Medical Devices
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February 2010 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD February 2010 DEVICE: TISSUEBAG, MODELS: A10 211, A10 212, TBI 100, TBI1011, TBI1021 AGENCY FOR MEDICAL INNOVATIONS, IN510(k) NO: K092821(TRADITIONAL) ATTN: ANDREW BENDHEIM PHONE NO : 508 655 1200 20 MAIN ST., SUITE 205 SE DECISION MADE: 01-FEB-10 NATICK MA 01760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUANTA LITE APS/PT IGG AND IGM ELISA INOVA DIAGNOSTICS, INC. 510(k) NO: K090755(TRADITIONAL) ATTN: D. WALTER L BINDER PHONE NO : 858 586 9900 9900 OLD GROVE RD. SE DECISION MADE: 01-FEB-10 SAN DIEGO CA 92131 1638 510(k) STATEMENT DEVICE: EC50 MICRO+ SMOKERLYZER BEDFONT SCIENTIFIC LTD. 510(k) NO: K082315(TRADITIONAL) ATTN: GLEN HILLSLEY PHONE NO : 44 163 4673720 105 LAKER RD. SE DECISION MADE: 01-FEB-10 ROCHESTER, KENT UK ME1 3QX 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXPEN NEEDLE NOVO NORDISK INC. 510(k) NO: K090111(TRADITIONAL) ATTN: RICK SPRING PHONE NO : 609 987 5046 100 COLLEGE ROAD WEST SE DECISION MADE: 01-FEB-10 PRINCETON NJ 08540 7810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAP LOOP MEDSYS, S.A. 510(k) NO: K092897(TRADITIONAL) ATTN: WILLIAM F GREENROSE PHONE NO : 603 369 3550 220 RIVER RD. SE DECISION MADE: 01-FEB-10 CLAREMONT NH 03743 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLO COLOR ZIBO BOLIN GLOVES CO., LTD 510(k) NO: K093727(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 865 332 670878 RM. 1606 BLDG 1 JIAN XIANGYUAN BEISE DECISION MADE: 01-FEB-10 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE COLOPLAST MANUFACTURING US, LLC 510(k) NO: K093112(TRADITIONAL) ATTN: JANELL COLLEY PHONE NO : 612 287 4211 1601 WEST RIVER ROAD SE DECISION MADE: 01-FEB-10 MINNEAPOLIS MN 55411 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 1.0T 8-CHANNEL PANORAMA BREAST ARRAY COIL INVIVO CORPORATION 510(k) NO: K093284(TRADITIONAL) ATTN: ELIZABETH WHEELER PHONE NO : 352 336 0010 3545 SW 47TH AVE SE DECISION MADE: 01-FEB-10 GAINESVILLE FL 32608 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IU22 ULTRASOUND SYSTEM AND TRANSDUCERS PHILIPS ULTRASOUND, INC. 510(k) NO: K093563(TRADITIONAL) ATTN: NANCY BURKE PHONE NO : 425 487 7371 22100 BOTHELL EVERETT HWY. SE DECISION MADE: 01-FEB-10 BOTHELL WA 98041 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GEM FLOW COUPLER DEVICE AND SYSTEM SYNOVIS MICRO COMPANIES ALLIANCE, 510(k) NO: K093310(TRADITIONAL) ATTN: MELISSA J FORTH PHONE NO : 651 796 7332 2575 UNIVERSITY AVE. SE DECISION MADE: 01-FEB-10 SAINT PAUL MN 55114 1024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATLAS INTERVERTEBRAL BODY CAGE SPINAL EDGE, LLC 510(k) NO: K092774(TRADITIONAL) ATTN: CHRISTINA VACCA PHONE NO : 440 937 4068 33650 RESERVE WAY SE DECISION MADE: 02-FEB-10 AVON OH 44011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL EV3 INC 510(k) NO: K100063(SPECIAL) ATTN: LAURA HEATON PHONE NO : 949 837 3700 9775 TOLEDO WAY SE DECISION MADE: 02-FEB-10 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3H GENERAL MEDITECH, INC. 510(k) NO: K092970(TRADITIONAL) ATTN: LEE FU PHONE NO : 86 216 4684973 SUITE 5D, NO.19, LANE 999 ZHONGSHASE DECISION MADE: 02-FEB-10 SHANGHAI CH 200030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPLANTABLE CLIP GENICON 510(k) NO: K100090(SPECIAL) ATTN: GARY HABERLAND PHONE NO : 407 657 4851 6869 STAPOINT CT., SUITE 114 SE DECISION MADE: 02-FEB-10 WINTER PARK FL 32792 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVOLVE EPS ORTHOLOC WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K100146(SPECIAL) ATTN: KELSEY LEE PHONE NO : 901 290 5909 5677 AIRLINE RD. SE DECISION MADE: 02-FEB-10 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY FRACTURE AND FUSION PLATING SYSTEM DEPUY ORTHOPAEDICS, INC. 510(k) NO: K093474(TRADITIONAL) ATTN: SUZANA OTANO PHONE NO : 305 269 6386 700 ORTHOPAEDIC DR. SE DECISION MADE: 02-FEB-10 WARSAW IN 46581 0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-STERILE, POWDER-FREE, PINK LATEX EXAMINATION GLOVES WITH AND/OR WITHOUT STRAWBERRY SCENT AND WITH PROTEIN CONTENT OON CORP. RESOURCES 510(k) NO: K093496(TRADITIONAL) ATTN: JANNA P TUCKER PHONE NO : 775 342 2612 198 AVE. DE LA DEMERALD SE DECISION MADE: 03-FEB-10 SPARKS NV 89434 9550 510(k) STATEMENT DEVICE: AMPHETAMINES II ROCHE DIAGNOSTICS CORP. 510(k) NO: K083764(TRADITIONAL) ATTN: MICHELLE NEFF PHONE NO : 317 521 3742 9115 HAGUE RD. SE DECISION MADE: 03-FEB-10 INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VECTRA PLUS LASER SYSTEM AND ACCESSORIES XINTEC CORPORATION 510(k) NO: K082230(TRADITIONAL) ATTN: MARILYN M CHOU PHONE NO : 510 832 2130 1660 SOUTH LOOP RD. SE DECISION MADE: 03-FEB-10 ALAMEDA CA 94502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES MEDEFIL, INC. 510(k) NO: K092491(TRADITIONAL) ATTN: PRADEEP AGGARWAL PHONE NO : 630 682 4600 250 WINDY POINT DR. SE DECISION MADE: 03-FEB-10 GLENDALE HEIGHTS IL 60139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICRONJET 600 NANOPASS TECHNOLOGIES LTD. 510(k) NO: K092746(TRADITIONAL) ATTN: JONATHAN KAHAN PHONE NO : 202 637 5794 555 13TH ST. NW SE DECISION MADE: 03-FEB-10 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: R650 QDASM COLLIMATOR OMEGA MEDICAL IMAGING, INC. 510(k) NO: K093572(TRADITIONAL) ATTN: JAMES PRINCEHORN PHONE NO : 407 323 9400 675 HICKMAN CIRCLE SE DECISION MADE: 03-FEB-10 SANFORD FL 32771 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORIN METAFIX FEMORAL STEM CORIN USA 510(k) NO: K082525(TRADITIONAL) ATTN: ASHLEA BOWEN PHONE NO : 813 977 4469 10500 UNIVERSITY CENTER DRIVE SUITSE DECISION MADE: 04-FEB-10 TAMPA FL 33612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM OK BIOTECH CO., LTD. 510(k) NO: K090609(TRADITIONAL) ATTN: KE-MIN JEN PHONE NO : 886 3 5208829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 04-FEB-10 HSIN-CHU CITY TW 30067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPRESSOR FILTER, MODELS AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205, BACTERIA FILTER AG INDUSTRIES 510(k) NO: K091363(TRADITIONAL) ATTN: IAN GORDON PHONE NO : 512 327 9997 1705. CAPITAL OF TEXAS HWY SUITE 5SE DECISION MADE: 04-FEB-10 AUSTIN TX 78746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER CORDIS CORP., A JOHNSON & JOHNSON 510(k) NO: K091077(SPECIAL) ATTN: KAREN WILK PHONE NO : 908 541 4494 430 RTE 22 EAST SE DECISION MADE: 04-FEB-10 BRIDGEWATER NJ 08807 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA IMMCO DIAGNOSTICS, INC. 510(k) NO: K091522(TRADITIONAL) ATTN: KEVIN LAWSON PHONE NO : 716 691 0091 60 PINEVIEW DR. SE DECISION MADE: 04-FEB-10 BUFFALO NY 14228 2120 510(k) STATEMENT DEVICE: ESL SPINAL SYSTEM EBI, L.P. 510(k) NO: K092574(TRADITIONAL) ATTN: VIVIAN KELLY PHONE NO : 973 299 9300 100 INTERPACE PKWY. SE DECISION MADE: 04-FEB-10 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXUS INJECTION SITE, MODEL NIS-8 NEXUS MEDICAL, LLC 510(k) NO: K092527(SPECIAL) ATTN: HEATHER TURNER PHONE NO : 913 451 2234 11315 STRANG LINE ROAD SE DECISION MADE: 04-FEB-10 LENEXA KS 66215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINE360 ANTERIOR CERVICAL PLATE SYSTEM SPINE 360 510(k) NO: K092531(TRADITIONAL) ATTN: JOSHUA KAUFMANN PHONE NO : 512 772 3774 5000 PLAZA ON THE LAKE SUITE 305 SE DECISION MADE: 04-FEB-10 AUSTIN TX 78746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANTI-WRINKLE (AGING) LIGHT, MODEL AAL LED INTELLECTUAL PROPERTIES, LLC 510(k) NO: K092800(TRADITIONAL) ATTN: ROBERT T WAGNER PHONE NO : 865 982 5552 1131 ANTHEM VIEW LANE SE DECISION MADE: 04-FEB-10 KNOXVILLE TN 37922 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS PRONBP II STAT IMMUNOASSAY AND ELECSYS PRONBP II CALSET, MODELS 05390109-160, 04842472-190 ROCHE DIAGNOSTICS CORP. 510(k) NO: K092649(SPECIAL) ATTN: JANE E PHILLIPS PHONE NO : 317 521 3338 9115 HAGUE RD. SE DECISION MADE: 04-FEB-10 INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE, MODEL 228140, RAPIDLOC A2 MENISCAL REPAIR SYSTEM/12 DEGREE, MODEL 228141 DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K092836(TRADITIONAL) ATTN: ZHENG LIU PHONE NO : 508 977 3966 325 PARAMOUNT DR. SE DECISION MADE: 04-FEB-10 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY BLACKSTONE 510(k) NO: K100044(SPECIAL) ATTN: WHITNEY TORNING PHONE NO : 469 742 2500 1211 HAMBURG TURNPIKE, SUITE 300 SE DECISION MADE: 04-FEB-10 WAYNE NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT CLASSONE ORTHODONTICS, INC. 510(k) NO: K093059(TRADITIONAL) ATTN: JUDY RIBORDY PHONE NO : 806 776 0008 5064 50TH ST. SE DECISION MADE: 04-FEB-10 LUBBOCK TX 79414 510(k) STATEMENT DEVICE: PARI VIOS PARI RESPIRATORY EQUIPMENT, INC. 510(k) NO: K092918(TRADITIONAL) ATTN: MICHAEL JUDGE PHONE NO : 804 253 7274 2943 OAK LAKE BLVD. SE DECISION MADE: 04-FEB-10 MIDLOTHIAN VA 23112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM BOSTON SCIENTIFIC CORP. 510(k) NO: K093142(TRADITIONAL) ATTN: JAMES LEATHLEY PHONE NO : 510 440 7836 47900 BAYSIDE PARKWAY SE DECISION MADE: 04-FEB-10 FREMONT CA 94538 6515 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS ZIMMER, INC. 510(k) NO: K093846(SPECIAL) ATTN: BENJAMIN CURSON PHONE NO : 574 372 4119 P.O. BOX 708 SE DECISION MADE: 04-FEB-10 WARSAW IN 46581 0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 6F TRIPLE LUMEN POWERLINE CENTRAL VENOUS CATHETER, 5F DUAL LUMEN POWERLINE CENTRAL VENOUS CATHETER C.R. BARD, INC. 510(k) NO: K093927(SPECIAL) ATTN: SARABJYOT MANKOO PHONE NO : 801 522 5696 605 NORTH 5600 WEST SE DECISION MADE: 04-FEB-10 SALT LAKE CITY UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERTOS MEDICAL MILD DEVICE KIT X-STEN CORP. 510(k) NO: K093062(TRADITIONAL) ATTN: CRAIG COOMBS PHONE NO : 510 337 0140 1193 SHERMAN ST. SE DECISION MADE: 04-FEB-10 ALAMEDA CA 94501 1841 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANON, MODEL URS-50RF VIRTUAL IMAGING, INC. 510(k) NO: K093688(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 239 234 7135 8726 FERRARA CT SE DECISION MADE: 04-FEB-10 NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRONG DENTAL HANDPIECES SAESHIN PRECISION CO., LTD. 510(k) NO: K100192(TRADITIONAL) ATTN: Y.S. LEE PHONE NO : 82 53 5872345 #93-15, PAHO-DONG, DALSEO-GU SE DECISION MADE: 04-FEB-10 DAEGU KS 704-220 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: EXAPACS MEDINCOM TECHNOLOGY CORP 510(k) NO: K093444(TRADITIONAL) ATTN: ANDREW LEE PHONE NO : 886 289 132303 B1, NO.207-1, SEC.3, BEISIN RD SINSE DECISION MADE: 04-FEB-10 TAIPEI HSIEN TW 231 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM DEPUY SPINE, INC. 510(k) NO: K100070(SPECIAL) ATTN: CHRISTOPHER ROGERS PHONE NO : 508 828 3224 325 PARAMOUNT DR. SE DECISION MADE: 04-FEB-10 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMOSIL D-DIMER HS 500, CONTROLS INSTRUMENTATION LABORATORY CO. 510(k) NO: K090264(TRADITIONAL) ATTN: CAROL MARBLE PHONE NO : 781 861 4467 113 HARTWELL AVE. SE DECISION MADE: 05-FEB-10 LEXINGTON MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHO SELECT BONE PLATES AND SCREW SYSTEM ORTHO SELECT IMPLANT TECHNOLOGY GE510(k) NO: K091493(TRADITIONAL) ATTN: ANGELIKA SCHERP PHONE NO : 31 20 6125626 AMSTEL 320-1 SE DECISION MADE: 05-FEB-10 AMSTERDAM NL 1017AP 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACECIDE-C HIGH LEVEL DISINFECTANT AND STERILANT BEST SANITIZERS, INC. 510(k) NO: K091210(TRADITIONAL) ATTN: NORMAN MINER PHONE NO : 817 283 9100 1107-C SOUTH AIRPORT CIRCLE SE DECISION MADE: 05-FEB-10 EULESS TX 76040 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRUST DAM LINE ONE LABORATORIES, INC. 510(k) NO: K091769(ABBREVIATED) ATTN: ELI J CARTER PHONE NO : 919 544 4098 PO BOX 12139 SE DECISION MADE: 05-FEB-10 DURHAM NC 27709 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407 WELL-LIFE HEALTHCARE LIMITED 510(k) NO: K091757(TRADITIONAL) ATTN: JENNY HSIEH PHONE NO : 886 2 29282112 1FL, NO.16, LANE 454 JUNGJENG RD. SE DECISION MADE: 05-FEB-10 YUNGHE CITY, TAIPEI COUNTY TW 2510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPORT-ELEC BODY CONTROL SYSTEM "BS" SPORT-ELEC 510(k) NO: K092142(TRADITIONAL) ATTN: KIMBERLY JONES PHONE NO : 757 224 0177 141 RESEARCH DRIVE COMPLIANCE DEPTSE DECISION MADE: 05-FEB-10 HAMPTON VA 23666 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POCKET BVM MICROBVM SYSTEMS LTD 510(k) NO: K093081(TRADITIONAL) ATTN: ELI ORBACH PHONE NO : 972 299 32768 POB 6718 SE DECISION MADE: 05-FEB-10 EFRAT IS 90435 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACTIVE KNEE TOTAL KNEE REPLACEMENT SYSTEM ANOVA IMPLANT SOLUTIONS, LLC 510(k) NO: K093567(TRADITIONAL) ATTN: WALTER SPIRES PHONE NO : 615 457 3311 TWO MARYLAND FARMS SUITE 120 SE DECISION MADE: 05-FEB-10 BRENTWOOD TN 37027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM RADIOMETER MEDICAL APS 510(k) NO: K093154(TRADITIONAL) ATTN: JANA HELLMAN PHONE NO : 453 827 3827 AKANDEVEJ 21 SE DECISION MADE: 05-FEB-10 BRONSHOJ DA DK-2700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120 AGA MEDICAL CORP. 510(k) NO: K093476(TRADITIONAL) ATTN: AMANDA JOHNSON PHONE NO : 763 531 3058 5050 NATHAN LANE NORTH SE DECISION MADE: 05-FEB-10 PLYMOUTH MN 55442 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORA G72 BLODO GLUCOSE MONITORING SYSTEM/TD-4264 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4264 TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K093005(SPECIAL) ATTN: TELING HSU PHONE NO : 886 266 258188 6F, NO. 127, WUGONG 2ND RD WUGU TOSE DECISION MADE: 05-FEB-10 TAIPEI COUNTY TW 248 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENTELLUS MEDICAL BALLOON DEVICE ENTELLUS MEDICAL, INC. 510(k) NO: K093007(TRADITIONAL) ATTN: SEW-WAH TAY PHONE NO : 612 801 6782 18555 37TH AVENUE NORTH SE DECISION MADE: 05-FEB-10 PLYMOUTH MN 55446 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE IRIS INTERNATIONAL, INC. 510(k) NO: K093861(SPECIAL) ATTN: ELLEN JOHNSTON PHONE NO : 818 709 1244 9172 ETON AVE. SE DECISION MADE: 05-FEB-10 CHATSWORTH CA 91311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM BL HEALTHCARE, INC. 510(k) NO: K093379(TRADITIONAL) ATTN: MICHAEL MATHUR PHONE NO : 508 543 4150 33 COMMERCIAL ST., SUITE #3 SE DECISION MADE: 09-FEB-10 FOXBORO MA 02035 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300 JMS NORTH AMERICA CORP. 510(k) NO: K093637(TRADITIONAL) ATTN: E J SMITH PHONE NO : 410 451 0639 1468 HARWELL AVE SE DECISION MADE: 09-FEB-10 CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECTRO-LIGHT THERAPY HILL LABORATORIES CO. 510(k) NO: K090250(TRADITIONAL) ATTN: BRADY ALLER PHONE NO : 610 644 2867 3 BACTON HILL RD. SE DECISION MADE: 11-FEB-10 FRAZER PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC GIMMI GMBH 510(k) NO: K092421(ABBREVIATED) ATTN: KEN BLAKE PHONE NO : 651 298 0997 ONE SCANLAN PLAZA SE DECISION MADE: 12-FEB-10 SAINT PAUL MN 55107 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMFORTGEL NASAL MASK RESPIRONICS INC., SLEEP & HOME RES510(k) NO: K092835(TRADITIONAL) ATTN: ZITA A YURKO PHONE NO : 724 387 4120 1001 MURRY RIDGE LN. SE DECISION MADE: 12-FEB-10 MURRYSVILLE PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644 SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K093631(SPECIAL) ATTN: ANNA MARIE KATHLEEN ENNIS PHONE NO : 302 631 9352 500 GBC DRIVE M/S 514 PO BOX 6101 SE DECISION MADE: 12-FEB-10 NEWARK DE 19714 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MT9000 SERIES ELECTRO-STIMULATOR, MODELS MT9000, MT9002, MT9001, MT9004 AND MT9003 SHENZHEN DONGDIXIN TECHNOLOGY CO, 510(k) NO: K093138(TRADITIONAL) ATTN: ZHIGANG ZHAO PHONE NO : 86 755 27652471 XILIXIAOBAIMANG SE DECISION MADE: 12-FEB-10 SHENZHEN, GUANGDONG CH 518108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOSCOPE REPROCESSOR OER-PRO OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K093106(TRADITIONAL) ATTN: LAURA STORMS-TYLER PHONE NO : 484 896 5688 3500 CORPORATE PARKWAY SE DECISION MADE: 12-FEB-10 CENTER VALLEY PA 18034 0610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICE ADVANCED VASCULAR DYNAMICS 510(k) NO: K093192(TRADITIONAL) ATTN: HERBERT SEMLER PHONE NO : 503 525 6382 1910 NW 23RD PLACE SE DECISION MADE: 12-FEB-10 PORTLAND OR 97210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K093004(TRADITIONAL) ATTN: MICHAELA RIVKOWICH PHONE NO : 801 208 4196 1600 WEST MERIT PKWY. SE DECISION MADE: 12-FEB-10 SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX K2M, INC. 510(k) NO: K100061(SPECIAL) ATTN: RICHARD W WOODS PHONE NO : 703 777 3155 751 MILLER DR.,S.E., SUITE F1 SE DECISION MADE: 12-FEB-10 LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLIDER PTA BALLOON CATHETER TRIREME MEDICAL INC 510(k) NO: K094019(TRADITIONAL) ATTN: DENNIS SALZMANN PHONE NO : 925 931 1300 7060 KNOLL CENTER PARKWAY SUITE 30SE DECISION MADE: 12-FEB-10 PLEASANTON CA 94566 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MODIFIED STRAIGHT FIRE LASER FIBER BOSTON SCIENTIFIC CORP. 510(k) NO: K100078(TRADITIONAL) ATTN: JANET A MCGRATH PHONE NO : 508 683 4726 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 12-FEB-10 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MINI LAP RETRACTORS MINI LAP TECHNOLOGIES INC. 510(k) NO: K093449(SPECIAL) ATTN: JOSEPH AZARY PHONE NO : 203 922 0105 80 SHELTON TECHNOLOGY CENTER SE DECISION MADE: 12-FEB-10 SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WAYPOINT STEREOTACTIC SYSTEM FHC, INC. 510(k) NO: K092192(TRADITIONAL) ATTN: LEE D MARGOLIN PHONE NO : 207 666 5651 1201 MAIN ST SE DECISION MADE: 12-FEB-10 BOWDOIN ME 04287 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRAUMANN RC TEMPORARY ABUTMENTS STRAUMANN USA 510(k) NO: K093027(SPECIAL) ATTN: ELAINE ALAN PHONE NO : 800 448 8168 60 MINUTEMAN ROAD SE DECISION MADE: 12-FEB-10 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SELF ADHESIVE COMPOSITE LUTING CEMENT DMG USA, INC. 510(k) NO: K093338(ABBREVIATED) ATTN: PAMELA PAPINEAU PHONE NO : 978 772 3552 5 WHITCOMB AVE. SE DECISION MADE: 12-FEB-10 AYER MA 01432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMPLISEAL DISCUS DENTAL, LLC 510(k) NO: K093208(TRADITIONAL) ATTN: CLARK D VONAHSEN PHONE NO : 310 845 8216 8550 HIGUERA ST. SE DECISION MADE: 12-FEB-10 CULVER CITY CA 90232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO CAPSURE PS SYSTEM SPINE WAVE, INC. 510(k) NO: K100122(SPECIAL) ATTN: ROAIDA RIZKALLAH PHONE NO : 203 944 9494 THREE ENTERPRISE DR. SUITE 210 SE DECISION MADE: 12-FEB-10 SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F TOPCON CORP. 510(k) NO: K100207(TRADITIONAL) ATTN: TAKAO SUGAWARA PHONE NO : 81 3 35582566 75-1 HASUNUMA-CHO ITABASHI-KU SE DECISION MADE: 12-FEB-10 TOKYO JA 174-8580 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SR GLOVE, NU GLOVE, HIGHSTRESS MODEL 801, MODEL 802, MODEL 803 CENTRAL MEDICARE SDN BHD 510(k) NO: K093696(TRADITIONAL) ATTN: NICK WANG PHONE NO : 909 860 1908 1930 BREA CANYON ROAD #240, DIAMONSE DECISION MADE: 12-FEB-10 DIAMOND BAR CA 91765 510(k) STATEMENT DEVICE: SKELTEX ISV SKELTEX TECHNOLOGIES, INC. 510(k) NO: K091234(TRADITIONAL) ATTN: GEORGE PAPAGIANNIS PHONE NO : 514 236 1383 75 DE MORTAGNE BLVD. SE DECISION MADE: 16-FEB-10 BOUCHERVILLE, QUEBEC CA J4B 6Y4510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-STERILE DISPOSABLE VAGINAL SPECULUM KUNSHAN DEYI PLASTIC CO., LTD. 510(k) NO: K092870(TRADITIONAL) ATTN: CHARLIE MACK PHONE NO : 931 625 4938 77325 JOYCE WAY SE DECISION MADE: 16-FEB-10 ECHO OR 97826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLLAGEN SPONGE INNOCOLL PHARMACEUTICALS 510(k) NO: K092805(TRADITIONAL) ATTN: AARON WYSE PHONE NO : 353 906 666091 DUBLIN ROAD SE DECISION MADE: 16-FEB-10 ATHLONE, CO. WESTMEATH EI 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT TAPER, 2 PIECE PARODI GUIDEWIRE SYSTEM (LON BRIVANT, LTD. 510(k) NO: K093515(TRADITIONAL) ATTN: TOMAS FUREY PHONE NO : 353 913 85037 PARKMORE WEST BUSINESS PARK SE DECISION MADE: 16-FEB-10 GALWAY EI 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL158BT HEALTH & LIFE CO., LTD. 510(k) NO: K093824(SPECIAL) ATTN: SARAH SU PHONE NO : 886 282 271300 9F, NO.186, JIAN YI ROAD SE DECISION MADE: 16-FEB-10 CHUNG HO CITY, TAIPEI TW 235 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TROPAZONE CR MIDLOTHIAN LABORATORIES 510(k) NO: K093544(TRADITIONAL) ATTN: BRYCE HARVEY PHONE NO : 334 288 8661 760 INDUSTRIAL PARK BLVD. UNIT C SE DECISION MADE: 16-FEB-10 MONTGOMERY AL 36117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCOPE INTRODUCER MODEL 7400 N.M. BEALE CO. INC. 510(k) NO: K093329(TRADITIONAL) ATTN: PAMELA PAPINEAU PHONE NO : 978 772 3552 5 WHITCOMB AVENUE SE DECISION MADE: 16-FEB-10 AYER MA 01432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER SURGICAL DEVICES, A DIVISION OF TY510(k) NO: K100242(SPECIAL) ATTN: NISHITH DESAI PHONE NO : 203 492 6339 60 MIDDLETOWN AVE. SE DECISION MADE: 17-FEB-10 NORTH HAVEN CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS INTEGRA LIFESCIENCES CORP. 510(k) NO: K092227(TRADITIONAL) ATTN: JENNIFER BOSLEY PHONE NO : 717 789 6392 589 DAVIES DR. SE DECISION MADE: 17-FEB-10 YORK PA 17402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PDS PLATES ETHICON, INC. 510(k) NO: K092590(TRADITIONAL) ATTN: LESLIE YOUNG PHONE NO : 908 218 3275 U.S. ROUTE 22, WEST P.O. BOX 151 SE DECISION MADE: 17-FEB-10 SOMERVILLE NJ 08876 0151 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200 FLOWCARDIA, INC. 510(k) NO: K092175(TRADITIONAL) ATTN: DUSTIN MICHAELS PHONE NO : 408 617 0352 745 N. PASTORIA AVE. SE DECISION MADE: 17-FEB-10 SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50 PHILIPS MEDIZIN SYSTEME BOEBLINGEN510(k) NO: K092028(TRADITIONAL) ATTN: MICHAEL ASMALSKY PHONE NO : 497 031 4631277 HEWLETT-PACKARD STR. 2 SE DECISION MADE: 17-FEB-10 BOEBLINGEN GM D-71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REVERE STABILIZATION SYSTEM GLOBUS MEDICAL INC. 510(k) NO: K093294(SPECIAL) ATTN: KELLY J BAKER, PH.D PHONE NO : 610 415 9000 2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 17-FEB-10 AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM COLOPLAST A/S 510(k) NO: K100218(SPECIAL) ATTN: REBEKA STOLTMAN PHONE NO : 612 302 4997 1601 WEST RIVER ROAD NORTH SE DECISION MADE: 17-FEB-10 MINNEAPOLIS MN 55411 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XENIUM XPM 110, XENIUM XPM 130, MODELS M25649A, M25650A, XENIUM XPM 150, XENIUM XPM 170 BAXTER HEALTHCARE CORPORATION - RE510(k) NO: K093120(SPECIAL) ATTN: DIANE RENNPFERD PHONE NO : 847 473 6293 1620 WAUKEGAN ROAD BUILDING R SE DECISION MADE: 17-FEB-10 MCGAW PARK IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AFM ULTRA AG DRESSINGS MILLIKEN & CO. 510(k) NO: K093188(TRADITIONAL) ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508 643 0434 49 PLAIN STREET SE DECISION MADE: 17-FEB-10 NORTH ATTLEBORO MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM MEDTRONIC INC. 510(k) NO: K093650(TRADITIONAL) ATTN: JEFFREY KOLL PHONE NO : 763 514 9842 8200 CORAL SEA STREET SE DECISION MADE: 17-FEB-10 MOUNDS VIEW MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORE-FLO D/C BISCO, INC. 510(k) NO: K093470(TRADITIONAL) ATTN: MICHELLE SCHILTZ-TAING PHONE NO : 847 534 6000 1100 WEST IRVING PARK RD. SE DECISION MADE: 17-FEB-10 SCHAUMBURG IL 60193 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0 MATERIALISE N.V. 510(k) NO: K093533(TRADITIONAL) ATTN: KARL VOM BERGE PHONE NO : 32 163 96675 15 TECHNOLOGIELAAN SE DECISION MADE: 17-FEB-10 LEUVEN BE 3001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENSITITRE 18-24HR SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K093865(TRADITIONAL) ATTN: CINDY KNAPP PHONE NO : 216 351 8735 982 KEYNOTE CIRCLE SE DECISION MADE: 17-FEB-10 CLEVELAND OH 44131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560 SOMATEX MEDICAL TECHNOLOGIES GMBH 510(k) NO: K093064(TRADITIONAL) ATTN: SUSANNE RAAB PHONE NO : 617 547 0628 1480 CAMBRIDGE STREET SE DECISION MADE: 17-FEB-10 CAMBRIDGE MA 02139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESTEMP NE SPIDENT CO., LTD. 510(k) NO: K100290(TRADITIONAL) ATTN: I.S. HWANG PHONE NO : 823 281 94570 312, 151B-6L NAMDONGGONGDAN SE DECISION MADE: 17-FEB-10 INCHEON KS 405-821 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM ALPHATEC SPINE, INC. 510(k) NO: K100138(SPECIAL) ATTN: CHERYL ALLEN PHONE NO : 760 494 6770 5818 EL CAMINO REAL SE DECISION MADE: 17-FEB-10 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EDGELOCK ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K093900(TRADITIONAL) ATTN: DEREK LEWIS PHONE NO : 330 869 9562 1815 W. MARKET ST. SUITE 205 SE DECISION MADE: 17-FEB-10 AKRON OH 44313 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333 USGI MEDICAL 510(k) NO: K100251(SPECIAL) ATTN: MARY L MOONEY PHONE NO : 949 369 3890 1140 CALLE CORDILLERA SE DECISION MADE: 17-FEB-10 SAN CLEMENTE CA 92673 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RACEGEL SEPTODONT 510(k) NO: K093711(TRADITIONAL) ATTN: WAYNE MATELSKI, ESQ PHONE NO : 202 857 6340 1050 CONNECTICUT AVE., NW SE DECISION MADE: 17-FEB-10 WASHINGTON DC 20036 510(k) STATEMENT DEVICE: DIALOG WITH ADIMEA OPTION B. BRAUN AVITUM AG 510(k) NO: K083460(TRADITIONAL) ATTN: BONNIE KINCAID, RAC PHONE NO : 610 596 2970 901 MARCON BOULEVARD SE DECISION MADE: 18-FEB-10 ALLENTOWN PA 18109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM) REX MEDICAL 510(k) NO: K091029(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949 429 5825 55 NORTHERN BLVD. SUITE 200 SE DECISION MADE: 18-FEB-10 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HG II SHORT FIXTURE SYSTEM OSSTEM IMPLANT CO.,LTD 510(k) NO: K091678(TRADITIONAL) ATTN: PATRICK LIM PHONE NO : 267 759 7030 85 BEN FAIRLESS DR. SE DECISION MADE: 18-FEB-10 FAIRLESS HILLS PA 19030 510(k) STATEMENT DEVICE: LS-40 CO2 LASER SYSTEM MODEL LS-40 SANDSTONE MEDICAL TECHNOLOGIES, LL510(k) NO: K093793(SPECIAL) ATTN: MARK ROHRER PHONE NO : 205 290 8251 105 CITATION COURT SE DECISION MADE: 18-FEB-10 HOMEWOOD AL 35209 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARRIGEN ETEX CORP. 510(k) NO: K093447(SPECIAL) ATTN: CHRISTOPHER KLACZYK PHONE NO : 617 577 7270 38 SIDNEY ST., 3FLR THE CLARK BLDGSE DECISION MADE: 18-FEB-10 CAMBRIDGE MA 02139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODELS FORA V30 AND TD-4242 BLOOD GLUCOSE MONITORING SYSTEMS TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K093635(SPECIAL) ATTN: DEBRA LIANG PHONE NO : 886 2 66258188 6F, NO. 127, WUGONG 2ND RD WUGU TOSE DECISION MADE: 18-FEB-10 TAIPEI COUNTY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DURASPAN HEMODIALYSIS LONG-TERM CATHETER R4 VASCULAR, INC. 510(k) NO: K100169(SPECIAL) ATTN: LAURIE LEWANDOWSKI PHONE NO : 763 494 8400 7550 MERIDIAN CIR. N SE DECISION MADE: 18-FEB-10 MAPLE GROVE MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM BAXA CORP. 510(k) NO: K090917(TRADITIONAL) ATTN: JIM MORGAN PHONE NO : 303 469 5951 14445 GRASSLANDS DR. SE DECISION MADE: 19-FEB-10 ENGLEWOOD CO 80112 7062 510(k) STATEMENT DEVICE: PIONEER POSTERIOR CERVICO-THORACIC SYSTEM PIONEER SURGICAL TECHNOLOGY 510(k) NO: K092295(TRADITIONAL) ATTN: EMILY M DOWNS PHONE NO : 906 225 5602 375 RIVER PARK CIRCLE SE DECISION MADE: 19-FEB-10 MARQUETTE MI 49855 0627 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HAMMERLOCK BIOMEDICAL ENT., INC. 510(k) NO: K091951(TRADITIONAL) ATTN: JOE W SOWARD PHONE NO : 210 677 0354 14785 OMICRON DR., SUITE 205 SE DECISION MADE: 19-FEB-10 SAN ANTONIO TX 78245 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCELERATOR APS ABBOT LABORATORIES 510(k) NO: K093318(TRADITIONAL) ATTN: MARK LITTLEFIELD PHONE NO : 972 518 6062 1920 HURD DRIVE LC-2, MS 1-8 SE DECISION MADE: 19-FEB-10 IRVING TX 75038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTOUCH DIABETES SYMCARE PERSONALIZED HEALTH SOLUTI510(k) NO: K093789(TRADITIONAL) ATTN: RAE ANN DELAY PHONE NO : 484 686 4650 965 CHESTERBROOK BLVD SE DECISION MADE: 19-FEB-10 WAYNE PA 19087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUVASIVE HELIX REVOLUTION ACP SYSTEM NUVASIVE, INC. 510(k) NO: K093804(SPECIAL) ATTN: SHEILA BRUSCHI PHONE NO : 858 320 4515 7475 LUSK BLVD SE DECISION MADE: 19-FEB-10 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSCAR 3 ORTHOSONICS, LTD. 510(k) NO: K093805(TRADITIONAL) ATTN: MICHAEL J.R. YOUNG, PH.D. PHONE NO : 440 136 4652426 BREMRIDGE HOUSE SE DECISION MADE: 19-FEB-10 ASHBURTON, DEVON UK TQ137JX 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTIPLE NAME MODEL MULTIPLE GX CORPORATION SDN BHD (PLANT 1) 510(k) NO: K093759(TRADITIONAL) ATTN: CHO SOW FONG PHONE NO : 603 329 11600 LOT 6487-A, BATU 5 3/4 SEMENTA JALSE DECISION MADE: 19-FEB-10 KLANG, SELANGOR MY 510(k) STATEMENT DEVICE: ELI PC ELECTROCARDIOGRAPH MORTARA INSTRUMENT, INC. 510(k) NO: K093339(ABBREVIATED) ATTN: CHARLES MORREALE PHONE NO : 414 354 1600 7865 NORTH 86TH ST. SE DECISION MADE: 19-FEB-10 MILWAUKEE WI 53224 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS SMITH & NEPHEW, INC. 510(k) NO: K100197(SPECIAL) ATTN: GINO BROOKS PHONE NO : 901 399 6707 1450 BROOKS RD. SE DECISION MADE: 19-FEB-10 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONALIS SMITH ASSOCIATES 510(k) NO: K100204(TRADITIONAL) ATTN: E J SMITH PHONE NO : 888 729 9674 1676 VILLAGE GREEN, SUITE A SE DECISION MADE: 19-FEB-10 CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY BECTON DICKINSON & CO. 510(k) NO: K100209(SPECIAL) ATTN: PASQUALE AMATO PHONE NO : 201 847 4513 1 BECTON DRIVE MC237 SE DECISION MADE: 19-FEB-10 FRANKLIN LAKES NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORA G71A BLOOD GLUCOSE MONITORING SYSTEM, TD-4274 BLOOD GLUCOSE MONITORING SYSTEM TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K093712(SPECIAL) ATTN: NICKY PAN PHONE NO : 886 266 258188 6F, NO. 127, WUGONG 2ND RD WUGU TOSE DECISION MADE: 19-FEB-10 TAIPEI COUNTY TW 248 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COSP2 3M ESPE AG DENTAL PRODUCTS 510(k) NO: K093721(TRADITIONAL) ATTN: DESI W SOEGIARTO PHONE NO : 011 498 1527001169 ESPE PLATZ SE DECISION MADE: 19-FEB-10 SEEFELD, BAVARIA GM D-82229 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAPILLARYS NEONAT HB (PN 2006) SEBIA 510(k) NO: K091283(TRADITIONAL) ATTN: KAREN ANDERSON PHONE NO : 800 835 6497 1705 CORPORATE DRIVE SUITE 400 SE DECISION MADE: 22-FEB-10 NORCROSS GA 30093 510(k) STATEMENT DEVICE: NATUS NEUROWORKS, MODEL 104196 NATUS MEDICAL, INC. 510(k) NO: K090019(TRADITIONAL) ATTN: GOLDY SINGH PHONE NO : 905 829 5300 2568 BRISTOL CIRCLE SE DECISION MADE: 22-FEB-10 OAKVILLE, ONTARIO CA L6H 5S1 510(k) STATEMENT DEVICE: BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR ENDOCHOICE, INC. 510(k) NO: K092144(TRADITIONAL) ATTN: SHOSHANA FRIEDMAN PHONE NO : 704 430 8695 1914 J.N. PEASE PLACE SE DECISION MADE: 22-FEB-10 CHARLOTTE NC 28262 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POGO SCREW INSTRUMENTATION TRAY FXDEVICES 510(k) NO: K091806(TRADITIONAL) ATTN: RICH LIPSCHUTZ PHONE NO : 561 394 6501 ONE SOUTH OCEAN BLVD. SE DECISION MADE: 22-FEB-10 BOCA RATON FL 33432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDIGUARD NITRILE EXAMINATION GLOVE- BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) MEDLINE INDUSTRIES, INC. 510(k) NO: K093726(ABBREVIATED) ATTN: MATT CLAUSEN PHONE NO : 847 643 4785 ONE MEDLINE PL. SE DECISION MADE: 22-FEB-10 MUNDELEIN IL 60060 510(k) STATEMENT DEVICE: ALTERA NEBULIZER SYSTEM, MODEL 678G1002 PARI RESPIRATORY EQUIPMENT, INC. 510(k) NO: K100380(TRADITIONAL) ATTN: JAMES L MCINTIRE PHONE NO : 804 253 7274 2943 OAKLAKE BLVD. SE DECISION MADE: 22-FEB-10 MIDLOTHIAN VA 23112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BACT-TRAP HEPA MIDI PHARMA SYSTEMS AB 510(k) NO: K093426(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DR. SE DECISION MADE: 22-FEB-10 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003 ZUTRON MEDICAL LLC 510(k) NO: K093718(TRADITIONAL) ATTN: JOSEPH AZARY PHONE NO : 203 922 0105 80 SHELTON TECHNOLOGY CENTER SE DECISION MADE: 22-FEB-10 SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAS FLUALERT A&B, SAS INFLUENZA A TEST SA SCIENTIFIC, INC. 510(k) NO: K100227(SPECIAL) ATTN: ROBBI PERRY PHONE NO : 210 699 8800 4919 GOLDEN QUAIL SE DECISION MADE: 23-FEB-10 SAN ANTONIO TX 78240 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AESKULISA MPO, MODEL 30-7303US AESKU.DIAGNOSTICS 510(k) NO: K091860(TRADITIONAL) ATTN: SASCHA PFEIFFER PHONE NO : 49 673 496270 MIKROFORUM RING 2 SE DECISION MADE: 23-FEB-10 WENDELSHEIM, RHEINLAND GM D-552510(k) STATEMENT DEVICE: MEP-90 HAIR GROWTH STIMULATION SYSTEM MIDWEST R.F. LLC. 510(k) NO: K091496(TRADITIONAL) ATTN: HELMUT KEIDL PHONE NO : 262 367 8254 1050 WALNUT RIDGE DRIVE SE DECISION MADE: 23-FEB-10 HARTLAND WI 53029 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: P2 HIRISK FLUID RESISTANT FACEMASK TIDI PRODUCTS,LLC 510(k) NO: K092580(TRADITIONAL) ATTN: DION J BRANDT PHONE NO : 920 751 4386 570 ENTERPRISE DR. SE DECISION MADE: 23-FEB-10 NEENAH WI 54956 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SKIN BARRIER FILM LODESTAR PRODUCTS, INC. 510(k) NO: K092712(TRADITIONAL) ATTN: ERIC LUO PHONE NO : 214 243 8218 6833 SAINT LAWRENCE ST. SE DECISION MADE: 23-FEB-10 PLANO TX 75024 510(k) STATEMENT DEVICE: SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0 SMITH & NEPHEW, INC. 510(k) NO: K100107(SPECIAL) ATTN: REGINA HOLMES PHONE NO : 901 399 6538 1450 BROOKS RD. SE DECISION MADE: 23-FEB-10 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES (YELLOW, WHITE) SUPERMAX PLASTIC PRODUCTS CO., LTD510(k) NO: K093797(TRADITIONAL) ATTN: JIE LIU PHONE NO : 909 590 1611 3973 SCHAEFER AVENUE SE DECISION MADE: 23-FEB-10 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVE SUPERMAX PLASTIC PRODUCTS CO., LTD510(k) NO: K093798(TRADITIONAL) ATTN: JIE LIU PHONE NO : 909 590 1611 3973 SCHAEFER AVENUE SE DECISION MADE: 23-FEB-10 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNGO.PET&CT ONCOLOGY SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K093621(TRADITIONAL) ATTN: ALAINE MEDIO PHONE NO : 865 218 2703 810 INNOVATION DRIVE SE DECISION MADE: 23-FEB-10 KNOXVILLE TN 37932 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHROSTEER ABLATOR & COAGULATOR, MODELS: REF 1070 & 1080 ORTHODYNAMIX, LLC 510(k) NO: K093086(TRADITIONAL) ATTN: BRIAN S ZIMOVAN PHONE NO : 904 641 2599 10302 DEERWOOD PARK BLVD. SUITE 20SE DECISION MADE: 23-FEB-10 JACKSONVILLE FL 32256 4121 510(k) STATEMENT DEVICE: URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK URESIL, LLC 510(k) NO: K093653(TRADITIONAL) ATTN: LEV MELINYSHYN PHONE NO : 847 982 1154 5418 WEST TOUHY AVE. SE DECISION MADE: 23-FEB-10 SKOKIE IL 60077 510(k) STATEMENT DEVICE: CORVUS RADIATION THERAPY PLANNING SYSTEM BEST NOMOS 510(k) NO: K100092(SPECIAL) ATTN: CHI PALKO PHONE NO : 412 312 6700 ONE BEST DRIVE SE DECISION MADE: 23-FEB-10 PITTSBURGH PA 15202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED LATEX EXAMINATION GLOVES, NON-STERILE KHAI HOAN JOINT STOCK COMPANY 510(k) NO: K092681(TRADITIONAL) ATTN: PHAM N THANH PHONE NO : 84 065 0591220 CAU SAT HAMPLET, LAI HUNG COMMUNE,SE DECISION MADE: 23-FEB-10 BINH DUONG PROVINCE VM 510(k) STATEMENT DEVICE: CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 BINAX, INC. 510(k) NO: K091766(TRADITIONAL) ATTN: SUZANNE M VOGEL PHONE NO : 207 730 5733 10 SOUTHGATE RD. SE DECISION MADE: 24-FEB-10 SCARBOROUGH ME 04074 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUBREASE FEMALE LUBRICANT CURVES LIMITED 510(k) NO: K091298(TRADITIONAL) ATTN: NILUFER SMITH PHONE NO : 440 207 3716062 2 HIGH ROAD EASTCOTE SE DECISION MADE: 24-FEB-10 PINNER, MIDDLESEX UK HA5 2EW 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 12SL ECG ANALYSIS PROGRAM GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K092369(TRADITIONAL) ATTN: JOE LUCAS PHONE NO : 414 721 2593 9900 Innovation Drive SE DECISION MADE: 24-FEB-10 Wauwatosa WI 53226 0000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLAYTON INTRA-AURAL DEVICE (CID) ASCENTIA HEALTH INCORPORATED 510(k) NO: K091880(TRADITIONAL) ATTN: ROGER WIXTROM PHONE NO : 703 646 5820 8473 RIPPLED CREEK COURT SE DECISION MADE: 24-FEB-10 SPRINGFIELD VA 22153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BASESENS BLOOD GLUCOSE MONITORING SYSTEM HYGEIA, INC. 510(k) NO: K093475(TRADITIONAL) ATTN: ROBERT J BARD PHONE NO : 248 573 5040 P.O. BOX 506 SE DECISION MADE: 24-FEB-10 SOUTH LYON MI 48178 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEM EPS BIO TECHNOLOGY CORP. 510(k) NO: K092894(SPECIAL) ATTN: Y.C. LEI PHONE NO : 886 3 5752522 2 F,NO. 49-2, LANE 2, SEC. 2, GUANSE DECISION MADE: 24-FEB-10 HSINCHU CITY TW 30071 510(k) STATEMENT DEVICE: FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER FOOTPRINT MEDICAL 510(k) NO: K093026(TRADITIONAL) ATTN: CLYDE BAKER PHONE NO : 210 226 2600 1203 CAMDEN ST. SE DECISION MADE: 24-FEB-10 SAN ANTONIO TX 78215 510(k) STATEMENT DEVICE: TRAXCESS DOCKING WIRE MICROVENTION, INC. 510(k) NO: K093647(TRADITIONAL) ATTN: NAOMI GONG PHONE NO : 714 247 8055 1311 VALENCIA AVE SE DECISION MADE: 24-FEB-10 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DD BIO Z AND DD BIO Z - TRANSPA DENTAL DIREKT OF AMERIKA UG (HAFTU510(k) NO: K093748(ABBREVIATED) ATTN: GERHARD DE BOER PHONE NO : 49 522 5863190 PAPPELWEG 6 SE DECISION MADE: 24-FEB-10 SPENGE GM 32139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CL-DC20, CL-DC21 GOOD DOCTORS CO., LTD. 510(k) NO: K093751(TRADITIONAL) ATTN: KEVIN WALLS, RAC PHONE NO : 720 962 5412 5401 S. COTTONWOOD CT SE DECISION MADE: 24-FEB-10 GREENWOOD VILLAGE CO 80121 510(k) STATEMENT DEVICE: MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA MAKO SURGICAL CORP. 510(k) NO: K093425(TRADITIONAL) ATTN: WILLIAM TAPIA PHONE NO : 954 927 2044 2555 DAVIE RD. SE DECISION MADE: 24-FEB-10 FORT LAUDERDALE FL 33317 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GYRUS ACMI PK BUTTON ELECTRODE GYRUS ACMI, INC. 510(k) NO: K093181(TRADITIONAL) ATTN: GRAHAM A.L. BAILLIE PHONE NO : 508 804 2738 136 TURNPIKE RD. SE DECISION MADE: 24-FEB-10 SOUTHBOROUGH MA 01772 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERSAPULSE MODEL P20 LASER SYSTEM LUMENIS, INC. 510(k) NO: K100228(SPECIAL) ATTN: DOUG STANTE PHONE NO : 801 656 2620 3959 WEST 1820 SOUTH SE DECISION MADE: 24-FEB-10 SALT LAKE CITY UT 84104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERITITE UNIVERSAL CONTAINER SYSTEM AND MEDITRAY PRODUCTS CASE MEDICAL, INC. 510(k) NO: K090068(TRADITIONAL) ATTN: TANIA LUPU PHONE NO : 201 313 1999 65 RAILROAD AVE. SE DECISION MADE: 24-FEB-10 RIDGEFIELD NJ 07657 0402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST; UCP BIOSCIENCES, INC. 510(k) NO: K091612(TRADITIONAL) ATTN: NANCY CHEN PHONE NO : 408 392 0064 1445 KOLL CIRCLE, STE. 111 SE DECISION MADE: 24-FEB-10 SAN JOSE CA 95112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWERPUMP ARTHROSCOPY SYSTEM MEDICAL VISION AB 510(k) NO: K093409(TRADITIONAL) ATTN: CONSTANCE G BUNDY PHONE NO : 763 574 1976 435 RICE CREEK TERRACE SE DECISION MADE: 24-FEB-10 FRIDLEY MN 55432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXIMARC, MODEL CM-0.9-2-10-GG-L CORTEX MANUFACTURING, INC. 510(k) NO: K100267(TRADITIONAL) ATTN: ANDREW JONES PHONE NO : 425 334 2277 421 S. DAVIES RD. SE DECISION MADE: 24-FEB-10 LAKE STEVENS WA 98258 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ITG VASCULAR ACCESS SYSTEM, MODEL 300 ARSTASIS, INC. 510(k) NO: K091006(TRADITIONAL) ATTN: DOMINIQUE FILLOUX PHONE NO : 650 508 1549 1021 HOWARD AVE SUITE C SE DECISION MADE: 25-FEB-10 SAN CARLOS CA 94070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BINDER INTERVERTEBRAL BODY FUSION DEVICE BINDER BIOMEDICAL, INC 510(k) NO: K093015(TRADITIONAL) ATTN: LAWRENCE BINDER PHONE NO : 561 981 2682 2385 NW EXECUTIVE CENTER DRIVE SUISE DECISION MADE: 25-FEB-10 BOCA RATON FL 33431 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENSITE VELOCITY SYSTEM V1.3 ST. JUDE MEDICAL 510(k) NO: K093942(TRADITIONAL) ATTN: DONNA LUNAK PHONE NO : 651 756 2944 ONE ST. JUDE MEDICAL DRIVE SE DECISION MADE: 25-FEB-10 ST. PAUL MN 55117 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: VISION SCIENCES FLEXIBLE ENT SCOPE VISION-SCIENCES, INC. 510(k) NO: K100125(SPECIAL) ATTN: LILLIAN QUINTERO PHONE NO : 845 365 0600 40 RAMLAND RD. SOUTH SE DECISION MADE: 25-FEB-10 ORANGEBURG NY 10962 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS, LTD. 510(k) NO: K093741(TRADITIONAL) ATTN: CYNTHIA KNAPP PHONE NO : 216 351 8735 982 KEYNOTE CIRCLE SUITE 6 SE DECISION MADE: 25-FEB-10 CLEVELAND OH 44131 510(k) STATEMENT DEVICE: ADVOCATE REDI-COD DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223 TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K093592(SPECIAL) ATTN: DEBRA LIANG PHONE NO : 886 2 66258188 6F, NO. 127, WUGONG 2ND RD WUGU TOSE DECISION MADE: 25-FEB-10 TAIPEI COUNTY TW 248 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRAILRUNNER GUIDEWIRES LAKE REGION MFG., INC. 510(k) NO: K092965(TRADITIONAL) ATTN: KAREN MORTENSEN PHONE NO : 952 448 5111 340 LAKE HAZELTINE DR. SE DECISION MADE: 26-FEB-10 CHASKA MN 55318 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT CENDRES & METAUX SA 510(k) NO: K083876(TRADITIONAL) ATTN: PETER W FLEETWOOD PHONE NO : 41 32 3442211 RUE DE BOUJEAN 122 SE DECISION MADE: 26-FEB-10 BIEL/BIENNE SZ 2501 510(k) STATEMENT DEVICE: PYTON ARM MEDICAL DEVICES, INC. 510(k) NO: K092733(TRADITIONAL) ATTN: ANTHONY CALDERONI PHONE NO : 860 583 5165 190 DINO ROAD SE DECISION MADE: 26-FEB-10 BRISTOL CT 06010 7888 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASAHI ZENYTEEX GUIDING CATHETER ASAHI INTECC CO., LTD. 510(k) NO: K091188(TRADITIONAL) ATTN: YOSHI TERAI PHONE NO : 949 756 8252 2500 RED HILL SUITE 210 SE DECISION MADE: 26-FEB-10 SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPIROPALM COSMED S.R.L. 510(k) NO: K093174(TRADITIONAL) ATTN: ROBERT SCHIFF PHONE NO : 973 227 1830 1129 BLOOMFIELD AVENUE SUITE 202 SE DECISION MADE: 26-FEB-10 WEST CALDWELL NJ 07006 510(k) STATEMENT DEVICE: CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM, MODELS 60831, 60832, 60841 MEDTRONIC INC. 510(k) NO: K093203(SPECIAL) ATTN: MARY E DONLIN PHONE NO : 763 526 9172 710 MEDTRONIC PARKWAY NE SE DECISION MADE: 26-FEB-10 MINNEAPOLIS MN 55432 5604 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TELESENTRY, MODEL TS01 SCOTTCARE CORPORATION 510(k) NO: K092947(TRADITIONAL) ATTN: TIMOTHY J LEYVA PHONE NO : 216 362 0550 4791 WEST 150TH ST. SE DECISION MADE: 26-FEB-10 CLEVELAND OH 44135 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASEPT PERITONEAL DRAINAGE SYSTEM PFM MEDICAL, INC 510(k) NO: K093796(TRADITIONAL) ATTN: SALVADORE PALOMARES PHONE NO : 760 758 8749 2605 TEMPLE HEIGHTS DRIVE SUITE A SE DECISION MADE: 26-FEB-10 OCEANSIDE CA 92056 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE COOK, INC. 510(k) NO: K093209(TRADITIONAL) ATTN: SEAN WERNER PHONE NO : 812 339 2235 750 DANIELS WAY PO BX 489 SE DECISION MADE: 26-FEB-10 BLOOMINGTON IN 47402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASYCARE ONLINE RESMED LTD. 510(k) NO: K093684(TRADITIONAL) ATTN: DAVID D'CRUZ PHONE NO : 858 836 5984 9001 SPECTRUM CENTER BLVD. SE DECISION MADE: 26-FEB-10 BELLA VISTA CA 92123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) TANGSHAN JITENG PLASTIC PRODUCTS C510(k) NO: K100074(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 86 10 82387441 RM 1606 BLDG 1 JIANXIANG YUAN 209 SE DECISION MADE: 26-FEB-10 BEI SI HUAN ZHO, BEIJING CH 100510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE) TANGSHAN JITENG PLASTIC PRODUCTS C510(k) NO: K100075(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 86 10 82387441 RM 1606 BLDG 1 JIANXIANG YUAN 209 SE DECISION MADE: 26-FEB-10 BEI SI HUAN ZHO, BEIJING CH 100510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020 CAREFUSION 510(k) NO: K093463(TRADITIONAL) ATTN: SHARON NICHOLS PHONE NO : 847 578 6610 1500 WAUKEGAN ROAD SE DECISION MADE: 26-FEB-10 MCGAW PARK IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER TERUMO CORP. 510(k) NO: K100282(SPECIAL) ATTN: CHRISTINA FLANAGAN PHONE NO : 410 392 7231 950 ELKTON BOULEVARD SE DECISION MADE: 26-FEB-10 ELKTON MD 21921 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 183 TOTAL WITH SUMMARIES 159 TOTAL WITH STATEMENTS 24
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