FDA releases July 510(k) clearances

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The Food & Drug Administration released the pre-market approvals it granted during July:

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

RSS From Medical Design & Outsourcing

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    Molex, LLC operates a fully ISO 146441-1:1999 Class 8-certified clean room, satisfying strict particulate contamination levels specified by ISO-compliant requirements. Located in Thailand, the facility has less than 100,000 particulates (≥0.5µm) per cubic foot of air and manufactures a variety of ISO 13485-compliant medical cables and surgical cables used in operating theatres, hospitals, laboratories and […]
  • Swept-Source OCT: Patent license agreement between Massachusetts General Hospital and Heidelberg Engineering
    Heidelberg Engineering has entered into a patent license agreement with Massachusetts General Hospital (MGH) in Boston. The agreement grants global and exclusive rights to 77 basic patents and patent applications which relate to swept-source OCT technology and its application in ophthalmology. Spectral domain OCT has become indispensable to eye care professionals worldwide to diagnose and […]
  • MIT’s MultiFab presents a stark challenge to incumbent 3D Printer manufacturers’ hardware, software, and business Models
    MIT’s Computational Fabrication Group recently announced the MultiFab, a low-cost 3D printer that can combine up to 10 different resins in one part and also includes a 3D scanning system to identify and fix errors during production. According to Lux Research, these capabilities are rare in commercial 3D printers today due to the manufacturers’ need […]
  • AVX releases Accu-P MP medical grade film chip capacitors for medical devices
    AVX Corporation, a leading manufacturer of passive components and interconnect solutions, has released a new series of thin film chip capacitors specifically designed to meet the demanding performance specifications for implantable medical devices. Delivering extremely tight capacitive tolerances, exceptionally repeatable performance, and remarkably low ESR and high Q at high frequencies—including VHF, UHF, and RF […]
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    If you’ve burned out your ears with earbuds, headphones or decades of other audio abuse but aren’t ready for your grandmother’s hearing aids, not to worry! The new MDHearingAid FIT gets you back in the game with a tiny, FDA-registered, one-size-fits-most solution that doesn’t block your ear canal like old-fashioned in-the-ear hearing aids. The FIT feels […]
  • CardioGenics enters into manufacturing agreement with Ontario-based Plasticap
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  • MTD Micro Molding releases micro materials menu
    MTD Micro Molding, a long-time leader in micro-injection molding, has released an updated “Materials Menu” of materials that can be successfully micromolded to help guide engineers at medical device companies. Material selection is a crucial step in product manufacturability. The correct material drives tolerance, dimension, strength, usabality, speed-to-market, design, critical features, and cost. Through MTD’s […]
  • MedTech Chat: Elastic technology for drug delivery
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