 0900 990 WASHINGTON STREET SE DECISION MADE: 26-JUL-10 DEDHAM MA 02026 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE PANPAC SUCTION CURETTE PANPAC MEDICAL CORPORATION 510(k) NO: K092982(TRADITIONAL) ATTN: YEN-MING PAN PHONE NO : 886 286 472242 NO. 202, 6F-1.2, SEC.3 TATONG ROADSE DECISION MADE: 26-JUL-10 SHI-CHIH CITY, TAIPEI HSIEN TW 510(k) STATEMENT DEVICE: PHILIPS OBTRACEVUE MODEL SW REV. G.00 PHILIPS MEDIZIN SYSTEME BOEBLINGEN510(k) NO: K100420(ABBREVIATED) ATTN: MICHAEL ASMALSKY PHONE NO : 497 031 4631277 HEWLETT-PACKARD STR. 2 SE DECISION MADE: 26-JUL-10 BOEBLINGEN GM 71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNAPSE 3D BASIC TOOLS FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K101662(TRADITIONAL) ATTN: DEBBIE PEACOCK PHONE NO : 203 602 3774 419 WEST AVE. SE DECISION MADE: 26-JUL-10 STAMFORD CT 06902 6300 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NAVIAID ICVI DEVICE SMART MEDICAL SYSTEMS, LTD. 510(k) NO: K101191(TRADITIONAL) ATTN: ADVA YOSELZON PHONE NO : 972 9 7444478 10 HAYETSIRA STREET SE DECISION MADE: 27-JUL-10 RAANANA IS 43663 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AESCULAP STERILCONTAINER S AESCULAP, INC. 510(k) NO: K093493(TRADITIONAL) ATTN: KATHY RACOSKY PHONE NO : 610 984 9291 3773 CORPORATE PARKWAY SE DECISION MADE: 27-JUL-10 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAM COOLER MAM INTERNATIONAL AG 510(k) NO: K093266(TRADITIONAL) ATTN: MICHAEL TEDESCO PHONE NO : 914 269 2500 CORPORATE PARK DRIVE 106 SE DECISION MADE: 27-JUL-10 WHITE PLAINS NY 10604 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE 3M UNITEK 510(k) NO: K100536(TRADITIONAL) ATTN: NIEDRE M HECKMAN PHONE NO : 626 574 4412 2724 SOUTH PECK RD. SE DECISION MADE: 27-JUL-10 MONROVIA CA 91016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES HEBEI EXCELLENT PLASTIC CO., LTD. 510(k) NO: K101663(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 861 082 387441 JIANXIANG YUAN NO.209 BEI SI HUAN SE DECISION MADE: 27-JUL-10 HAIDIAN DISTRICT, BEIJING CH 10510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES HEBEI EXCELLENT PLASTIC CO., LTD. 510(k) NO: K101664(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 861 082 387441 JIANXIANG YUAN NO.209 BEI SI HUAN SE DECISION MADE: 27-JUL-10 HAIDIAN DISTRICT, BEIJING CH 10510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RDT3 HANDPIECE HEAD MODEL RDT3 REDENT NOVA LTD 510(k) NO: K101172(TRADITIONAL) ATTN: JONATHAN S KAHAN PHONE NO : 202 637 5794 COLUMBIA SQUARE 555 13TH STREET, NSE DECISION MADE: 27-JUL-10 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO VIDACARE CORPORATION 510(k) NO: K101026(TRADITIONAL) ATTN: GRACE HOLLAND PHONE NO : 949 262 0411 3722 AVE. SAUSALITO SE DECISION MADE: 27-JUL-10 IRVIN CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROWESS PANTHER PROARC, MODEL VERSION 5.0 PROWESS, INC. 510(k) NO: K101076(TRADITIONAL) ATTN: RACHEL SCARANO PHONE NO : 925 356 0360 1844 CLAYTON ROAD SE DECISION MADE: 27-JUL-10 CONCORD CA 94520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIREBIRD SPINAL FIXATION SYSTEM BLACKSTONE MEDICAL, INC. 510(k) NO: K093926(TRADITIONAL) ATTN: RUSSELL JOHNSON PHONE NO : 972 529 3177 1211 HAMBURG TURNPIKE SUITE 300 SE DECISION MADE: 28-JUL-10 WAYNE NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVIA 2120/2120I BODY FLUIDS SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K090346(TRADITIONAL) ATTN: ERNEST JOSEPH PHONE NO : 914 524 2431 511 BENEDICT AVENUE SE DECISION MADE: 28-JUL-10 TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMPHETAMINES II ASSAY ROCHE DIAGNOSTICS CORP. 510(k) NO: K093664(TRADITIONAL) ATTN: MICHELLE L NEFF PHONE NO : 317 521 2000 9115 HAGUE RD. SE DECISION MADE: 28-JUL-10 INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARIOUS DENTAL IMPLANTS GRUNDY ADVANCED BIOMEDICAL SYSTEMS510(k) NO: K100411(TRADITIONAL) ATTN: WILLIAM SIMMONS PHONE NO : 740 465 5204 832 MARSEILLES- GALION RDW SE DECISION MADE: 28-JUL-10 MARION OH 43302 510(k) STATEMENT DEVICE: ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM SPINEART 510(k) NO: K101678(SPECIAL) ATTN: FRANCK PENNESI PHONE NO : 412 279 94025 COINTRIN 20 ROUTE DE PRE-BOIS CP18SE DECISION MADE: 28-JUL-10 GENEVA SZ 1215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWERWIRE RADIOFREQUENCY GUIDEWIRE BAYLIS MEDICAL CO., INC. 510(k) NO: K101615(SPECIAL) ATTN: MEGHAL KHAKHAR PHONE NO : 905 602 4875 2645 MATHESON BLVD. E SE DECISION MADE: 28-JUL-10 MISSISSAUGA, ONTARIO CA L4W 5S4510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404 CHEMENCE MEDICAL PRODUCTS INC. 510(k) NO: K101276(TRADITIONAL) ATTN: PATRICIA LEHMAN PHONE NO : 678 879 5446 185 BLUEGRASS VALLEY PARKWAY SUITESE DECISION MADE: 28-JUL-10 ALPHARETTA GA 30005 2222 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MROPEN PARAMED SRL 510(k) NO: K101295(TRADITIONAL) ATTN: RICHARD R GLASHEEN PHONE NO : 978 975 7530 39 HIGH STREET SE DECISION MADE: 28-JUL-10 NORTH ANDOVER MA 01845 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JOINSOON ELECTRONICS MFG CO., LTD INFRARED EAR THERMOMETER, MODEL TT-001 JOINSOON ELECTRONICS MFG CO LTD 510(k) NO: K101322(SPECIAL) ATTN: JIGAR SHAH PHONE NO : 516 482 9001 55 NORTHERN BLVD SUITE 200 SE DECISION MADE: 28-JUL-10 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10 CEPHEID 510(k) NO: K101879(SPECIAL) ATTN: RUSSEL K ENNS, PH.D. PHONE NO : 408 400 8230 904 CARIBBEAN DRIVE SE DECISION MADE: 28-JUL-10 SUNNYVALE CA 94089 1189 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601 SHANGHAI CHENGUANG MEDICAL TECHNOL510(k) NO: K101949(TRADITIONAL) ATTN: JIE HUANG PHONE NO : 862 152 961075837 BLDG 8, LANE 1199, JIDI ROAD SE DECISION MADE: 28-JUL-10 SHANGHAI CH 201107 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: HYDROFIX VASO SHIELD, MODEL HVS-001-0610 MIMEDX GROUP, INC 510(k) NO: K101826(SPECIAL) ATTN: SALLY THORSEN PHONE NO : 678 384 6720 811 LIVINGSTON COURT SE SUITE B SE DECISION MADE: 28-JUL-10 MARIETTA GA 30067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TALYMED MARINE POLYMER TECHNOLOGIES 510(k) NO: K102002(TRADITIONAL) ATTN: SERGIO FINKIELSZTEIN PHONE NO : 781 270 3200 107 WATER STREET SE DECISION MADE: 28-JUL-10 DANVERS MA 01983 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOGENNIX RPC BIOGENNIX, LLC 510(k) NO: K093342(TRADITIONAL) ATTN: EDWIN C SHORS PHONE NO : 949 253 0994 19200 VON KARMAN AVE SUITE 400 SE DECISION MADE: 29-JUL-10 IRVINE CA 92612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IN VISION-PLUS NANO WITH NEUTRAL ADVANTAGE TECHNOLOGY RYMED TECHNOLOGIES, INC. 510(k) NO: K093489(TRADITIONAL) ATTN: JOSEPH AZARY PHONE NO : 203 922 0105 80 SHELTON TECHNOLOGY CENTER SE DECISION MADE: 29-JUL-10 SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORA CONTROL SOLUTION, TAIDOC CONTROL SOLUTION TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K093724(TRADITIONAL) ATTN: DEBRA LIANG PHONE NO : 886 266 258188 6F, NO. 127, WUGONG 2ND RD WUGU TOSE DECISION MADE: 29-JUL-10 TAIPEI COUNTY TW 248 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOSKELETON TC TITAN SPINE, LLC 510(k) NO: K100889(TRADITIONAL) ATTN: JOHN J SMITH PHONE NO : 202 637 3638 555 13TH ST, NW SE DECISION MADE: 29-JUL-10 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZOLL PROPAQ MD ZOLL MEDICAL CORPORATION, WORLD WI510(k) NO: K100654(TRADITIONAL) ATTN: PAUL DIAS PHONE NO : 978 421 9413 269 MILL ROAD SE DECISION MADE: 29-JUL-10 CHELMSFORD MA 01824 4105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 C.R. BARD, INC. 510(k) NO: K101261(TRADITIONAL) ATTN: MARK NELSON PHONE NO : 801 522 5000 605 N 5600 W SE DECISION MADE: 29-JUL-10 SALT LAKE CITY UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O PHILIPS MEDICAL SYSTEMS 510(k) NO: K101521(SPECIAL) ATTN: LOIS GIEGERICH PHONE NO : 978 659 7809 3000 MINUTEMAN ROAD, MS 0480 SE DECISION MADE: 29-JUL-10 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H GAMBRO RENAL PRODUCTS, INC. 510(k) NO: K093608(TRADITIONAL) ATTN: KAE MILLER PHONE NO : 303 542 5045 14143 DENVER WEST PARKWAY SUITE 40SE DECISION MADE: 29-JUL-10 LAKEWOOD CO 80401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHREX BIOWIRE ARTHREX, INC. 510(k) NO: K091018(TRADITIONAL) ATTN: SALLY FOUST PHONE NO : 239 643 5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 30-JUL-10 NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VEGA KNEE SYSTEM AESCULAP IMPLANT SYSTEM, INC. 510(k) NO: K101281(TRADITIONAL) ATTN: KATHY A RACOSKY PHONE NO : 610 984 9291 3773 CORPORATE PARKWAY SE DECISION MADE: 30-JUL-10 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIGILANT EEG MONITOR MODEL VIGILANT 2.0 INFINITE BIOMEDICAL TECHNOLOGIES, 510(k) NO: K101386(SPECIAL) ATTN: MANAN HATHI PHONE NO : 410 889 8011 3600 CLIPPER MILL ROAD SUITE 410 SE DECISION MADE: 30-JUL-10 BALTIMORE MD 21211 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTIBOND XTR KERR CORPORATION 510(k) NO: K101423(TRADITIONAL) ATTN: WENDY GARMAN PHONE NO : 714 516 7602 1717 WEST COLLINS AVENUE SE DECISION MADE: 30-JUL-10 ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMIGO CLASSIC FD AMIGO MOBILITY INTL., INC. 510(k) NO: K101507(ABBREVIATED) ATTN: MIKE LABRAKE PHONE NO : 989 777 0910 6693 DIXIE HWY. SE DECISION MADE: 30-JUL-10 BRIDGEPORT MI 48722 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMS PIEZON MASTER 700 EMS ELECTRO MEDICAL SYSTEMS SA 510(k) NO: K093000(TRADITIONAL) ATTN: CYNTHIA J.M NOLTE PHONE NO : 919 859 4207 49 PLAIN ST. SE DECISION MADE: 30-JUL-10 NORTH ATTLEBORO MA 02760 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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