-
Medical Devices
-
September 2009 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD September 2009 DEVICE: ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 10000 WCM WASTE & COMPLIANCE MANAGEMENT,510(k) NO: K090156(TRADITIONAL)
ATTN: SARA BETH WATSON PHONE NO : 202 429 6460 1330 CONNECTICUT AVE., NW SE DECISION MADE: 01-SEP-09 WASHINGTON DC 20036 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 BINAX, INC. 510(k) NO: K083744(TRADITIONAL)
ATTN: ANNE JEPSON PHONE NO : 207 730 5750 10 SOUTHGATE RD. SE DECISION MADE: 01-SEP-09 SCARBOROUGH ME 04074 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRIMAEVA MEDICAL RENESIS SYSTEM PRIMAEVA MEDICAL, INC. 510(k) NO: K082391(TRADITIONAL)
ATTN: BRIAN GRIGSBY PHONE NO : 925 621 6100 4160 HACIENDA DR., SUITE 100 SE DECISION MADE: 01-SEP-09 PLEASANTON CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERIFY SCBI 275F 3-10 STERIS CORPORATION 510(k) NO: K083665(ABBREVIATED)
ATTN: JOHN ROBERT SCOVILLE, JR. PHONE NO : 440 354 2600 5960 HEISLEY RD. SE DECISION MADE: 01-SEP-09 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267 LUMINEX MOLECULAR DIAGNOSTICS, INC510(k) NO: K083846(TRADITIONAL)
ATTN: GLORIA LEE PHONE NO : 416 593 4323 439 UNIVERSITY AVE. SE DECISION MADE: 01-SEP-09 TORONTO, ONTARIO CA M5G 1Y8 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY FIAB SPA 510(k) NO: K083428(TRADITIONAL)
ATTN: SILVIA CALABRO PHONE NO : 39 055 84979216 VIA COSTOLI, 4 VICCHIO SE DECISION MADE: 01-SEP-09 FIRENZE IT 50039 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VALVED TEARWAY INTRODUCER MEDCOMP 510(k) NO: K090394(TRADITIONAL)
ATTN: JEAN CALLOW PHONE NO : 215 256 4201 1499 DELP DR. SE DECISION MADE: 01-SEP-09 HARLEYSVILLE PA 19438 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILS CLINCHER, SILS DISSECTOR, SILS GRASPER, SILS L-HOOK, SILS SHEARS COVIDIEN LP, FORMERLY REGISTERED A510(k) NO: K091869(SPECIAL)
ATTN: ROBERT ZOTT PHONE NO : 203 492 6013 60 MIDDLETOWN AVENUE SE DECISION MADE: 01-SEP-09 NORTH HAVEN CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH CARDIAC LEAD TECHNOLOGIES, INC. 510(k) NO: K090496(TRADITIONAL)
ATTN: CLAUDIA LEWIS-ENG PHONE NO : 202 344 4359 575 7TH ST. NW SE DECISION MADE: 01-SEP-09 WASHINTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MC-245, MC-246, MC-247, MC-341, MC-343, MC-344 OMRON HEALTHCARE, INC. 510(k) NO: K091676(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DRIVE SE DECISION MADE: 01-SEP-09 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EK/P. AERUGINOSA PNA FISH ADVANDX, INC. 510(k) NO: K092393(TRADITIONAL)
ATTN: PAULA E BULGER PHONE NO : 781 376 0009 10A ROESSLER ROAD SE DECISION MADE: 01-SEP-09 WOBURN MA 01801 510(k) STATEMENT DEVICE: AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 3MM LOCKING INSERTS HOWMEDICA OSTEONICS CORP. 510(k) NO: K092419(SPECIAL)
ATTN: MELISSA A MATARESE PHONE NO : 201 831 5116 325 CORPORATE DRIVE SE DECISION MADE: 01-SEP-09 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIPISYSTEMS AQUAVAGE, MODELS AV2000 AND AV1200 MEDICAL DEVICE RESOURCE CORP. 510(k) NO: K092284(SPECIAL)
ATTN: MELBOURNE KIMSEY PHONE NO : 510 732 9950 23392 CONNECTICUT ST. SE DECISION MADE: 01-SEP-09 HAYWARD CA 94545 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WIENER LAB. URINE STRIP 10 AND 11 WIENER LABORATORIOS S.A.I.C. 510(k) NO: K083724(TRADITIONAL)
ATTN: VIVINA CETOLA PHONE NO : 54 341 4329191 2944 RIOBAMBA SE DECISION MADE: 02-SEP-09 ROSARIO AR 2000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GSO PCT SPINAL SYSTEM GOLD STANDARD ORTHOPAEDICS, LLC 510(k) NO: K091359(TRADITIONAL)
ATTN: DAVID BAUGHMAN PHONE NO : 502 581 8770 1226 ROWAN ST. SE DECISION MADE: 02-SEP-09 LOUISVILLE KY 40203 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMRX IMRIS, INC. 510(k) NO: K091166(TRADITIONAL)
ATTN: THOMAS M TSAKERIS PHONE NO : 301 330 2076 16809 BRIARDALE ROAD SE DECISION MADE: 02-SEP-09 ROCKVILLE MD 20855 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERETE COMPRESSION SCREWS MERETE MEDICAL GMBH 510(k) NO: K091798(TRADITIONAL)
ATTN: JORG MIETZNER PHONE NO : 914 967 1532 49 PURCHASE STREET SE DECISION MADE: 02-SEP-09 RYE NY 10580 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM MEDTRONIC NEUROSURGERY 510(k) NO: K091312(TRADITIONAL)
ATTN: JEFFERY HENDERSON PHONE NO : 805 571 8445 125 CREMONA DR. SE DECISION MADE: 02-SEP-09 GOLETA CA 93117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEUTRASAL BARTOR PHARMACAL CO., INC. 510(k) NO: K091718(TRADITIONAL)
ATTN: EDWARD D KOBUS PHONE NO : 914 715 6232 25 RAVENNA DRIVE SE DECISION MADE: 02-SEP-09 POMONA NY 10970 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K091974(SPECIAL)
ATTN: CHRIS MCKEE PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 02-SEP-09 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHISON DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED ARRAY PROBE, TRANSVAGINAL CHISON MEDICAL IMAGING CO., LTD. 510(k) NO: K091877(TRADITIONAL)
ATTN: BOB LEIKER PHONE NO : 925 556 1302 7263 CRONIN CIRCLE SE DECISION MADE: 02-SEP-09 DUBLIN CA 94568 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTICAL COHERENCE TOMOGRAPHY ED OCT-2000 TOPCON CORP. 510(k) NO: K092470(SPECIAL)
ATTN: TAKAO SUGAWARA PHONE NO : 813 355 82566 75-1 HASUNUMA-CHO ITABASHI-KU SE DECISION MADE: 02-SEP-09 TOKYO JA 174 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000 BRIDGEPOINT MEDICAL 510(k) NO: K091841(SPECIAL) ATTN: JILL MUNSINGER PHONE NO : 763 225 8510 2800 CAMPUS DRIVE #50 SE DECISION MADE: 02-SEP-09 PLYMOUTH MN 55441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER INNOVA VISION INC. 510(k) NO: K083288(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928 773 9488 2904 N. BOLDT DRIVE SE DECISION MADE: 03-SEP-09 FLAGSTAFF AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 COOK UROLOGICAL, INC. 510(k) NO: K082939(TRADITIONAL)
ATTN: CINDY FOOTE PHONE NO : 812 339 2235 750 DANIELS WAY SE DECISION MADE: 03-SEP-09 BLOOMINGTON IN 47404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STAXX XD SYSTEM SPINE WAVE, INC. 510(k) NO: K090315(TRADITIONAL)
ATTN: ROAIDA RIZKALLAH PHONE NO : 203 944 9494 TWO ENTERPRISE DR. SUITE 302 SE DECISION MADE: 03-SEP-09 SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KAPPA LIGHT CHAINS SENTINEL CH. SPA 510(k) NO: K083602(TRADITIONAL)
ATTN: YANGTSE PORTELLES PHONE NO : 39 023 4551456 VIA ROBERT KOCH, 2 SE DECISION MADE: 03-SEP-09 MILANO IT 20152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120 THERATEST LABORATORIES, INC. 510(k) NO: K090760(TRADITIONAL)
ATTN: GABRIELLA LAKOS PHONE NO : 630 627 6069 1111 N. MAIN ST. SE DECISION MADE: 03-SEP-09 LOMBARD IL 60148 510(k) STATEMENT DEVICE: COMFORT TWIN NASAL MASK RESPIRONICS INC., SLEEP & HOME RES510(k) NO: K091066(TRADITIONAL)
ATTN: ZITA A YURKO PHONE NO : 724 387 4120 1001 MURRY RIDGE LN. SE DECISION MADE: 03-SEP-09 MURRYSVILLE PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GSP INSTRUMENT AND GSP NEONATAL HTSH KIT PERKINELMER, INC. 510(k) NO: K090846(TRADITIONAL)
ATTN: KAY A TAYLOR PHONE NO : 317 418 1735 8275 CARLOWAY ROAD SE DECISION MADE: 03-SEP-09 INDIANAPOLIS IN 46236 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSUFLOW DEWHEART LEXION MEDICAL, LLC. 510(k) NO: K091366(TRADITIONAL)
ATTN: BERNARD HORWATH PHONE NO : 651 635 0000 5000 TOWNSHIP PKWY SE DECISION MADE: 03-SEP-09 ST. PAUL MN 55110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENUS DIAMOND FLOW HERAEUS KULZER, LLC 510(k) NO: K091635(ABBREVIATED)
ATTN: CHERYL ZIMMERMAN PHONE NO : 574 299 5444 300 HERAEUS WAY SE DECISION MADE: 03-SEP-09 SOUTH BEND IN 46614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPK SEALANT 3M COMPANY 510(k) NO: K091632(TRADITIONAL)
ATTN: SHARI MYSZKA PHONE NO : 651 736 6955 3M CENTER,BLDG. 275-2W-08 SE DECISION MADE: 03-SEP-09 ST. PAUL MN 55144 1000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC 500, KC600 KIMBERLY-CLARK CORP. 510(k) NO: K091685(TRADITIONAL)
ATTN: LISA PEACOCK PHONE NO : 706 216 3413 172 CONDUCTOR DRIVE SE DECISION MADE: 03-SEP-09 DAWSONVILLE GA 30534 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CYNOSURE SMARTLIPO MULTIWAVELENGTH LASER WITH 1440NM WAVELENGTH CYNOSURE, INC. 510(k) NO: K091537(TRADITIONAL)
ATTN: ANTHONY BURNS PHONE NO : 978 256 4200 5 CARLISLE ROAD SE DECISION MADE: 03-SEP-09 WESTFORD MA 01886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927 ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K091861(SPECIAL)
ATTN: MARLENE A HANNA PHONE NO : 585 453 4041 100 INDIGO CREEK DR. SE DECISION MADE: 03-SEP-09 ROCHESTER NY 14626 5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B, BV243Q-A, B-V243Q-B, B-V443Q-A OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K091495(TRADITIONAL)
ATTN: STACY ABBATIELLO PHONE NO : 484 896 5405 3500 CORPORATE PARKWAY SE DECISION MADE: 03-SEP-09 CENTER VALLEY PA 18034 0610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD)., PVCN100 (PV CONSOLE) PATHWAY MEDICAL TECHNOLOGIES, INC.510(k) NO: K092332(SPECIAL)
ATTN: BRIAN CLEARY PHONE NO : 425 636 4079 10801 120TH AVENUE NE SE DECISION MADE: 03-SEP-09 KIRKLAND WA 98033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPIROPRO VIASYS HEALTHCARE GMBH 510(k) NO: K092324(SPECIAL)
ATTN: THOMAS RUST PHONE NO : 499 314 972383 LEIBNIZSTRASSE 7 SE DECISION MADE: 03-SEP-09 HOECHBERG GM 97204 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASCEND NEUROMETRIX, INC. 510(k) NO: K091155(TRADITIONAL)
ATTN: RAINER MAAS PHONE NO : 781 890 9989 62 FOURTH AVE. SE DECISION MADE: 03-SEP-09 WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ICS CHARTR EP 200 GN OTOMETRICS 510(k) NO: K092373(SPECIAL)
ATTN: DANIEL KAMM PHONE NO : 847 374 8854 333 MILFORD RD SE DECISION MADE: 03-SEP-09 DEERFIELD IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRONG IMPLANT HANDPIECES SAESHIN PRECISION CO., LTD. 510(k) NO: K092412(TRADITIONAL)
ATTN: SEONG NAM KIM PHONE NO : 82 283 85517 1007, BYUCKSAN 2CHA 481-10,GASAN-DSE DECISION MADE: 03-SEP-09 SEOUL KS 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B JIANGSU YUYUE MEDICAL EQUIPMENT & 510(k) NO: K083559(TRADITIONAL)
ATTN: NORMAN F ESTRIN PHONE NO : 301 279 2899 9109 COPENHAVER DR. SE DECISION MADE: 04-SEP-09 POTOMAC MD 20854 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRULY AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODEL DW100,DW200, DW500,DW700,DW703,DW701M.702M TRULY INSTRUMENT CO., LTD. 510(k) NO: K091415(ABBREVIATED)
ATTN: YANG JIAN-HAO PHONE NO : 860 660 3380070 TRULY INDUSTRICAL AREA SE DECISION MADE: 04-SEP-09 SHANWEI SHI, GUANG DONG CH 5166510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT) CONVATEC, A DIVISION OF E.R. SQUIB510(k) NO: K090254(TRADITIONAL)
ATTN: PATRICIA KEARINS PHONE NO : 908 904 2180 200 HEADQUARTERS PARK DR. SE DECISION MADE: 04-SEP-09 SKILLMAN NJ 08558 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS CATHETER WITH EZ STEER BIOSENSE WEBSTER, INC. 510(k) NO: K090898(SPECIAL)
ATTN: NATALIE BENNINGTON PHONE NO : 909 839 7272 3333 DIAMOND CANYON RD. SE DECISION MADE: 04-SEP-09 DIAMOND BAR CA 91765 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATLAS SPINE SPACER ATLAS SPINE LLC 510(k) NO: K091406(TRADITIONAL)
ATTN: JEANNETTE DAILEY PHONE NO : 561 354 4319 1555 JUPITER PARK DR., STE. 4 SE DECISION MADE: 04-SEP-09 JUPITER FL 33458 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERAMENT IBONE VOID FILLER HIGH CONTRAST, MODEL A 0210-12 BONESUPPORT AB 510(k) NO: K090871(TRADITIONAL)
ATTN: ANN-CHRISTINE PROVOOST PHONE NO : 46 46 2865370 SCHEELEVAGEN 19A IDEON SCIENCE PARSE DECISION MADE: 04-SEP-09 LUND SW SE 223-70 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EES SINGLE SITE LAPAROSCOPIC SEAL CAP ASSEMBLY W/ACCESSORIES, MODEL SSL3P, EES FIXED- LENGTH ACCESS RETRACTORS ETHICON ENDO-SUGERY, LLC 510(k) NO: K091211(TRADITIONAL)
ATTN: ASIFA VONHOF PHONE NO : 513 337 3118 4545 CREEK RD. SE DECISION MADE: 04-SEP-09 CINCINNATI OH 45242 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M TRULY INSTRUMENT CO., LTD. 510(k) NO: K091434(ABBREVIATED)
ATTN: YANGJIAN HAO PHONE NO : 860 660 3380070 TRULY INDUSTRICAL AREA SE DECISION MADE: 04-SEP-09 SHANWEI SHI, GUANG DONG CH 5166510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS HARTALEGA SDN BHD 510(k) NO: K091652(TRADITIONAL)
ATTN: NURUL AISYAH KONG BT ABDULLPHONE NO : 603 327 10277 NO. 7, KAWASAN PERUSAHAAN SURIA SE DECISION MADE: 04-SEP-09 BESTARI JAYA MY 45600 510(k) STATEMENT DEVICE: UCP HOME DRUG SCREENING TESTS UCP BIOSCIENCES, INC. 510(k) NO: K091588(TRADITIONAL)
ATTN: NANCY CHEN PHONE NO : 408 392 0064 1445 KOLL CIRCLE, STE. 111 SE DECISION MADE: 04-SEP-09 SAN JOSE CA 95112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARVIEW ADVANCED STREP A , MODEL 737-430 BINAX, INC. 510(k) NO: K091489(TRADITIONAL)
ATTN: ERIN E KENALEY PHONE NO : 207 730 5824 10 SOUTHGATE RD. SE DECISION MADE: 04-SEP-09 SCARBOROUGH ME 04074 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEM HEART ONE/ONE+ GEM-MED S.L. 510(k) NO: K092576(TRADITIONAL)
ATTN: WILSON TSENG PHONE NO : 349 353 09650 CALLE CARTAGENA, 5E, OF. 5-6 SE DECISION MADE: 04-SEP-09 BARCELONA SP 08025 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: INREACH SYSTEM, MODEL AAS00161-02 SUPERDIMENSION, LTD. 510(k) NO: K092365(SPECIAL)
ATTN: JONATHAN KOVACH PHONE NO : 763 210 4015 161 CHESHIRE LANE NORTH, SUITE 100SE DECISION MADE: 04-SEP-09 MINNEAPOLIS MN 55441 5433 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS SPECTRANETICS CORP. 510(k) NO: K092396(SPECIAL)
ATTN: CHERYL HASTINGS PHONE NO : 719 447 2482 96 TALAMINE CT. SE DECISION MADE: 04-SEP-09 COLORADO SPRINGS CO 80907 5159 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES INVIRO MEDICAL DEVICES, INC. 510(k) NO: K092413(SPECIAL)
ATTN: JIM BARLEY PHONE NO : 949 481 5713 1755 NORTH BROWN ROAD SUITE 150 SE DECISION MADE: 04-SEP-09 LAWRENCEVILLE GA 30043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLO-SURPLUS P.A.D. SCION CARDIO-VASCULAR, INC. 510(k) NO: K092552(TRADITIONAL)
ATTN: DENNIS HAMMOND PHONE NO : 305 259 8880 14256 SW 119TH AVE. SE DECISION MADE: 04-SEP-09 MIAMI FL 33186 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 1 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML LUERL LOCK SAFETY SYRINGES INVIRO MEDICAL DEVICES, INC. 510(k) NO: K092430(SPECIAL)
ATTN: JIM BARLEY PHONE NO : 949 481 5713 1755 NORTH BROWN ROAD SUITE 150 SE DECISION MADE: 04-SEP-09 LAWRENCEVILLE GA 30043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM BOSTON SCIENTIFIC CORPORATION 510(k) NO: K092455(SPECIAL)
ATTN: SHANNON PETIT PHONE NO : 763 494 2833 ONE SCIMED PLACE SE DECISION MADE: 04-SEP-09 MAPLE GROVE MN 55311 1566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO SI JOINT FUSION SYSTEM SI-BONE, INC. 510(k) NO: K092375(SPECIAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202 637 5813 555 THIRTEENTH ST., NW SE DECISION MADE: 04-SEP-09 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200 MEDICA CORP. 510(k) NO: K091991(SPECIAL)
ATTN: PHOTIOS MAKRIS PHONE NO : 781 275 4892 5 OAK PARK DRIVE SE DECISION MADE: 04-SEP-09 BEDFORD MA 01730 510(k) STATEMENT DEVICE: FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3 FUJIREBIO DIAGNOSTICS, INC. 510(k) NO: K092645(TRADITIONAL)
ATTN: JOHN GORMLEY PHONE NO : 830 372 1391 940 CROSSROADS BLVD. SE DECISION MADE: 05-SEP-09 SEGUIN TX 78155 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DOCTOR SMILE A-810 AND B-980 LASERS LAMBDA SCIENTIFIC SPA 510(k) NO: K091562(ABBREVIATED)
ATTN: BOSCHI ALESSANDRO PHONE NO : 39 044 4349165 VIA RETRONE 39 SE DECISION MADE: 08-SEP-09 ALTAVILLA VICENTINA, VICENZA IT510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANGLEFIX T LOCKING PLATE, MODELS AF-001 (PLATE), ST-1 (LOCKING SCREW) ANGLEFIX 510(k) NO: K091619(TRADITIONAL)
ATTN: RICHARD JANSEN PHONE NO : 952 431 5999 135 GUILD AVE. SE DECISION MADE: 08-SEP-09 APPLE VALLEY MN 55124 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP CODMAN & SHURTLEFF, INC. 510(k) NO: K091921(SPECIAL)
ATTN: PAUL AMARAL PHONE NO : 508 828 3393 325 PARAMOUNT DR. SE DECISION MADE: 08-SEP-09 RAYNHAM MA 02767 0350 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINAL FORAMINOSCOPE BLAZEJEWSKI MEDI-TECH GMBH 510(k) NO: K082841(TRADITIONAL)
ATTN: ANGELIKA SCHERP PHONE NO : 31 20 6125626 AMSTEL 320-I SE DECISION MADE: 09-SEP-09 AMSTERDAM NL 1017AP 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603 DIASORIN, INC. 510(k) NO: K090104(TRADITIONAL)
ATTN: KELLY R SAUER PHONE NO : 651 439 9710 1951 NORTHWESTERN AVE. SE DECISION MADE: 09-SEP-09 STILLWATER MN 55082 0285 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 ALFA WASSERMANN, INC. 510(k) NO: K091544(TRADITIONAL)
ATTN: HYMAN KATZ PHONE NO : 973 852 0158 4 HENDERSON DR. SE DECISION MADE: 09-SEP-09 WEST CALDWELL NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: CONFORMIS IUNI UNICONDYLAR KNEE REPAIR SYSTEM CONFORMIS, INC. 510(k) NO: K092441(SPECIAL)
ATTN: AMITA SHAH PHONE NO : 781 345 9164 2 FOURTH AVENUE SE DECISION MADE: 09-SEP-09 BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM OBP CORPORATION 510(k) NO: K091937(TRADITIONAL)
ATTN: KEITH ISAACSON PHONE NO : 978 289 8167 360 MERRIMACK STREET BUILDING 9 SE DECISION MADE: 09-SEP-09 LAWRENCE MA 01843 510(k) STATEMENT DEVICE: NSM-S15 SYSTEM NEUSOFT MEDICAL SYSTEMS CO., LTD. 510(k) NO: K092237(TRADITIONAL)
ATTN: TIAN YUEHUI PHONE NO : 86 24 83660646 NO.3-11, WENHUA ROAD HEPING DISTRISE DECISION MADE: 09-SEP-09 SHENYANG, LIAONING CH 110004 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: UNITY BETA PLLA SYSTEM BONUTTI RESEARCH, INC. 510(k) NO: K090175(TRADITIONAL)
ATTN: PATRICK BALSMANN PHONE NO : 217 343 3412 2600 SOUTH RANEY P.O. BOX 1367 SE DECISION MADE: 10-SEP-09 EFFINGHAM IL 62401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEOMED FOOT PLATING SYSTEM OSTEOMED L.P. 510(k) NO: K091614(TRADITIONAL)
ATTN: ALMA RELJA PHONE NO : 972 677 4781 3885 ARAPAHO RD. SE DECISION MADE: 10-SEP-09 ADDISON TX 75001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057 HANSEN MEDICAL, INC. 510(k) NO: K091808(SPECIAL)
ATTN: KATE WHITIN PHONE NO : 650 404 5800 800 E. MIDDLEFIELD ROAD SE DECISION MADE: 10-SEP-09 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BISQUE ZIRCONIA BLANKS, MODEL R610191, R610210, R610211, R610205 REFRACTRON TECHNOLOGIES CORP. 510(k) NO: K091852(TRADITIONAL)
ATTN: JOHN GAGLIARDI PHONE NO : 513 315 9820 7736 WOODSIDE COURT SE DECISION MADE: 10-SEP-09 MAINEVILLE OH 45039 9798 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALCATEL-LUCENT TELEHEATH MANAGER ALCATEL-LUCENT CANADA INC. 510(k) NO: K092635(TRADITIONAL)
ATTN: ALEX GIOSA PHONE NO : 1380 RODICK RD. SE DECISION MADE: 10-SEP-09 MARKHAM, ON CA L3R 4G5 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A CARDIAC SCIENCE CORPORATION 510(k) NO: K091943(SPECIAL)
ATTN: BEVERLY MAGRANE PHONE NO : 425 402 2365 3303 MONTE VILLA PKWY. SE DECISION MADE: 10-SEP-09 BOTHELL WA 98021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMFORT TWIN NASAL MASK RESPIRONICS INC., SLEEP & HOME RES510(k) NO: K091843(TRADITIONAL)
ATTN: ZITA A YURKO PHONE NO : 724 387 4120 1001 MURRY RIDGE LN. SE DECISION MADE: 10-SEP-09 MURRYSVILLE PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VALLEYLAB SUCTION COAGULATOR, MODEL E3305 COVIDIEN LP 510(k) NO: K091223(TRADITIONAL)
ATTN: PHILIP AKE PHONE NO : 303 581 6934 5920 LONGBOW DR. SE DECISION MADE: 11-SEP-09 BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS URIT MEDICAL ELECTRONIC CO., LTD. 510(k) NO: K082811(TRADITIONAL)
ATTN: MARIA GRIFFIN PHONE NO : 516 482 9001 55 NORTHERN BLVD. SUITE 200 SE DECISION MADE: 11-SEP-09 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DENSICHEK PLUS BIOMERIEUX, INC. 510(k) NO: K083536(TRADITIONAL)
ATTN: JOLYN TENLLADO PHONE NO : 314 731 8386 595 ANGLUM RD. SE DECISION MADE: 11-SEP-09 HAZELWOOD MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1 UROVAL 510(k) NO: K083679(TRADITIONAL)
ATTN: SHARON IVERSON PHONE NO : 952 227 3381 5353 WAYZATA BLVD. SUITE 505 SE DECISION MADE: 11-SEP-09 MINNEAPOLIS MN 55416 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VF LIQUIGEL COAPT SYSTEMS, INC. 510(k) NO: K083783(TRADITIONAL)
ATTN: LOUIS-PIERRE MARCOUX PHONE NO : 650 461 7651 1820 EMBARCADERO RD. SE DECISION MADE: 11-SEP-09 PALO ALTO CA 94303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT DIAGNOSTIC HYBRIDS, INC. 510(k) NO: K091171(TRADITIONAL)
ATTN: RONALD H LOLLAR PHONE NO : 740 589 3300 1055 EAST STATE STREET SUITE 100 SE DECISION MADE: 11-SEP-09 ATHENS OH 45701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CABLE READY CABLE GRIP SYSTEM CABLE BUTTON ZIMMER, INC. 510(k) NO: K091799(TRADITIONAL)
ATTN: ANTHONY FRANCALANCIA PHONE NO : 574 372 4570 P.O. BOX 708 SE DECISION MADE: 11-SEP-09 WARSAW IN 46581 0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIMMER CONTINUUM ACETABULAR SYSTEM, ZIMMER TRILOGY IT ACETABULAR SYSTEM ZIMMER, INC. 510(k) NO: K091508(TRADITIONAL)
ATTN: BENJAMIN C CURSON PHONE NO : 574 372 4119 P.O. BOX 708 SE DECISION MADE: 11-SEP-09 WARSAW IN 46581 0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY BACTERIN INTERNATIONAL INC. 510(k) NO: K091321(TRADITIONAL)
ATTN: HOWARD J SCHRAYER PHONE NO : 609 924 9510 600 CRUISER LN. SE DECISION MADE: 11-SEP-09 BELGRADE MT 59714 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEARTRAIL III GUIDING CATHETER TERUMO CORP. 510(k) NO: K092372(TRADITIONAL)
ATTN: MARK UNTERREINER PHONE NO : 410 392 7213 950 ELKTON BLVD. SE DECISION MADE: 11-SEP-09 ELKTON MD 21921 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TRU FLU, MODEL 751230 MERIDIAN BIOSCIENCE, INC. 510(k) NO: K092553(SPECIAL)
ATTN: SUSAN ROLIH PHONE NO : 513 271 3700 3471 RIVER HILLS DR. SE DECISION MADE: 11-SEP-09 CINCINNATI OH 45244 510(k) STATEMENT DEVICE: IST SNORING APPLIANCE DENTAL CRAFTERS 510(k) NO: K090911(TRADITIONAL)
ATTN: AMY NYSTROM PHONE NO : 715 387 2642 P.O. BOX 770 SE DECISION MADE: 11-SEP-09 MARSHFELD WI 54449 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: D-STAT RAD-BAND, RAD-BAND, MODELS 3501, 3505 VASCULAR SOLUTIONS, INC. 510(k) NO: K092612(SPECIAL)
ATTN: LISA GALLATIN PHONE NO : 763 656 4300 6464 SYCAMORE COURT SE DECISION MADE: 11-SEP-09 MINNEAPOLIS MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM, VERSION 1.1 SMITH & NEPHEW, INC. 510(k) NO: K092497(SPECIAL)
ATTN: REGINA HOLMES PHONE NO : 901 399 6538 1450 E BROOKS ROAD SE DECISION MADE: 11-SEP-09 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RUTTER SUPRA STOMAL STENTS BOSTON MEDICAL PRODUCTS, INC. 510(k) NO: K091135(TRADITIONAL)
ATTN: MICHAEL A WARREN PHONE NO : 508 898 9300 117 FLANDERS RD. SE DECISION MADE: 14-SEP-09 WESTBOROUGH MA 01581 510(k) STATEMENT DEVICE: GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW CO-LIGNE AG 510(k) NO: K083567(SPECIAL)
ATTN: DAVID W SCHLERF PHONE NO : 925 768 0247 1070 CONRAD AVENUE, SUITE 230 SE DECISION MADE: 14-SEP-09 CONCORD CA 94520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TSI; ERI OCO BIOMEDICAL 510(k) NO: K090174(TRADITIONAL)
ATTN: JACK BLOOM PHONE NO : 800 228 0477 8500 WASHINGTON ST. NE SUITE A-1 SE DECISION MADE: 14-SEP-09 ALBUQUERQUE NM 87113 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GRACE DYNAMIC TORP GRACE MEDICAL, INC. 510(k) NO: K091187(TRADITIONAL)
ATTN: JEFF COBB PHONE NO : 901 380 7000 8500 WOLF LAKE DR., STE. 110 SE DECISION MADE: 14-SEP-09 MEMPHIS TN 38133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM2031 SPINEFRONTIER, INC. 510(k) NO: K091638(ABBREVIATED)
ATTN: JOHN SULLIVAN PHONE NO : 978 232 3990 500 CUMMINGS CENTER, STE. 3500 SE DECISION MADE: 14-SEP-09 BEVERLY MA 01915 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER, MODEL S1PIC1.9-C FOOTPRINT MEDICAL 510(k) NO: K091488(TRADITIONAL)
ATTN: CLYDE BAKER PHONE NO : 210 226 2600 1203 CAMDEN ST. SE DECISION MADE: 14-SEP-09 SAN ANTONIO TX 78215 510(k) STATEMENT DEVICE: MODIFICATION TO: PSS SYSTEM SPINAL USA 510(k) NO: K092128(SPECIAL)
ATTN: JEFFREY JOHNSON PHONE NO : 601 420 4244 2050 EXECUTIVE DR. SE DECISION MADE: 14-SEP-09 PEARL MS 39208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K091968(TRADITIONAL)
ATTN: CRYSTAL DIZOL PHONE NO : 424 218 8381 2151 E. GRAND AVE. SE DECISION MADE: 14-SEP-09 EL SEGUNDO CA 90245 510(k) STATEMENT DEVICE: ETHICON ENDO-SURGERY LINEAR CUTTER 55MM (NTLC55),SELECTABLE CARTRIDGE 55 / 75MM (SR55/75) ,LINEAR CUTTER 75MM (NTLC75) ETHICON ENDO-SURGERY, LLC 510(k) NO: K092577(TRADITIONAL)
ATTN: ABHILASHA MUKHERJEE PHONE NO : 513 337 3623 4545 CREEK ROAD SE DECISION MADE: 15-SEP-09 CINCINNATI OH 45242 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BELTBEAT WF-400 BONUS COMMUNICACIONES SRL 510(k) NO: K083715(TRADITIONAL)
ATTN: BENNY ARAZY PHONE NO : 972 499 47880 INDUSTRIAL PARK 13 M.P. MISGAV SE DECISION MADE: 15-SEP-09 MIZPE AVIV IS 20184 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESTECH HAWKEYE INTRODUCER SYSTEMS ENDOSCOPIC TECHNOLOGIES, INC. D/B/510(k) NO: K091350(TRADITIONAL)
ATTN: TAMER IBRAHIM PHONE NO : 925 543 2110 2603 CAMINO RAMON SUITE 100 SE DECISION MADE: 15-SEP-09 SAN RAMON CA 94583 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STAT PACS PICTURE ARCHIVING & COMMUNICATION SYSTEM (PACS) STATRAD, LLC 510(k) NO: K092134(TRADITIONAL)
ATTN: PHONE NO : 4747 VIEWRIDGE AVE. SUITE 107 SE DECISION MADE: 15-SEP-09 SAN DIEGO CA 92123 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ESTEEM ORTHO POLYISOPRENE POWDER-FREE SURGICAL GLOVES CARDINAL HEALTH, INC. 510(k) NO: K092304(TRADITIONAL)
ATTN: TATYANA BOGDAN PHONE NO : 847 578 2325 1500 WAUKEGAN ROAD SE DECISION MADE: 15-SEP-09 MCGAW PARK IL 60085 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA ISOAID, L.L.C. 510(k) NO: K091117(TRADITIONAL)
ATTN: BENJAMIN ROEDELL PHONE NO : 727 815 3262 7824 CLARK MOODY BLVD. SE DECISION MADE: 15-SEP-09 PORT RICHEY FL 34668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUICKVUE INFLUENZA A+B TEST QUIDEL CORP. 510(k) NO: K092698(SPECIAL)
ATTN: JOHN D TAMERIUS PHONE NO : 858 552 7908 10165 MCKELLAR CT. SE DECISION MADE: 15-SEP-09 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM FLEXIBLE STENTING SOLUTIONS, INC. 510(k) NO: K081996(TRADITIONAL)
ATTN: JOSEPH C GRIFFIN PHONE NO : 732 578 0060 23 CHRISTOPHER WAY SE DECISION MADE: 15-SEP-09 EATONTOWN NJ 07724 510(k) STATEMENT DEVICE: MODEL 1014 PC ELECTROMETER SUN NUCLEAR CORP. 510(k) NO: K092019(TRADITIONAL)
ATTN: NOEL DOWNEY PHONE NO : 321 259 6862 425-A PINEDA COURT SE DECISION MADE: 15-SEP-09 MELBOURNE FL 32940 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES BEERE PRECISION MEDICAL INSTRUMENT510(k) NO: K092533(SPECIAL)
ATTN: JOY VOIGT PHONE NO : 262 925 8274 5307 95TH AVE. SE DECISION MADE: 15-SEP-09 KENOSHA WI 53144 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES, ORANGE (ORANGE SCENTED), WHITE (VANILLA SCENTED) GX CORPORATION SDN BHD 510(k) NO: K092200(TRADITIONAL)
ATTN: FOO KHON PU PHONE NO : 603 329 11600 LOT 6487A, BATU 5 3/4, SEMENTA JALSE DECISION MADE: 16-SEP-09 KLANG, SELANGOR DARUL EHSAN MY 510(k) STATEMENT DEVICE: M. DIOR BRAND SUZHOU COLOUR-WAY ENTERPRISE DEVEL510(k) NO: K083817(ABBREVIATED)
ATTN: CHU XIAOAN PHONE NO : 86 10 82387441 RM. 1606, BLDG. 1, JIANXIANG - YUASE DECISION MADE: 16-SEP-09 HAIDIAN DISTRICT, BEIJING CH 10510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES,MODEL 1000-01 TAB VARYING DIAMETERS, MEDSHAPE SOLUTIONS 510(k) NO: K091202(TRADITIONAL)
ATTN: JACK GRIFFIS PHONE NO : 404 249 9155 1575 NORTHSIDE DR. SUITE 440 SE DECISION MADE: 16-SEP-09 ATLANTA GA 30318 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACE SURGICAL SECURE- MINI LOCATOR IMPLANT SYSTEM, MODEL 09-2702-OX, 09-2703-OX, 09-2705-OX ACE SURGICAL SUPPLY CO., INC. 510(k) NO: K092594(SPECIAL)
ATTN: J.EDWARD CARCHIDI PHONE NO : 508 588 3100 1034 PEARL ST. SE DECISION MADE: 16-SEP-09 BROCKTON MA 02301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG ELEGANCE PLASTIC PROD510(k) NO: K092416(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 108 2387441 RM 1606 BLDG. 1 JIANXIANG YUAN NO.SE DECISION MADE: 16-SEP-09 HAIDIAN DISTRICT, BEIJING CH 10510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387 DANVILLE MATERIALS, INC. 510(k) NO: K092319(TRADITIONAL)
ATTN: CRAIG BRUNS PHONE NO : 925 973 0710 3420 FOSTORIA WAY, SUITE A-200 SE DECISION MADE: 16-SEP-09 SAN RAMON CA 94583 510(k) STATEMENT DEVICE: PRO-PICC MEDCOMP 510(k) NO: K091953(TRADITIONAL)
ATTN: JEAN CALLOW PHONE NO : 215 256 4201 1499 DELP DR. SE DECISION MADE: 16-SEP-09 HARLEYSVILLE PA 19438 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRO-PICC CT MEDCOMP 510(k) NO: K092347(SPECIAL)
ATTN: JEAN CALLOW PHONE NO : 215 256 4201 1499 DELP DR. SE DECISION MADE: 16-SEP-09 HARLEYSVILLE PA 19438 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASYRA GLU-H REAGENT, MODEL 10200 MEDICA CORP. 510(k) NO: K092506(SPECIAL)
ATTN: PHOTIOS MAKRIS PHONE NO : 781 725 4892 5 OAK PARK DRIVE SE DECISION MADE: 16-SEP-09 BEDFORD MA 01730 510(k) STATEMENT DEVICE: COBALT MV BONE CEMENT BIOMET MANUFACTURING CORP. 510(k) NO: K091608(TRADITIONAL)
ATTN: SUSAN ALEXANDER PHONE NO : 574 267 6639 56 EAST BELL DRIVE P.O. BOX 587 SE DECISION MADE: 17-SEP-09 WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMSCO EVOLUTION MEDIUM STEAM STERILIZER STERIS CORPORATION 510(k) NO: K091731(ABBREVIATED)
ATTN: ROBERT F SULLIVAN PHONE NO : 440 392 7695 5960 HEISLEY RD. SE DECISION MADE: 17-SEP-09 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESOPHAGEAL STETHOSCOPE TRUER MEDICAL INC. 510(k) NO: K092716(TRADITIONAL)
ATTN: TIM TRUITT PHONE NO : 714 628 9785 1050 N BATAVIA STREET SE DECISION MADE: 17-SEP-09 ORANGE CA 92867 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES TANGSHAN HONGXING PLASTIC PRODUCTS510(k) NO: K092100(TRADITIONAL)
ATTN: JOHN ZHAO PHONE NO : 909 548 4828 12390 EAST END AVE. SE DECISION MADE: 18-SEP-09 CHINO CA 91710 510(k) STATEMENT DEVICE: COLLAGEN DENTAL MEMBRANE IV COLLAGEN MATRIX, INC. 510(k) NO: K090216(TRADITIONAL)
ATTN: PEGGY HANSEN PHONE NO : 201 405 1477 509 COMMERCE ST. SE DECISION MADE: 18-SEP-09 FRANKLIN LAKES NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM ACCURAY, INC. 510(k) NO: K091999(SPECIAL)
ATTN: ANNE SCHLAGENHAFT PHONE NO : 408 716 4628 1310 CHESAPEAKE TERRACE SE DECISION MADE: 18-SEP-09 SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUNC IVF CENTERWELL AND ICSI DISHES THERMO FISHER SCIENTIFIC (NALGE NU510(k) NO: K090429(TRADITIONAL)
ATTN: ROBERT PRESCOTT PHONE NO : 585 586 8800 75 PANORAMA CREEK DRIVE SE DECISION MADE: 18-SEP-09 ROCHESTER NY 14625 2385 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE ETEX CORP. 510(k) NO: K090855(TRADITIONAL)
ATTN: CHRISTOPHER KLACZYK PHONE NO : 617 577 7270 38 SIDNEY ST. SE DECISION MADE: 18-SEP-09 CAMBRIDGE MA 02139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMO SCIENTIFIC CYTO-CAL COUNT TUBES MICROGENICS CORP. 510(k) NO: K090810(TRADITIONAL)
ATTN: LISA CHARTER PHONE NO : 510 979 5142 46360 FREMONT BLVD SE DECISION MADE: 18-SEP-09 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CFI ULTRASOUND PROBE DRAPE CONTOUR FABRICATORS, INC. 510(k) NO: K090773(TRADITIONAL)
ATTN: JOHN W SCHAEFER PHONE NO : 810 750 5300 14241 FENTON RD. SE DECISION MADE: 18-SEP-09 FENTON MI 48430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT GISH BIOMEDICAL, INC. 510(k) NO: K090449(TRADITIONAL)
ATTN: JANET PEETS PHONE NO : 949 635 6240 22942 ARROYO VISTA SE DECISION MADE: 18-SEP-09 RANCHO SANTA MARGARITA CA 92688 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT GISH BIOMEDICAL, INC. 510(k) NO: K090450(TRADITIONAL)
ATTN: JANET PEETS PHONE NO : 949 635 6240 22942 ARROYO VISTA SE DECISION MADE: 18-SEP-09 RANCHO SANTA MARGARITA CA 92688 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MARKSMANN CATHETER CHESTNUT MEDICAL TECHNOLOGIES, INC510(k) NO: K091559(TRADITIONAL)
ATTN: DANIEL CHER PHONE NO : 650 566 0057 173 JEFFERSON DRIVE SE DECISION MADE: 18-SEP-09 MENLO PARK CA 94025 1114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL LTX240AA01-A SAMSUNG MOBILE DISPLAY CO., LTD 510(k) NO: K090742(TRADITIONAL)
ATTN: VINCENT LEE PHONE NO : 281 598 8110 256 NORTH SAM HOUSTON PKWY E #115 SE DECISION MADE: 18-SEP-09 HOUSTON TX 77060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SINGLE USE SPLINTING TUBE, MODELS ST-Y0002-S, ST-Y0002-H, ST-Y0003-S AND ST-Y0003-H OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K091759(TRADITIONAL)
ATTN: STACY ABBATIELLO KLUESNER PHONE NO : 484 896 5405 3500 CORPORATE PARKWAY PO BOX 610 SE DECISION MADE: 18-SEP-09 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIGHTLAS MODEL 532 LIGHTMED CORP. 510(k) NO: K091534(TRADITIONAL)
ATTN: ANITA CHEN PHONE NO : 886 226 881726 NO.1-1, LANE1,PAO-AN ST. SEC.3 SHUSE DECISION MADE: 18-SEP-09 TAIPEI TW 238 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIANA FUSION CAGE SIGNUS MEDICAL 510(k) NO: K091122(TRADITIONAL)
ATTN: RICHARD JANSEN PHONE NO : 202 552 5800 1331 H STREET NW SUITE 1200 SE DECISION MADE: 18-SEP-09 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLOOD GLUCOSE MONITORING SYSTEM, MODEL FORA G90/TD-4234 TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K091898(SPECIAL)
ATTN: ERICA LI PHONE NO : 886 2 66258188 6F, NO. 127, WUGONG 2ND RD WUGU TOSE DECISION MADE: 18-SEP-09 TAIPEI COUNTY TW 24888 510(k) STATEMENT DEVICE: POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES SHANGDONG ZIBO SHANCHUAN MEDICAL I510(k) NO: K092000(TRADITIONAL)
ATTN: JOHN ZHAO PHONE NO : 909 548 4828 12390 EAST END AVE. SE DECISION MADE: 18-SEP-09 CHINO CA 91710 510(k) STATEMENT DEVICE: POGO SCREW FXDEVICES 510(k) NO: K092189(SPECIAL)
ATTN: RICH LIPSCHUTZ PHONE NO : 561 394 6501 ONE SOUTH OCEAN BLVD. SE DECISION MADE: 18-SEP-09 BOCA RATON FL 33432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL BLOOD PRESSURE MONITOR SHANGHAI LITTLE DOCTOR ELECTRONIC 510(k) NO: K092719(TRADITIONAL)
ATTN: SELINA QIAN PHONE NO : 513 859 86717 NO.8 TONGXING ROAD, NANTONG ECONOMSE DECISION MADE: 18-SEP-09 NANTONG, JIANGSU CH 226007 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: 160MLC OPTION SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K092145(TRADITIONAL)
ATTN: CHRISTINE DUNBAR PHONE NO : 925 602 8157 4040 NELSON AVE. SE DECISION MADE: 18-SEP-09 CONCORD CA 94520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8 MEDCOM GMBH 510(k) NO: K092653(SPECIAL)
ATTN: STEFAN WALTER PHONE NO : 49 615 19514717 12 RUNDETURMSTRASSE SE DECISION MADE: 18-SEP-09 DARMSTADT, HESSEN GM 64283 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COPRAN ZR/ORIGIN YZ WHITE PEAKS DENTAL SYSTEMS GMBH & 510(k) NO: K092496(TRADITIONAL)
ATTN: OLIVER PUCKERT PHONE NO : 49 281 20645812 LANGHEIDE 9 SE DECISION MADE: 18-SEP-09 ESSEN GM 45239 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: OMNIPRO INCLINE IBA DOSIMETRY GMBH 510(k) NO: K092018(TRADITIONAL)
ATTN: CHUCK LINDLEY PHONE NO : 901 386 2242 3150 STAGE POST DR SUITE 110 SE DECISION MADE: 18-SEP-09 BARTLETT TN 38133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRYPTIK CA ANTERIOR INTERSOMATIC CERVICAL CAGE, MODELS MOS-CA 12 05-S, MOS-CA 12 O6-S SPINEART 510(k) NO: K091873(ABBREVIATED)
ATTN: FRANCK PENNESI PHONE NO : 412 279 94025 COINTRIN 20 ROUTE DE PRE-BOIS CP18SE DECISION MADE: 18-SEP-09 GENEVA SZ 1215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LED CURING LIGHT, MODEL GT-1500 MONITEX INDUSTRIAL CO., LTD. 510(k) NO: K091887(TRADITIONAL)
ATTN: SHU-LUNG WANG PHONE NO : 886 229 993869 6F, 70 SEC. 1 GUANG-FU ROAD SE DECISION MADE: 18-SEP-09 SAN-CHUNG CITY TW 241-58 510(k) STATEMENT DEVICE: ABVS WORKPLACE SIEMENS AG, MEDICAL SOLUTIONS 510(k) NO: K092067(TRADITIONAL)
ATTN: SHELLY PEARCE PHONE NO : HENESTRASSE 127 SE DECISION MADE: 18-SEP-09 ERLANGEN GM D-91052 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS HOSPIRA, INC. 510(k) NO: K091268(SPECIAL)
ATTN: DANIELA WEKSLER PHONE NO : 224 212 5316 275 NORTH FIELD DR. SE DECISION MADE: 18-SEP-09 LAKE FOREST IL 60045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XPERT HEMOSIL FACTOR II & FACTOR V ASSAY CEPHEID 510(k) NO: K082118(TRADITIONAL)
ATTN: RUSSEL K ENNS PHONE NO : 408 400 8230 904 CARIBBEAN DRIVE SE DECISION MADE: 18-SEP-09 SUNNYVALE CA 94089 1189 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS FHC, INC. 510(k) NO: K092562(SPECIAL)
ATTN: LEE D MARGOLIN PHONE NO : 207 666 5651 1201 MAIN ST SE DECISION MADE: 18-SEP-09 BOWDOIN ME 04287 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES ZIBO INTCO MEDICAL PRODUCTS CO., L510(k) NO: K091942(TRADITIONAL)
ATTN: JOHN ZHAO PHONE NO : 909 548 4828 12390 EAST END AVE. SE DECISION MADE: 21-SEP-09 CHINO CA 91710 510(k) STATEMENT DEVICE: HEALTHANYWHERE SYSTEM HEALTHANYWHERE, AN IGEACARE SYSTEM510(k) NO: K091220(TRADITIONAL)
ATTN: SHAWN SLADE PHONE NO : 613 271 0283 515 LEGGET DRIVE SUITE 700 SE DECISION MADE: 21-SEP-09 OTTAWA CA K2K 3G4 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INJECTAFIL APEX DENTAL MATERIALS, INC. 510(k) NO: K091647(TRADITIONAL)
ATTN: CHRIS KULTON PHONE NO : 877 273 9123 330 TELSER ROAD SE DECISION MADE: 21-SEP-09 LAKE ZURICH IL 60047 510(k) STATEMENT DEVICE: RASCAL "WE GO 250" POWERED WHEELCHAIR ELECTRIC MOBILITY CORP. 510(k) NO: K092130(ABBREVIATED)
ATTN: W. STEPHEN BEVERSLUIS PHONE NO : 856 468 1000 1 MOBILITY PLAZA SE DECISION MADE: 21-SEP-09 SEWELL NJ 08080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BELLUS SHADING KIT 3M ESPE AG DENTAL PRODUCTS 510(k) NO: K090718(TRADITIONAL)
ATTN: DESI W SOEGIARTO PHONE NO : 49 815 27001169 ESPE PLATZ SE DECISION MADE: 21-SEP-09 SEEFELD, BAVARIA GM D-82229 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEARTWAY POWER MOBILITY SCOOTER, S9 HEARTWAY MEDICAL PRODUCTS CO., LTD510(k) NO: K092154(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 352 08829 NO.58, FU-CHIUN ST. SE DECISION MADE: 21-SEP-09 HSIN-CHU CITY TW 408 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158 MICROGENICS CORP. 510(k) NO: K092051(TRADITIONAL)
ATTN: LISA CHARTER PHONE NO : 510 979 5142 46360 FREMONT BLVD SE DECISION MADE: 21-SEP-09 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEARTWAY POWER MOBILITY SCOOTER, S8 HEARTWAY MEDICAL PRODUCTS CO., LTD510(k) NO: K092155(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 352 08829 NO.58, FU-CHIUN ST. SE DECISION MADE: 21-SEP-09 HSIN-CHU CITY TW 408 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERSONAL WHEEZOMETER KARMELSONIX 510(k) NO: K090863(TRADITIONAL)
ATTN: YORAM LEVY PHONE NO : 972 463 88837 31 HAAVODA ST. SE DECISION MADE: 21-SEP-09 BINYAMINA IS 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TORNIER, PITON FIXATION IMPLANT SYSTEM TORNIER 510(k) NO: K091870(TRADITIONAL)
ATTN: HOWARD L SCHRAYER PHONE NO : 609 924 9510 100 CUMMINGS CENTER SUITE 444C SE DECISION MADE: 21-SEP-09 BEVERLY MA 01915 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: T2 SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K091883(TRADITIONAL)
ATTN: THERESA LEISTER PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 21-SEP-09 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054; (PENUMBRA SEPARATOR 054), MODEL PSS054 PENUMBRA, INC. 510(k) NO: K090752(TRADITIONAL)
ATTN: LOUISE MUSANTE PHONE NO : 510 748 3247 1351 HARBOR BAY PKWY. SE DECISION MADE: 21-SEP-09 ALAMEDA CA 94502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLOOD PRESSURE MONITOR, MODEL WA400 FOR WRIST TYPE AND MODEL AA300 FOR UPPER ARM TYPE NINGBO DIAIER ELECTRONIC CO., LTD.510(k) NO: K091553(TRADITIONAL)
ATTN: LAO XIKUN PHONE NO : 057 462 463008 NO. 1 BEIXING ROAD YAOXI INDUSTRIASE DECISION MADE: 21-SEP-09 YUYAO CITY, ZHEJIANG CH 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: X-CUBE SAESHIN PRECISION CO., LTD. 510(k) NO: K092758(TRADITIONAL)
ATTN: Y.S. LEE PHONE NO : 82 53 5872345 #93-15, PAHO-DONG, DALSEO-GU SE DECISION MADE: 21-SEP-09 DAEGU KS 704-220 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MICRO-TOUCH NITRA FREE ANSELL HEALTHCARE PRODUCTS LLC 510(k) NO: K092327(ABBREVIATED)
ATTN: CYNTHIA A INGRAM PHONE NO : 334 615 2563 1635 INDUSTRIAL RD. SE DECISION MADE: 21-SEP-09 DOTHAN AL 36303 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014 NSPIRE HEALTH, INC. 510(k) NO: K091853(TRADITIONAL)
ATTN: KIMBERLY STARK PHONE NO : 303 666 5555 1830 LEFTHAND CIRCLE SE DECISION MADE: 21-SEP-09 LONGMONT CO 80501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE SPO2 SENSOR M1134A PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K091572(TRADITIONAL)
ATTN: JENS-PETER SEHER PHONE NO : 497 031 4632086 HEWLETT-PACKARD STR.2 SE DECISION MADE: 22-SEP-09 BOEBLINGEN GM D 71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MRI NEURO DRAPE SURGIVISION, INC. 510(k) NO: K091343(TRADITIONAL)
ATTN: J. HARVEY KNAUSS PHONE NO : 713 723 4080 11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 22-SEP-09 HOUSTON TX 77071 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXTEND FRAME SYSTEM, MODEL 1009633 ELEKTA INSTRUMENT AB 510(k) NO: K092083(TRADITIONAL)
ATTN: ABDERS SKOGLUND PHONE NO : 468 587 25400 KUNGSTENSGATAN 18 P.O.BOX 7593 SE DECISION MADE: 22-SEP-09 STOCKHOLM SW S-103 93 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOBELPROCERA TI ABUTMENT NOBEL BIOCARE AB 510(k) NO: K091756(TRADITIONAL)
ATTN: HERBERT CRANE PHONE NO : 714 282 4800 22715 SAVI RANCH PKWY. SE DECISION MADE: 22-SEP-09 YORBA LINDA CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASTRA TECH IMPLANT SYSTEM ASTRA TECH AB 510(k) NO: K091239(TRADITIONAL)
ATTN: LINDA K SCHULZ PHONE NO : 858 792 1235 11234 EL CAMINO REAL, SUITE 200 SE DECISION MADE: 22-SEP-09 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM NEUSOFT MEDICAL SYSTEMS CO., LTD. 510(k) NO: K092742(TRADITIONAL)
ATTN: TIAN YANGFANG PHONE NO : 862 483 660649 NO.3-11, WENHUA ROAD HEPING DISTRISE DECISION MADE: 22-SEP-09 SHENYANG, LIAONING CH 110004 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: ACL TOP 700 LAS INSTRUMENTATION LABORATORY CO. 510(k) NO: K091980(SPECIAL)
ATTN: CAROL MARBLE PHONE NO : 781 861 4467 113 HARTWELL AVE. SE DECISION MADE: 22-SEP-09 LEXINGTON MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315 EV3 NEUROVASCULAR 510(k) NO: K092495(SPECIAL)
ATTN: LAURIE E CARTWRIGHT PHONE NO : 949 837 3700 9775 TOLEDO WAY SE DECISION MADE: 22-SEP-09 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM AESCULAP IMPLANT SYSTEMS, INC. 510(k) NO: K092143(SPECIAL)
ATTN: KATHY A RACOSKY PHONE NO : 610 984 9291 3773 CORPORATE PWKY. SE DECISION MADE: 22-SEP-09 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIPOEZE LASER ASSISTED ASPIRATION CANNULA CURVE MEDICAL 510(k) NO: K091800(TRADITIONAL)
ATTN: F. DAVID ROTHKOPF PHONE NO : 508 231 8842 200 HOMER AVE. SE DECISION MADE: 23-SEP-09 ASHLAND MA 01721 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARIAX ELBOW SYSTEM LINE EXTENSION HOWMEDICA OSTEONICS CORP. 510(k) NO: K092671(SPECIAL)
ATTN: MELISSA A MATARESE PHONE NO : 201 831 5116 325 CORPORATE DRIVE SE DECISION MADE: 23-SEP-09 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BELIMED STEAM STERILIZER TOP 5000, SERIES 8, MODELS: 6-0-12 VS1 AND VS2 BELIMED SAUTER AG 510(k) NO: K090339(TRADITIONAL)
ATTN: CHRIS P MANNARINO PHONE NO : 843 216 7424 2284 CLEMENTS FERRY RD. SE DECISION MADE: 23-SEP-09 CHARLESTON SC 29412 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES ZOLL MEDICAL CORP. 510(k) NO: K090989(TRADITIONAL)
ATTN: CHARLES W KOLIFRATH PHONE NO : 978 421 9786 269 MILL ROAD SE DECISION MADE: 23-SEP-09 CHELMSFORD MA 01824 4105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM, MODEL TRS100SB ANCHOR PRODUCTS CO. 510(k) NO: K091930(SPECIAL)
ATTN: GARY S THRUN PHONE NO : 630 543 9124 52 OFFICIAL RD. SE DECISION MADE: 23-SEP-09 ADDISON IL 60101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VESOCCLUDE LIGATING CLIP VESOCCLUDE MEDICAL, LLC 510(k) NO: K091060(TRADITIONAL)
ATTN: DIANE N PEPER PHONE NO : 919 435 5409 10419 STALLINGS ROAD SE DECISION MADE: 23-SEP-09 SPRING HOPE NC 27882 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APTUS K-WIRE SYSTEM MEDARTIS AG 510(k) NO: K092038(TRADITIONAL)
ATTN: KEVIN THOMAS PHONE NO : 858 792 1235 11234 EL CAMINO REAL, STE 200 SE DECISION MADE: 23-SEP-09 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO7 AND L-ANEO7A SOFTWARE USING F-CU8 OR F-CU5 (P) MONITOR FRAME OPTIONS AN GE HEALTHCARE FINLAND OY 510(k) NO: K092680(SPECIAL)
ATTN: RAUNO RUOHO PHONE NO : 358 103 9411 KUORTANEENKATU 2 SE DECISION MADE: 23-SEP-09 HELSINKI FI FIN-00510 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAURIMED SPINAL INJECTION SYSTEM LAURIMED LLC 510(k) NO: K091818(SPECIAL)
ATTN: SEVRINA CIUCCI PHONE NO : 408 316 4837 500 ARGUELLO STREET, SUITE 100 SE DECISION MADE: 23-SEP-09 REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MILSCOPE FLOATING MASS STETHOSCOPE, MODEL 300-01 STETHOSCOPE TECHNOLOGIES, INC 510(k) NO: K091972(TRADITIONAL)
ATTN: DAVID STARK PHONE NO : 415 888 3700 38 MILLER AVE PMB 170 SE DECISION MADE: 23-SEP-09 MILL VALLEY CA 94941 510(k) STATEMENT DEVICE: NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000 NEXGEN MEDICAL SYSTEMS, INC. 510(k) NO: K090932(TRADITIONAL)
ATTN: JOHN KUCHARCZYK PHONE NO : 775 851 7337 10471 DOUBLE R BLVD. SUITE C SE DECISION MADE: 24-SEP-09 RENO NV 89521 510(k) STATEMENT DEVICE: PACSCAN PLUS, MODELS 300P AND 300AP SONOMED, INC. 510(k) NO: K092637(SPECIAL)
ATTN: CHARLES C O'NEAL PHONE NO : 516 354 0900 1979 MARCUS AVE. SUITE 105C SE DECISION MADE: 24-SEP-09 LAKE SUCCESS NY 11040 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XIO RTP SYSTEM COMPUTERIZED MEDICAL SYSTEMS, INC.510(k) NO: K092132(TRADITIONAL)
ATTN: KATHRYN STINSON PHONE NO : 314 993 0003 13723 RIVERPORT DR SUITE 100 SE DECISION MADE: 24-SEP-09 MARYLAND HEIGHTS MO 63043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO BEACON STABILIZATION SYSTEM GLOBUS MEDICAL, INC. 510(k) NO: K092610(SPECIAL)
ATTN: KELLY J BAKER PHONE NO : 610 415 9000 2560 GENERAL ARMISTEAD AVE. VALLEYSE DECISION MADE: 24-SEP-09 AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS PROCTER & GAMBLE CO. 510(k) NO: K091964(TRADITIONAL)
ATTN: VICTORIA P SCHOFIELD PHONE NO : 513 622 4851 8700 MASON-MONTGOMERY RD. SE DECISION MADE: 24-SEP-09 MASON OH 45040 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RP CUTTING NEEDLE RIVERPOINT MEDICAL 510(k) NO: K092059(TRADITIONAL)
ATTN: DOUG ROWLEY PHONE NO : 503 517 8001 825 NE 25TH AVE. SE DECISION MADE: 24-SEP-09 PORTLAND OR 97232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASCAL STREAMLINE PHOTOCOAGULATOR OPTIMEDICA CORPORATION 510(k) NO: K092621(SPECIAL)
ATTN: DARLENE CROCKETT-BILLIG PHONE NO : 408 400 0856 155-A MOFFETT PARK DRIVE SUITE 210SE DECISION MADE: 25-SEP-09 SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIREBIRD SPINAL FIXATION SYSTEM BLACKSTONE MEDICAL, INC. 510(k) NO: K092624(SPECIAL)
ATTN: WHITNEY G TORNING PHONE NO : 973 496 2838 1211 HAMBURG TURNPIKE SUITE 300 SE DECISION MADE: 25-SEP-09 WAYNE NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES TANGSHAN DAR PLASTIC & RUBBER PROD510(k) NO: K082648(TRADITIONAL)
ATTN: WANG JINCHENG PHONE NO : 86 315 5028910 RM.1606 BLDG.1 JIANXIANG YUAN NO.2SE DECISION MADE: 25-SEP-09 BEIJING CH 10083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOMET MODULAR FEMORAL REVISION SYSTEM BIOMET, INC. 510(k) NO: K090757(TRADITIONAL)
ATTN: BECKY EARL PHONE NO : 574 267 6639 56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 25-SEP-09 WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONDUCTOR CORONARY GUIDEWIRE CONCERT MEDICAL, LLC 510(k) NO: K090193(TRADITIONAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978 772 3552 5 WHITCOMB AVENUE SE DECISION MADE: 25-SEP-09 AYER MA 01432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALPHA DUO LAP INSUFFLATOR HIPPOKRATEC GMBH 510(k) NO: K090652(TRADITIONAL)
ATTN: CHRISTIAN SIEDERSBERGER PHONE NO : 49 802 5286680 AM WINDFELD 36 SE DECISION MADE: 25-SEP-09 MIEBACH, BAVARIA GM 83714 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SONOWAND INVITE SONOWAND AS 510(k) NO: K083597(TRADITIONAL)
ATTN: CONSTANCE G BUNDY PHONE NO : 763 574 1976 435 RICE CREEK TERRACE SE DECISION MADE: 25-SEP-09 FRIDLEY MN 55432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35 AXIS-SHIELD DIAGNOSTICS, LTD. 510(k) NO: K083868(TRADITIONAL) ATTN: CLAIRE DORA PHONE NO : 441 382 422000 THE TECHNOLOGY PARK SE DECISION MADE: 25-SEP-09 DUNDEE, SCOTLAND UK DD2 1XA 510(k) STATEMENT DEVICE: ELEGANT 3M ESPE AG DENTAL PRODUCTS 510(k) NO: K091826(TRADITIONAL)
ATTN: DESI W SOEGIARTO PHONE NO : 49 815 27001169 ESPE PLATZ SE DECISION MADE: 25-SEP-09 SEEFELD, BAVARIA GM D-82229 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HI-TORQUE PROGRESS GUIDE WIRE FAMILY ABBOTT VASCULAR INC. 510(k) NO: K091825(TRADITIONAL)
ATTN: MICHELE WALZ PHONE NO : 951 914 3246 41888 MOTOR CAR PARKWAY SE DECISION MADE: 25-SEP-09 TEMECULA CA 92591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL COMPONENT MAXX ORTHOPEDICS, INC. 510(k) NO: K091280(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508 643 0434 49 PLAIN ST. SE DECISION MADE: 25-SEP-09 NORTH ATTLEBORO MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECYS ANTI-CCP CALCHECK ROCHE DIAGNOSTICS CORP. 510(k) NO: K091601(TRADITIONAL)
ATTN: SARAH BAUMANN PHONE NO : 317 521 3952 9115 HAGUE RD. BOX 50410 SE DECISION MADE: 25-SEP-09 INDIANAPOLIS IN 46250 0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN FOOTPRINT MEDICAL 510(k) NO: K091213(TRADITIONAL)
ATTN: CLYDE BAKER PHONE NO : 210 226 2600 1203 CAMDEN ST. SE DECISION MADE: 25-SEP-09 SAN ANTONIO TX 78215 510(k) STATEMENT DEVICE: FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER FOOTPRINT MEDICAL 510(k) NO: K091214(TRADITIONAL)
ATTN: CLYDE BAKER PHONE NO : 210 226 2600 1203 CAMDEN ST. SE DECISION MADE: 25-SEP-09 SAN ANTONIO TX 78215 510(k) STATEMENT DEVICE: DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANT S & C POLYMER GMBH 510(k) NO: K091735(TRADITIONAL)
ATTN: CHRISTIAN BOETTCHER PHONE NO : 49 412 14830 ROBERT-BOSCH-STRASSE 5 SE DECISION MADE: 25-SEP-09 ELMSHORN GM D-25335 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KNEEALIGN SYSTEM ORTHALIGN, INC 510(k) NO: K091411(TRADITIONAL)
ATTN: AMY WALTERS PHONE NO : 949 923 9400 338 VISTA MADERA SE DECISION MADE: 25-SEP-09 NEWPORT BEACH CA 92660 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPI CUSTOMIZABLE GINGIVA FORMER THOMMEN MEDICAL, AG 510(k) NO: K092248(SPECIAL)
ATTN: LINDA K SCHULZ PHONE NO : 858 792 1235 11234 EL CAMINO REAL, SUITE 200 SE DECISION MADE: 25-SEP-09 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. 510(k) NO: K092626(SPECIAL)
ATTN: FRANK JURCZAK PHONE NO : 508 828 3288 325 PARAMOUNT DR. SE DECISION MADE: 25-SEP-09 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SNM FIRMGRIP FLEXICATH LTD. 510(k) NO: K092629(SPECIAL)
ATTN: TALI HAZAN PHONE NO : 972 775 055525 120 YIGAL ALON ST., SUITE 107 SE DECISION MADE: 25-SEP-09 TEL AVIV IS 67443 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES LOCKING HAND PLATES SYNTHES (USA) 510(k) NO: K092247(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610 719 6940 1301 GOSHEN PKWY. SE DECISION MADE: 25-SEP-09 WEST CHESTER PA 19380 510(k) STATEMENT DEVICE: OSOM INFLUENZA A&B TEST , MODEL PN190 GENZYME CORPORATION 510(k) NO: K092633(SPECIAL)
ATTN: FIL BUENVIAJE PHONE NO : 858 777 2611 500 KENDALL STREET SE DECISION MADE: 25-SEP-09 CAMBRIDGE MA 02142 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX STRYKER SPINE 510(k) NO: K091946(TRADITIONAL)
ATTN: KIMBERLY LANE PHONE NO : 201 760 8215 2 PEARL COURT SE DECISION MADE: 25-SEP-09 ALLENDALE NJ 07401 1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SCREW SYNTHES (USA) 510(k) NO: K092646(TRADITIONAL)
ATTN: KARL J NITTINGER PHONE NO : 610 719 6941 1301 GOSHEN PKWY. SE DECISION MADE: 25-SEP-09 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG ELEGANCE PLASTIC PROD510(k) NO: K092415(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 108 2387441 RM 1606 BLDG. 1 JIANXIANG YUAN NO.SE DECISION MADE: 25-SEP-09 HAIDIAN DISTRICT, BEIJING CH 10510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MANTIS REDUX SPINAL SYSTEM STRYKER SPINE 510(k) NO: K092631(SPECIAL)
ATTN: CURTIS D TRUESDALE PHONE NO : 201 760 8296 2 PEARL COURT SE DECISION MADE: 25-SEP-09 ALLENDALE NJ 07401 1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70 PRIMED MEDICAL PRODUCTS INC. 510(k) NO: K092012(SPECIAL)
ATTN: RAYMOND MARUSYK PHONE NO : 780 497 7600 SUITE 900, 10707-100 AVE. SE DECISION MADE: 25-SEP-09 EDMONTON, ALBERTA CA T5J 3M1 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOBELPROCERA ZI ABUTMENT NOBEL BIOCARE AB 510(k) NO: K091904(TRADITIONAL)
ATTN: HERBERT CRANE PHONE NO : 714 282 4800 22715 SAVI RANCH PKWY. SE DECISION MADE: 25-SEP-09 YORBA LINDA CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LD 1143 SHANGHAI LITTLE DOCTOR CO. LIMITED510(k) NO: K092683(SPECIAL)
ATTN: JANUSUN WANG PHONE NO : 86 513 85986718 NO. 8 TONGXING ROAD SE DECISION MADE: 25-SEP-09 NANTONG, JIANGSU CH 26007 510(k) STATEMENT DEVICE: HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON COOK ENDOSCOPY 510(k) NO: K090183(SPECIAL)
ATTN: TIFFANNY THOMAS PHONE NO : 336 744 0157 4900 BETHANIA STATION RD. SE DECISION MADE: 25-SEP-09 WINSTON-SALEM NC 27105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINAL USA INTERBODY CAGES SPINAL USA 510(k) NO: K092193(TRADITIONAL)
ATTN: JEFFREY JOHNSON PHONE NO : 601 420 4244 2050 EXECUTIVE DR. SE DECISION MADE: 25-SEP-09 PEARL MS 39208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE MSI MEDSERV INTERNATIONAL DEUTSCHL510(k) NO: K083840(TRADITIONAL)
ATTN: CHRISTINE STROBEL PHONE NO : 497 552 936570 ESCAD-STR 3 SE DECISION MADE: 28-SEP-09 PFULLENDORF GM D-88630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM GIVEN IMAGING LTD. 510(k) NO: K090557(TRADITIONAL)
ATTN: TIM THOMAS PHONE NO : 972 490 97936 NEW INDUSTRIAL PARK P.O. BOX 258 SE DECISION MADE: 28-SEP-09 YOQNEAM IS 20692 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KAINOS+ SIGNUS MEDIZINTECHNIK GMBH 510(k) NO: K090387(TRADITIONAL)
ATTN: KAREN WARDEN PHONE NO : 440 729 8457 8202 SHERMAN ROAD SE DECISION MADE: 28-SEP-09 CHSETERLAND OH 44026 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHEATHESISO ULTRASOUND TRANSDUCER COVER SHEATHING TECHNOLOGIES, INC. 510(k) NO: K091828(TRADITIONAL)
ATTN: JENNIFER DOWNING PHONE NO : 408 778 8523 18431 TECHNOLOGY DR. SE DECISION MADE: 28-SEP-09 MORGAN HILL CA 95037 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015 TRANSENTERIX, INC. 510(k) NO: K091697(TRADITIONAL)
ATTN: TAMMY CARREA PHONE NO : 919 541 9977 3908 PATRIOT DRIVE STE 170 SE DECISION MADE: 28-SEP-09 DURHAM NC 27703 510(k) STATEMENT DEVICE: SPINEWAND SURGICAL DEVICE ARTHROCARE CORP. 510(k) NO: K091228(SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408 736 0224 680 VAQUEROS AVE. SE DECISION MADE: 28-SEP-09 SUNNYVALE CA 94085 3523 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER LIGHTMED CORP. 510(k) NO: K091981(TRADITIONAL)
ATTN: ANITA CHEN PHONE NO : 866 2 26881726 NO.1-1, LANE1,PAO-AN ST. SEC.3 SHUSE DECISION MADE: 28-SEP-09 TAIPEI TW 238 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DBX DEMINERALIZED BONE MATRIX PUTTY MUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K091218(TRADITIONAL)
ATTN: NANCY BENNEWITZ JOY PHONE NO : 732 661 2381 125 MAY STREET SE DECISION MADE: 28-SEP-09 EDISON NJ 08837 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST SUNRISE MEDICAL 510(k) NO: K091919(TRADITIONAL)
ATTN: BETTY L MILLER PHONE NO : 814 443 7602 100 DEVILBISS DR. SE DECISION MADE: 28-SEP-09 SOMERSET PA 15501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S8 ASPEN WITH H4I PLUS RESMED LTD. 510(k) NO: K091947(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858 836 5984 9001 SPECTRUM CENTER BLVD. SE DECISION MADE: 28-SEP-09 BELLA VISTA CA 92123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM GE VINGMED ULTRASOUND AS 510(k) NO: K092756(TRADITIONAL)
ATTN: JAN T THOLLEFSEN PHONE NO : STRANDPROMENADEN 45 SE DECISION MADE: 28-SEP-09 HORTEN NO N-3183 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-HIP MAKO SURGICAL CORP. 510(k) NO: K091998(TRADITIONAL)
ATTN: WILLIAM TAPIA PHONE NO : 954 927 2044 2555 DAVIE RD., SUITE 110 SE DECISION MADE: 28-SEP-09 FT. LAUDERDALE FL 33317 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IROOT BP PLUS INNOVATIVE BIOCERAMIX INC. 510(k) NO: K092715(SPECIAL)
ATTN: QUANZU YANG PHONE NO : 604 221 6800 1628 WEST 75TH AVE. SE DECISION MADE: 28-SEP-09 VANCOUVER, BC CA V6P 6G2 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M) TRUMPF MEDIZIN SYSTEME GMBH + CO. 510(k) NO: K091246(ABBREVIATED)
ATTN: LINDSEY HENGEL PHONE NO : 843 416 1376 415 JESSEN LN. SE DECISION MADE: 28-SEP-09 CHARLESTON SC 29492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT FOR NOBEL REPLACE IMPLANTS, ATLANTIS GEMINI + ABUTMENT FOR NOBEL ASTRA TECH, INC. 510(k) NO: K091920(TRADITIONAL)
ATTN: BETSY A BROWN PHONE NO : 847 560 4406 8944 TAMAROA TERR. SE DECISION MADE: 28-SEP-09 SKOKIE IL 60076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNERGY INNERSPACE, INC. 510(k) NO: K083378(SPECIAL)
ATTN: DON BOBO PHONE NO : 714 859 7900 1622 EDINGER AVENUE, SUITE C SE DECISION MADE: 29-SEP-09 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOSAFE-REFLEX SAFETY HUBER INFUSION SET, AUTOSAFE ADVANTAGE SAFETY HUBER INFUSION SET AUTOSAFE-REFLEX INC. 510(k) NO: K090117(ABBREVIATED)
ATTN: JOHN STEPHENS PHONE NO : 770 740 0155 1025 NINE N. DR. SUITE K SE DECISION MADE: 29-SEP-09 ALPHARETTA GA 30004 510(k) STATEMENT DEVICE: PERIMETER INTERBODY FUSION DEVICE MEDTRONIC SOFAMOR DANEK 510(k) NO: K090353(TRADITIONAL)
ATTN: LEE GRANT PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 29-SEP-09 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HS AMICA H.S HOSPITAL SERVICE S.P.A. 510(k) NO: K083157(TRADITIONAL)
ATTN: LUCIO IMPROTA PHONE NO : 561 443 3321 6600 W. ROGERS CIRCLE SUITES 1 & 2SE DECISION MADE: 29-SEP-09 BOCA RATON FL 33487 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 CORPAK MEDSYSTEMS 510(k) NO: K091637(TRADITIONAL) ATTN: STEPHANIE WASIELEWSKI PHONE NO : 847 403 3484 100 CHADDICK DR. SE DECISION MADE: 29-SEP-09 WHEELING IL 60090 510(k) STATEMENT DEVICE: JOURNEY BCS KNEE SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K091014(TRADITIONAL)
ATTN: JASON SELLS PHONE NO : 901 399 5520 1450 BROOKS RD. SE DECISION MADE: 29-SEP-09 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4 GYRUS ACMI, INC. 510(k) NO: K092278(TRADITIONAL)
ATTN: GRAHAM A.L. BAILLIE PHONE NO : 508 804 2738 136 TURNPIKE RD. SE DECISION MADE: 29-SEP-09 SOUTHBOROUGH MA 01772 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AADVA ZR COLORING LIQUID GC AMERICA INC. 510(k) NO: K092020(TRADITIONAL)
ATTN: MARK HEISS PHONE NO : 708 597 0900 3737 WEST 127TH STREET SE DECISION MADE: 29-SEP-09 ALSIP IL 60803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL GDCH-2000 GLOBAL DENTAL DIRECT, INC. 510(k) NO: K092851(TRADITIONAL)
ATTN: DON TEMPLE PHONE NO : 604 557 1150 2120 PARAMOUNT CRESCENT SUITE 4 SE DECISION MADE: 29-SEP-09 ABBOTSFORD, BC CA V2T-6A5 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200 LUMENIS, INC. 510(k) NO: K091962(TRADITIONAL)
ATTN: MIKE AYMAMI PHONE NO : 408 764 3000 5302 BETSY ROSS RD, SE DECISION MADE: 30-SEP-09 SANTA CLARA CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARCUS PPEK CF INTERFERENCE SCREW PARCUS MEDICAL, LLC 510(k) NO: K091093(TRADITIONAL)
ATTN: BARTON BRACY PHONE NO : 920 746 2972 839 SOUTH NEENAH AVE. SE DECISION MADE: 30-SEP-09 STURGEON BAY WI 54235 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARCUS V-LOX PEEK CF SUTURE ANCHOR, MODELS: 10253, 10254, 10263, 10264 PARCUS MEDICAL, LLC 510(k) NO: K091094(TRADITIONAL)
ATTN: BARTON BRACY PHONE NO : 920 746 2972 839 SOUTH NEENAH AVE. SE DECISION MADE: 30-SEP-09 STURGEON BAY WI 54235 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868BF HEALTH & LIFE CO., LTD. 510(k) NO: K092161(TRADITIONAL)
ATTN: SARAH SU PHONE NO : 862 2 82271300 9F, NO.186, JIAN YI ROAD SE DECISION MADE: 30-SEP-09 CHUNG HO CITY, TAIPEI TW 235 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE EMBLA MEDICAL, INC. 510(k) NO: K092003(TRADITIONAL)
ATTN: ROBERT SCHUEPPERT PHONE NO : 303 962 1786 11001 W. 120TH AVE. SUITE 200 SE DECISION MADE: 30-SEP-09 BROOMFIELD CO 80021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL M00345100250 BOSTON SCIENTIFIC CORP. 510(k) NO: K092666(SPECIAL)
ATTN: JAMES LEATHLEY PHONE NO : 510 440 7836 47900 BAYSIDE PARKWAY SE DECISION MADE: 30-SEP-09 FREMONT CA 94538 6515 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 252 TOTAL WITH SUMMARIES 220 TOTAL WITH STATEMENTS 32
-
-