The Food & Drug Administration released the pre-market approvals it granted during August:
August 2010 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD August 2010 DEVICE: LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV BIO-RAD LABORATORIES 510(k) NO: K091303(TRADITIONAL)
ATTN: SUZANNE S PARSONS PHONE NO : 949 598 1467 9500 JERONIMO RD. SE DECISION MADE: 02-AUG-10 IRVINE CA 92618 2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U HOBBS MEDICAL, INC. 510(k) NO: K093079(TRADITIONAL)
ATTN: EMILY MADSEN PHONE NO : 860 684 5875 8 SPRING ST. SE DECISION MADE: 02-AUG-10 STAFFORD SPRINGS CT 06076 510(k) STATEMENT DEVICE: STA-HYBRID HEP CALIBRATOR DIAGNOSTICA STAGO, INC. 510(k) NO: K092937(TRADITIONAL)
ATTN: UMBERTO V PARROTTA PHONE NO : 973 631 1200 5 CENTURY DR. SE DECISION MADE: 02-AUG-10 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER ONSET MEDICAL CORPORATION 510(k) NO: K100819(SPECIAL)
ATTN: JOSEPH BISHOP PHONE NO : 949 716 1100 13900 ALTON PARKWAY, SUITE 120 SE DECISION MADE: 02-AUG-10 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012 ENCORE MEDICAL, L.P. 510(k) NO: K100741(SPECIAL)
ATTN: TEFFANY HUTTO PHONE NO : 512 834 6255 9800 METRIC BLVD. SE DECISION MADE: 02-AUG-10 AUSTIN TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RANGE SPINAL SYSTEM K2M, INC. 510(k) NO: K100851(TRADITIONAL)
ATTN: NANCY GIEZEN PHONE NO : 703 777 3155 751 MILLER DR.,S.E., SUITE F1 SE DECISION MADE: 02-AUG-10 LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASCENSION TOTAL PLATE SYSTEM ASCENSION ORTHOPEDICS, INC. 510(k) NO: K100502(TRADITIONAL) ATTN: DEBBIE STEARNS PHONE NO : 512 836 5001 8700 CAMERON RD., STE. 100 SE DECISION MADE: 02-AUG-10 AUSTIN TX 78754 3832 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SLENDERTONE FLEX MAX, MODEL 517 US BIO-MEDICAL RESEARCH, LTD. 510(k) NO: K100556(TRADITIONAL)
ATTN: ANNE-MARIE KEENAN PHONE NO : 353 917 74300 BMR HOUSE PARKMORE BUSINESS PARK, SE DECISION MADE: 02-AUG-10 GALWAY EI 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138 SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K100200(TRADITIONAL)
ATTN: KIRA GORDON PHONE NO : 914 524 2996 511 BENEDICT AVENUE SE DECISION MADE: 02-AUG-10 TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEODENT IMPLANT SYSTEM JJGC INDUSTRIA E COMERCIO DE MATER510(k) NO: K101207(TRADITIONAL)
ATTN: KEVIN A THOMAS PHONE NO : 858 792 1235 11234 EL CAMINO REAL SUITE 200 SE DECISION MADE: 02-AUG-10 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES MILTEX, INC. 510(k) NO: K101653(TRADITIONAL)
ATTN: JENNIFER BOSLEY, MBA, RAC PHONE NO : 717 781 6392 589 DAVIES DRIVE SE DECISION MADE: 02-AUG-10 YORK PA 17402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRAVSCULAR ADMINISTRATION SET TERUMO EUROPE N.V. 510(k) NO: K100946(SPECIAL)
ATTN: M.J. AERTS PHONE NO : 321 638 1211 INTERLEUVENLAAN 40 SE DECISION MADE: 02-AUG-10 LEUVEN BE 3001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTETRAK LOGIC COMBINATION TIBIAL TRAY EXACTECH, INC. 510(k) NO: K101981(SPECIAL) ATTN: PATRICK HUGHES PHONE NO : 352 377 1140 2320 N.W. 66TH CT. SE DECISION MADE: 02-AUG-10 GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXACTECH EQUINOXE, PLATFORM FRACTURE STEM EXACTECH, INC. 510(k) NO: K101909(SPECIAL)
ATTN: GRAHAM L CUTHBERT PHONE NO : 352 377 1140 2320 N.W. 66TH CT. SE DECISION MADE: 02-AUG-10 GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM STERIS CORPORATION 510(k) NO: K101409(SPECIAL)
ATTN: ROBERT SULLIVAN PHONE NO : 440 354 2600 5960 HEISLEY RD. SE DECISION MADE: 02-AUG-10 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALIGN RADIAL HEAD SYSTEM SKELETAL DYNAMICS, LLC 510(k) NO: K092721(TRADITIONAL)
ATTN: JOSEPH AZARY PHONE NO : 203 922 0105 80 SHELDON TECHNOLOGY CENTER SE DECISION MADE: 03-AUG-10 SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 1-M GRADUATED COMPRESSION ANTI-EMBOLISM STOCKING, MODEL SS-811, SS-508, SS-613 I-MING SANITARY MATERIALS CO., LTD510(k) NO: K092892(TRADITIONAL)
ATTN: SARA HOU PHONE NO : 886 488 19638 101-10 DU TU LN., ER HSI RD., PEISSE DECISION MADE: 03-AUG-10 HSIHU, CHANG HUA TW 510(k) STATEMENT DEVICE: NEOMED ENTERAL ONLY EXTENSION SET NEOMED, INC. 510(k) NO: K100288(TRADITIONAL)
ATTN: PENNY NORTHCUTT PHONE NO : 678 428 6978 717 LAKEGLEN DR. SE DECISION MADE: 03-AUG-10 SUWANEE GA 30024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM SYNTHES (USA) 510(k) NO: K100776(TRADITIONAL)
ATTN: KARL J NITTINGER PHONE NO : 610 719 6940 1301 GOSHEN PKWY. SE DECISION MADE: 03-AUG-10 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLONOSCOPE/SIGMOIDOSCOPE SHEATHES SHEATHING TECHNOLOGIES, INC. 510(k) NO: K100966(TRADITIONAL)
ATTN: JENNIFER DOWNING PHONE NO : 408 782 2720 18431 TECHNOLOGY DR. SE DECISION MADE: 03-AUG-10 MORGAN HILL CA 95037 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB AIR TECHNIQUES, INC. 510(k) NO: K101289(TRADITIONAL)
ATTN: PABLO MARTINEZ PHONE NO : 516 214 5541 1295 WALT WHITMAN RD. SE DECISION MADE: 03-AUG-10 MELVILLE NY 11747 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MODEL: 21-3253-24, 21-3258-24, 21-3262-24, SMITHS MEDICAL MD, INC. 510(k) NO: K101180(TRADITIONAL)
ATTN: SAINT PAUL PHONE NO : 615 628 7018 1265 GREY FOX RD. SE DECISION MADE: 03-AUG-10 ST. PAUL MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL THERMOMETER, MODELS BT-A11CN, BT-A21CN, BT-A41CN FUDAKANG INDUSTRIES CO., LTD 510(k) NO: K101387(TRADITIONAL)
ATTN: STEPHEN LING PHONE NO : 867 558 3089699 ROOM 2706 , BLOCK A ZHONGFANG JIN SE DECISION MADE: 03-AUG-10 SHENZHEN, GUANGDON CH 518034 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ICAD VERALOOK CTC CAD SOFTWARE ICAD, INC. 510(k) NO: K091529(TRADITIONAL)
ATTN: JOHN A DELUCIA PHONE NO : 937 431 7945 98 SPIT BROOK ROAD SUITE 100 SE DECISION MADE: 04-AUG-10 NASHUA NH 03062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOMAP 3D 1.1 MODULE STRYKER CORP. 510(k) NO: K093206(TRADITIONAL)
ATTN: LILIAN ECKERT PHONE NO : 497 614 512117 BOTZINGER STRABE 41 SE DECISION MADE: 04-AUG-10 FREIBURG GM D-79111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUSIMETRY CHECK MATH RESOLUTIONS, LLC. 510(k) NO: K101503(TRADITIONAL)
ATTN: WENDEL D RENNER PHONE NO : 410 997 9578 5975 GALES LN. SE DECISION MADE: 04-AUG-10 COLUMBIA MD 21045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORRIDOR4DM V2010 MODEL: V2010 INVIA 510(k) NO: K101279(TRADITIONAL)
ATTN: DAVID ROTHKOPF PHONE NO : 508 231 8842 200 HOMER AVENUE SE DECISION MADE: 04-AUG-10 ASHLAND MA 01721 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCANDIA-45 GAMMA CAMERA SYSTEM SCANDIA CORPORATION 510(k) NO: K101391(TRADITIONAL)
ATTN: DAVID ASKEW PHONE NO : 515 334 5131 10200 DENNIS DRIVE SUITE 5 SE DECISION MADE: 04-AUG-10 URBANDALE IA 50322 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K COMPUTERIZED SCREENING, INC. 510(k) NO: K101198(TRADITIONAL)
ATTN: SAM KUMAR PHONE NO : 775 359 1191 9550 GATEWAY DRIVE SE DECISION MADE: 04-AUG-10 RENO NV 89521 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CONTRALCO CONTRALCO 510(k) NO: K100879(TRADITIONAL)
ATTN: CAMILLE D THORNTON PHONE NO : 757 224 0177 144 RESEARCH DRIVE SE DECISION MADE: 04-AUG-10 HAMPTON VA 23666 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REEFLEX PTA CATHETER CLEARSTREAM TECHNOLOGIES, LTD. 510(k) NO: K101361(TRADITIONAL)
ATTN: FIONA N MHULLAIN PHONE NO : 353 53 9237111 MOYNE UPPER SE DECISION MADE: 04-AUG-10 ENNISCORTHY, COUNTY WEXFORD EI 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEOTRACT ANCHOR SYSTEM MODEL TAS400 NEOTRACT, INC. 510(k) NO: K102028(SPECIAL)
ATTN: KEVIN F MACDONALD PHONE NO : 415 609 9875 4473 WILLOW ROAD SUITE 100 SE DECISION MADE: 04-AUG-10 PLEASANTON CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES MODEL 6021791-PRO 4000 SERIES, 6022790-IRT 4000 SE KAZ USA, INC (A SUBSIDIARYOF KAZ I510(k) NO: K101747(SPECIAL)
ATTN: RAJ KASBEKAR PHONE NO : 508 490 7280 250 TURNPIKE ROAD SE DECISION MADE: 04-AUG-10 SOUTHBOROUGH MA 01772 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTE510(k) NO: K093868(TRADITIONAL)
ATTN: AL LIPPINCOTT PHONE NO : 952 492 5858 3150 E. 200TH ST. SE DECISION MADE: 05-AUG-10 PRIOR LAKE MN 55372 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTI-PURPOSE HEALTH DEVICE UPC MEDICAL SUPPLIES, INC. DBA UNI510(k) NO: K093322(TRADITIONAL) ATTN: DANIEL HUE PHONE NO : 626 285 1600 317 S. SAN MARINO AVE. SE DECISION MADE: 05-AUG-10 SAN GABRIEL CA 91776 510(k) STATEMENT DEVICE: WENZEL SPINE VARILIFT INTERBODY FUSION SYSTEM WENZEL SPINE 510(k) NO: K100820(TRADITIONAL)
ATTN: SOURABH MISHRA PHONE NO : 512 501 4017 2720 BEE CAVE ROAD SE DECISION MADE: 05-AUG-10 AUSTIN TX 78746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO SYNTHES MATRIX SYSTEM SYNTHES SPINE 510(k) NO: K100952(SPECIAL)
ATTN: JASON LIPMAN PHONE NO : 610 719 5629 1302 WRIGHTS LANE EAST SE DECISION MADE: 05-AUG-10 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS ENDOCHOICE, INC. 510(k) NO: K101298(TRADITIONAL)
ATTN: THERON GOBER PHONE NO : 678 534 6021 11800 WILLIS RD SUITE 100 SE DECISION MADE: 05-AUG-10 ALPHARETTA GA 30009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331 SALUMEDICA, L.L.C. 510(k) NO: K100382(TRADITIONAL)
ATTN: BOB BRADEN PHONE NO : 404 876 6643 931 E PONCE DE LEON AVE SE DECISION MADE: 05-AUG-10 ATLANTA GA 30306 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BUSSE EPIDURAL CATHETER KIT BUSSE HOSPITAL DISPOSABLES 510(k) NO: K093920(TRADITIONAL)
ATTN: MUHAMAD ANSARI PHONE NO : 631 435 4711 75 ARKAY DRIVE SE DECISION MADE: 06-AUG-10 HAUPPAUGE NY 11788 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABL90 FLEX SERIES RADIOMETER MEDICAL APS 510(k) NO: K092686(TRADITIONAL)
ATTN: LONE RONNEMOES PEDERSEN PHONE NO : 453 827 3335 AKANDEVEJ 21 SE DECISION MADE: 06-AUG-10 BRONSHOJ DA DK-2700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310 DRAEGER MEDICAL AG & CO. KG 510(k) NO: K092029(TRADITIONAL)
ATTN: JOYCE KILROY PHONE NO : 215 660 2626 3135 QUARRY ROAD SE DECISION MADE: 06-AUG-10 TELFORD PA 18969 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY SMITH & NEPHEW, INC. 510(k) NO: K102001(SPECIAL)
ATTN: LAURA REYNOLDS PHONE NO : 727 399 7702 970 LAKE CARILLON DR. SUITE 110 SE DECISION MADE: 06-AUG-10 ST. PETERSBURG FL 33716 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MISSION SALIVA ALCOHOL TEST STRIP ACON LABORATORIES, INC. 510(k) NO: K093879(TRADITIONAL)
ATTN: RICHARD LENART PHONE NO : 858 875 8019 10125 MESA RIM RD. SE DECISION MADE: 06-AUG-10 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0 EARLYSENSE LTD. 510(k) NO: K100376(TRADITIONAL) ATTN: DALIA ARGAMAN PHONE NO : 972 375 22330 12 TZVI STREET SE DECISION MADE: 06-AUG-10 RAMAT GAN IS 52504 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500 AVINGER, INC. 510(k) NO: K101647(SPECIAL)
ATTN: HIMANSHU PATEL PHONE NO : 650 216 7400 400 CHESAPEAKE DRIVE SE DECISION MADE: 06-AUG-10 REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEILER COLPOSCOPE, MODELS 935, 955 AND 985 SEILER PRECISION MICROSCOPES 510(k) NO: K101141(TRADITIONAL)
ATTN: DAN MEYER PHONE NO : 314 218 3344 3433 TREE CT INDUSTRIAL BLVD SE DECISION MADE: 06-AUG-10 ST. LOUIS MO 63122 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEADWAY 17 ADVANCED MICROCATHETER MICROVENTION, INC. 510(k) NO: K101542(TRADITIONAL)
ATTN: NAOMI GONG PHONE NO : 714 247 8055 1311 VALENCIA AVE SE DECISION MADE: 06-AUG-10 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: STINGRAY ORIENTING BALLOON CATHETER BRIDGEPOINT MEDICAL 510(k) NO: K101591(SPECIAL)
ATTN: JILL MUNSINGER PHONE NO : 763 225 8500 2800 CAMPUS DR STE 50 SE DECISION MADE: 06-AUG-10 PLYMOUTH MN 55441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LANX SPINAL FIXATION SYSTEM LANX, INC. 510(k) NO: K100935(SPECIAL)
ATTN: ANDREW LAMBORNE PHONE NO : 303 443 7500 390 INTERLOCKEN CRESCENT SUITE 890SE DECISION MADE: 06-AUG-10 BROOMFIELD CO 80021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235 ION BEAM APPLICATIONS S.A. 510(k) NO: K101508(SPECIAL)
ATTN: JOHN B REISS PHONE NO : 215 972 7124 1500 MARKET STREET CENTRE SQUARE WSE DECISION MADE: 06-AUG-10 PHILADELPHIA PA 19102 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S AVINGER, INC. 510(k) NO: K102022(SPECIAL)
ATTN: HIMANSHU PATEL PHONE NO : 650 216 7400 400 CHESAPEAKE DRIVE SE DECISION MADE: 06-AUG-10 REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASOPRESS SUPREME MINI MODEL VP500DM COMPRESSION THERAPY CONCEPTS, INC.510(k) NO: K101915(SPECIAL)
ATTN: LEONARD NASS PHONE NO : 732 544 0800 35 JAMES WAY SE DECISION MADE: 06-AUG-10 EATONTOWN NJ 07724 510(k) STATEMENT DEVICE: ENDOSCOPIC CLIP SYSTEM AESCULAP, INC. 510(k) NO: K102081(SPECIAL)
ATTN: DENISE ADAMS PHONE NO : 610 984 9076 3773 CORPORATE PARKWAY SE DECISION MADE: 06-AUG-10 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TISSU TRANS FILTRON SYRINGE FILL SHIPPERT MEDICAL TECHNOLOGIES CORP510(k) NO: K102117(SPECIAL)
ATTN: SARAH LAKE SHIPPERT PHONE NO : 303 754 0044 6248 SOUTH TROY CIRCLE UNIT A SE DECISION MADE: 06-AUG-10 CENTENNIAL CO 80111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OCCLUSION BALLOON CATHETER MODEL OBC COOK, INC. 510(k) NO: K101877(SPECIAL)
ATTN: LISA WEBB PHONE NO : 812 339 2235 750 DANIELS WAY PO BX 489 SE DECISION MADE: 06-AUG-10 BLOOMINGTON IN 47402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE BETTER CARE PLASTIC TECHNOLOGY CP.510(k) NO: K101595(TRADITIONAL)
ATTN: JIE LIU PHONE NO : 909 590 1611 3973 SCHAEFER AVE SE DECISION MADE: 06-AUG-10 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. 510(k) NO: K102065(TRADITIONAL)
ATTN: PARK KYEONG-MI PHONE NO : 822 219 41373 1003 DAECHI-DONG GANGNAM-GU SE DECISION MADE: 06-AUG-10 SEOUL KS 135-280 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I MICROSULIS MEDICAL LIMITED 510(k) NO: K094021(TRADITIONAL)
ATTN: DENISE REXHAUS PHONE NO : 011 442 392240011 UNITS 1 & 2 FALCON COURT PARKLANDSSE DECISION MADE: 06-AUG-10 DENMEAD HAMPSHIRE UK PO7 6XP 510(k) STATEMENT DEVICE: MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R MEDTRONIC INC. 510(k) NO: K101212(TRADITIONAL)
ATTN: BECKY HANNACK PHONE NO : 763 514 9840 8200 CORAL SEA STREET NE SE DECISION MADE: 07-AUG-10 MOUNDS VIEW MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL XMARU 1717 E-WOO TECHNOLOGY 510(k) NO: K091090(TRADITIONAL)
ATTN: VINCENT LEE PHONE NO : 281 598 8110 256 NORTH SAM HOUSTON PKWY E. SUITSE DECISION MADE: 09-AUG-10 HOUSTON TX 77060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERSITOMIC ACL FLEXIBLE REAMER SYSTEM STERILIZATION TRAY T.A.G. MEDICAL PRODUCTS 510(k) NO: K100887(TRADITIONAL) ATTN: GEORGE J HATTUB PHONE NO : 508 479 6116 291 HILLSIDE AVENUE SE DECISION MADE: 09-AUG-10 SOMERSET MA 02726 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430 MEDICEL AG 510(k) NO: K101134(TRADITIONAL)
ATTN: JOHN COGGAN PHONE NO : 626 303 7902 1911 WALKER AVE SE DECISION MADE: 09-AUG-10 MONROVIA CA 91016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BENZ-G 4X (HIOXIFILCON D) MULTIFOCAL LATHED LENS BENZ RESEARCH AND DEVELOPMENT CORP510(k) NO: K101122(TRADITIONAL)
ATTN: GIOVANNY ESPINOSA PHONE NO : 941 758 8256 6447 PARKLAND DR. SE DECISION MADE: 09-AUG-10 SARASOTA FL 34243 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW CAPINTEC, INC. 510(k) NO: K101452(SPECIAL)
ATTN: MARY ANNE DELL PHONE NO : 412 963 1988 620 ALPHA DR. SE DECISION MADE: 09-AUG-10 PITTSBURGH PA 15238 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASHE WOUND THERAPY SYSTEM MODEL: 9000-0014 PURICORE INC. 510(k) NO: K100918(TRADITIONAL)
ATTN: DENNIS MAHONEY PHONE NO : 484 321 2724 508 LAPP RD. SE DECISION MADE: 09-AUG-10 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WELLMIEN SURGICAL MASK WELLMIEN (SUZHOU) IMPORT AND EXPOR510(k) NO: K101000(ABBREVIATED)
ATTN: CHENGYU SHEN PHONE NO : 608 217 9358 5 CAREY STREET SE DECISION MADE: 09-AUG-10 PENNINGTON NJ 08534 510(k) STATEMENT DEVICE: ALLURA XPER OR TABLE SERIES PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K102005(TRADITIONAL)
ATTN: LYNN HARMER PHONE NO : 425 487 7312 22100 BOTHELL EVERETT HWY SE DECISION MADE: 09-AUG-10 BOTHELL WA 98041 3003 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20 BAYLIS MEDICAL CO., INC. 510(k) NO: K101372(SPECIAL)
ATTN: MEGHAL KHAKHAR PHONE NO : 905 602 4875 2645 MATHESON BLVD. E SE DECISION MADE: 10-AUG-10 MISSISSAUGA, ONTARIO CA L4W 5S4510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVOLUTION UNICONDYLAR KNEE SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K100973(TRADITIONAL)
ATTN: DANIELLE MUELLER PHONE NO : 901 290 5904 5677 AIRLINE RD. SE DECISION MADE: 10-AUG-10 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM PIONEER SURGICAL TECHNOLOGY 510(k) NO: K093771(TRADITIONAL)
ATTN: EMILY DOWNS PHONE NO : 906 225 5602 375 RIVER PARK CIRCLE SE DECISION MADE: 10-AUG-10 MARQUETTE MI 49855 0627 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARP POV SPORT ARP MANUFACTURING, INC 510(k) NO: K093999(TRADITIONAL)
ATTN: LEWIS WARD PHONE NO : 303 530 3279 4655 KIRKWOOD COURT SE DECISION MADE: 10-AUG-10 BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AQUANOVA AG SUPER ABSORBANT DRESSING, AQUANOVA AG ANTIMICROBIAL DRESSING MEDTRADE PRODUCTS LIMITED 510(k) NO: K100693(TRADITIONAL)
ATTN: JONATHAN D RANFIELD PHONE NO : 441 270 500019 ELECTRA HOUSE CREW BUSINESS PARK SE DECISION MADE: 10-AUG-10 CREWE, CHESHIRE UK CWI 6GL 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATLAS SPINE PIVOTING SYSTEM ATLAS SPINE INC. 510(k) NO: K100743(TRADITIONAL)
ATTN: JEANNETTE G DAILEY PHONE NO : 561 354 4319 1555 JUPITER PARK DR., STE. 4 SE DECISION MADE: 10-AUG-10 JUPITER FL 33458 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNGO. PLAZA VA20A SIEMENS AG, MEDICAL SOLUTIONS 510(k) NO: K101666(TRADITIONAL)
ATTN: SABINE SCHROEDEL PHONE NO : 491 318 48285 HENKESTRASSE 127 SE DECISION MADE: 10-AUG-10 ERLANGEN GM 91052 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: LIFELINES PHOTIC STIMULATOR LIFELINES LTD. 510(k) NO: K101691(TRADITIONAL)
ATTN: E. J AMITH PHONE NO : 888 729 9674 1468 HARWELL AVENUE SE DECISION MADE: 10-AUG-10 CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARIAN UNIQUE SINGLE ENERGY LINEAR ACCELERATOR VARIAN MEDICAL SYSTEMS, ONCOLOGY S510(k) NO: K101751(TRADITIONAL)
ATTN: VY TRAN PHONE NO : 650 424 5731 3100 HANSEN WAY SE DECISION MADE: 10-AUG-10 PALO ALTO CA 94304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONOTRAX SERIES ULTRASONIC POCKET DOPPLER EDAN INSTRUMENTS, INC. 510(k) NO: K101960(SPECIAL)
ATTN: YUE QIUHONG PHONE NO : 867 552 6899197 3/F-B, NANSHAN MEDICAL EQUIPMENT PSE DECISION MADE: 10-AUG-10 SHENZHEN CH 518067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682 DFINE, INC. 510(k) NO: K091310(TRADITIONAL)
ATTN: SANDEEP SABOO PHONE NO : 408 321 9999 3047 ORCHARD PKWY. SE DECISION MADE: 11-AUG-10 SAN JOSE CA 95134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROTEKTOR 32 NATUS MEDICAL, INC. 510(k) NO: K093304(TRADITIONAL)
ATTN: GOLDY SINGH PHONE NO : 905 829 5300 2568 BRISTOL CIRCLE SE DECISION MADE: 11-AUG-10 OAKVILLE, ONTARIO CA L6H 5S1 510(k) STATEMENT DEVICE: COLLAGEN DENTAL MEMBRANE V COLLAGEN MATRIX, INC. 510(k) NO: K100156(TRADITIONAL)
ATTN: PEGGY HANSEN PHONE NO : 201 405 1477 509 COMMERCE ST. SE DECISION MADE: 11-AUG-10 FRANKLIN LAKES NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES PIONEER SURGICAL TECHNOLOGY 510(k) NO: K093692(TRADITIONAL)
ATTN: EMILY M DOWNS PHONE NO : 906 225 5602 375 RIVER PARK CIRCLE SE DECISION MADE: 11-AUG-10 MARQUETTE MI 49855 0627 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX STRYKER SPINE 510(k) NO: K100865(TRADITIONAL)
ATTN: KIMBERLY S LANE PHONE NO : 201 760 8215 2 PEARL COURT SE DECISION MADE: 11-AUG-10 ALLENDALE NJ 07401 1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOSPIRA INFUSION BLOOD SETS HOSPIRA, INC. 510(k) NO: K101677(SPECIAL)
ATTN: KAREN KEENER PHONE NO : 224 212 5316 375 N FIELD DRIVE SE DECISION MADE: 11-AUG-10 LAKE FOREST IL 60045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WATERLASE MD TURBO PLUS MODEL 7200XXX BIOLASE TECHNOLOGY, INC. 510(k) NO: K101658(TRADITIONAL)
ATTN: IOANA RIZOIU PHONE NO : 949 226 8144 4 CROMWELL SE DECISION MADE: 11-AUG-10 IRVINE CA 92618 1816 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WINGMAN EXTENDABLE TIP SUPPORT CATHETER REFLOW MEDICAL 510(k) NO: K101479(TRADITIONAL)
ATTN: REBECCA PINE PHONE NO : 760 809 5178 5311 FOXHOUND WAY SE DECISION MADE: 11-AUG-10 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMNI III PATIENT MONITOR INFINIUM MEDICAL 510(k) NO: K101052(TRADITIONAL)
ATTN: JOHN OBRIEN PHONE NO : 813 645 2855 962 ALLEGRO LN. SE DECISION MADE: 11-AUG-10 APOLLO BEACH FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 2048801-8 KEPLER MEDTEC 510(k) NO: K101660(TRADITIONAL)
ATTN: F. DAVID ROTHKOPF PHONE NO : 508 231 8842 200 HOMER AVE SE DECISION MADE: 11-AUG-10 ASHLAND MA 01721 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMBAT READY CLAMP COMBAT MEDICAL SYSTEMS, LLC 510(k) NO: K102025(TRADITIONAL)
ATTN: CALLEY HERZOG PHONE NO : 720 883 3633 13417 QUIVAS ST SE DECISION MADE: 11-AUG-10 WESTMINSTER CO 80234 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYBRID TROCAR SYSTEM AESCULAP, INC. 510(k) NO: K101937(SPECIAL)
ATTN: DENISE ADAMS PHONE NO : 610 984 9076 3773 CORPORATE PARKWAY SE DECISION MADE: 11-AUG-10 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITABLOCS VITA ZAHNFABRIK H. RAUTER GMBH & C510(k) NO: K102128(ABBREVIATED)
ATTN: ELIZABETH WOLFSEN PHONE NO : 714 961 6268 3150 EAST BIRCH STREET SE DECISION MADE: 11-AUG-10 BREA CA 92821 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: AESCULAP PEEK CRANIOFIX AESCULAP, INC. 510(k) NO: K091692(TRADITIONAL)
ATTN: LISA M BOYLE PHONE NO : 610 984 9274 3773 CORPORATE PARKWAY SE DECISION MADE: 12-AUG-10 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KYPH X HV-R BONE CEMENT MEDTRONIC INC. 510(k) NO: K093828(SPECIAL)
ATTN: MARY ROSE PHONE NO : 408 548 5203 1221 CROSSMAN AVENUE SE DECISION MADE: 12-AUG-10 SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT HANDPIECE HEADQUARTERS 510(k) NO: K100389(TRADITIONAL)
ATTN: TINA STEFFAINE-OAK PHONE NO : 717 335 7230 620 S. PLACENTIA AVE. SE DECISION MADE: 12-AUG-10 PLACENTIA CA 92870 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORLOCATE SYSTEM MODEL ORL 100 HALDOR ADVANCED TECHNOLOGIES LTD 510(k) NO: K100551(TRADITIONAL)
ATTN: SARIT GELBART GAL-ROM PHONE NO : 972 523 599870 107 SHAVEY TZION SE DECISION MADE: 12-AUG-10 PARDES HANNA IS 37052 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRE-POWDERED VINYL PATIENT EXAMINATION GLOVE, NON-STERILE JIANGSU SUNSHINE PLASTIC PRODUCTS,510(k) NO: K100977(TRADITIONAL)
ATTN: MICHAEL LEE PHONE NO : 886 228 096995 NO.45 MINSHENG RD, DANSHUI TWN SE DECISION MADE: 12-AUG-10 TAIPEI COUNTY TW 251 510(k) STATEMENT DEVICE: POWDER FREE NON-STERILE VINYL EXAMINATION GLOVE JIANGSU SUNSHINE PLASTIC PRODUCTS,510(k) NO: K100978(TRADITIONAL)
ATTN: MICHAEL LEE PHONE NO : 886 228 096995 NO.45 MINSHENG RD, DANSHUI TWN SE DECISION MADE: 12-AUG-10 TAIPEI COUNTY TW 251 510(k) STATEMENT DEVICE: AVS A-LAT PEEK SPACERS, MODELS 48750XXX, 48751XXX, 48752XXX, 48753XXX STRYKER SPINE 510(k) NO: K101051(TRADITIONAL)
ATTN: KIMBERLY S LANE PHONE NO : 201 760 8215 2 PEARL COURT SE DECISION MADE: 12-AUG-10 ALLENDALE NJ 07401 1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STAINLESS STEEL SPINAL SYSTEM THEKEN SPINE LLC 510(k) NO: K100970(TRADITIONAL)
ATTN: DALE DAVISON PHONE NO : 330 475 8609 1800 TRIPLETT BLVD. SE DECISION MADE: 12-AUG-10 AKRON OH 44306 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE VENUE 40 COMPACT DIAGNOSTIC ULTRASOUND GE MEDICAL SYSTEMS CHINA CO., LTD.510(k) NO: K102113(TRADITIONAL)
ATTN: YALAN WU PHONE NO : NO. 19 CHANGJIANG ROAD NATIONAL HISE DECISION MADE: 12-AUG-10 WUXI, JIANGSU PROVINCE CH 21402510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEM SONOSITE,INC. 510(k) NO: K101757(TRADITIONAL)
ATTN: MARY K MOORE PHONE NO : 425 951 1275 21919 30TH DRIVE SE. SE DECISION MADE: 12-AUG-10 BOTHELL WA 98021 3904 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NON-ABLATIVE WRINKLE TREATENT HANDPIECE MODLE PELLEVE' ELLMAN INT'L INC. 510(k) NO: K101967(SPECIAL)
ATTN: JONATHAN ACHENBACH PHONE NO : 800 835 5355 3333 ROYAL AVENUE SE DECISION MADE: 12-AUG-10 OCEANSIDE NY 11572 3625 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING) ENVIRONMENTAL TECTONICS CORP. 510(k) NO: K092991(TRADITIONAL)
ATTN: GENE DAVIS PHONE NO : 215 355 9100 125 JAMES WAY SE DECISION MADE: 13-AUG-10 SOUTHAMPTON PA 18966 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: ECHO TD-3227 DUAL BLOOD PRESSURE/BLOOD GLUCOSE METER TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K092875(SPECIAL)
ATTN: DEBRA LIANG PHONE NO : 886 266 258188 6F, NO. 127, WUGONG 2ND RD WUGU TOSE DECISION MADE: 13-AUG-10 TAIPEI COUNTY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POSTURETEK PERSEUS ALTHETICS,LLC 510(k) NO: K093553(TRADITIONAL)
ATTN: KEITH BARRITT PHONE NO : 202 783 5070 1425 K STREET, N.W. SUITE 1100 SE DECISION MADE: 13-AUG-10 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLASMALIPO/PLASMA D30 LSER SURGICAL DEVICE JM SYSTEM CO., LTD. 510(k) NO: K100098(TRADITIONAL)
ATTN: KEVIN WALLS, RAC PHONE NO : 720 962 5412 5401 S. COTTONWOOD CT. SE DECISION MADE: 13-AUG-10 GREENWOOD VILLAGE CO 80121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01 PHADIA US INC. 510(k) NO: K093459(TRADITIONAL)
ATTN: MARTIN ROBERT MANN PHONE NO : 269 492 1957 4169 COMMERCIAL AVE. SE DECISION MADE: 13-AUG-10 PORTAGE MI 49002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECTRA SERIES BREAST PUMP UZINMEDICARE CO. 510(k) NO: K093145(TRADITIONAL)
ATTN: YONG J CHOI PHONE NO : 82 313 220132 503 -2 CHANG-RI, NAMSA -MYEON SE DECISION MADE: 13-AUG-10 YONGIN KS 449-885 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PILOT DIODE LASER, MODEL 002-00139 CAO GROUP, INC. 510(k) NO: K100143(TRADITIONAL)
ATTN: ROBERT LARSEN PHONE NO : 801 256 9282 4628 WEST SKYHAWK DRIVE SE DECISION MADE: 13-AUG-10 WEST JORDAN UT 84084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INQUIRY AFOCUSII DIAGNOSTIC CATHETER ST. JUDE MEDICAL 510(k) NO: K101623(TRADITIONAL)
ATTN: QUYNH PHUONG LE PHONE NO : 949 769 5058 2375 MORSE AVENUE SE DECISION MADE: 13-AUG-10 IRVINE CA 92614 6233 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPAPLUS THE BINDING SITE, LTD. 510(k) NO: K100179(TRADITIONAL)
ATTN: JAY GELLER PHONE NO : 310 997 9966 12100 WILSHIRE BL., SUITE 500 SE DECISION MADE: 13-AUG-10 LOS ANGELES CA 90025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX BSD MEDICAL CORP. 510(k) NO: K100786(TRADITIONAL)
ATTN: DIXIE TOOLSON SELLS PHONE NO : 801 972 5555 148 S. 1200 E. SE DECISION MADE: 13-AUG-10 SALT LAKE CITY UT 84102 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 2008 HEMODIALYSIS SORBENT SYSTEM RENAL SOLUTIONS INC. 510(k) NO: K093362(ABBREVIATED)
ATTN: DAVID J VANELLA PHONE NO : 724 772 6900 770 COMMONWEALTH DRIVE SUITE 101 SE DECISION MADE: 13-AUG-10 WARRENDALE PA 15086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PICC WAND PEELABLE SAFETY INTRODUCER ACCESS SCIENTIFIC, INC. 510(k) NO: K101150(SPECIAL)
ATTN: ALBERT MISAJON PHONE NO : 858 259 8333 12526 HIGH BLUFF DRIVE SUITE 360 SE DECISION MADE: 13-AUG-10 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FASTPACK TSH IMMUNOASSAY QUALIGEN, INC. 510(k) NO: K101390(SPECIAL)
ATTN: MICHAEL S POIRIER PHONE NO : 760 918 9165 2042 CORTE DEL NOGAL SE DECISION MADE: 13-AUG-10 CARLSBAD CA 92011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GAUNYING INFRARED LAMP FOSHAN GAUNYING ELECTRONICS CO., L510(k) NO: K102149(TRADITIONAL)
ATTN: LADI LEE PHONE NO : 867 578 3107610 HI-TECH INDUSTRIAL DEVELOPMENT SE DECISION MADE: 13-AUG-10 FOSHAN, GUANGDONG CH 52800 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS APEX BIOTECHNOLOGY CORP. 510(k) NO: K102037(SPECIAL)
ATTN: HSUE-MEI LEE PHONE NO : 886 3 5641952 NO. 7, LI-HSIN ROAD V, HSINCHU SCISE DECISION MADE: 13-AUG-10 HSINCHU TW 30078 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH HUGE DENTAL MATERIAL CO., LTD. 510(k) NO: K101029(TRADITIONAL)
ATTN: JING LI PHONE NO : 302 339 8107 3500 SOUTH DUPONT HIGHWAY SE DECISION MADE: 16-AUG-10 DOVER DE 19901 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATLANTIS ABUTMENT FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT ASTRA TECH, INC. 510(k) NO: K101004(TRADITIONAL)
ATTN: BETSY A BROWN PHONE NO : 847 560 4406 8944 TAMAROA TERR. SE DECISION MADE: 16-AUG-10 SKOKIE IL 60076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMC SURGICAL FACE MASK INTERNATIONAL MEDSURG CONNECTION 510(k) NO: K100846(TRADITIONAL)
ATTN: PETER KIM PHONE NO : 847 619 9926 935 N PLUM GROVE RD, STE F SE DECISION MADE: 16-AUG-10 SCHAUMBURG IL 60173 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HUMAN IGA2 KIT FOR USE ON THE SPAPLUS THE BINDING SITE GROUP LTD 510(k) NO: K100588(TRADITIONAL)
ATTN: JAY GELLER PHONE NO : 310 997 9966 12100 WILSHIRE BL., SUITE 500 SE DECISION MADE: 16-AUG-10 LOS ANGELES CA 90025 510(k) STATEMENT DEVICE: 21.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODEL MS3112 (MDL2128A) TOTOKU ELECTRIC CO., LTD. 510(k) NO: K090947(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 81 268 345469 300 OYA, UEDA SE DECISION MADE: 16-AUG-10 NAGANO JA 386-0192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LANX FACET SCREW SYSTEM LANX, INC. 510(k) NO: K101364(TRADITIONAL)
ATTN: MICHAEL FUNK PHONE NO : 303 443 7500 390 INTERLOCKEN CRESCENT SUITE 890SE DECISION MADE: 16-AUG-10 BROOMFIELD CO 80021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNGO TRUED SOFTWARE SIEMENS MEDICAL SOLUTIONS 510(k) NO: K101749(TRADITIONAL)
ATTN: JAMES E KUHN PHONE NO : 610 448 3006 20 VALLEY STREAM PARKWAY SE DECISION MADE: 16-AUG-10 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: REPLENS LONG-LASTING VAGINAL MOISTURIZER (35G TUBE WITH REUSABLE APPLICATOR) MODEL: 83035 LIL DRUG STORE PRODUCTS, INC. 510(k) NO: K101098(TRADITIONAL)
ATTN: PATRICIA MILLER PHONE NO : 319 294 3745 1201 CONTINENTAL PL. N.E. SE DECISION MADE: 17-AUG-10 CEDAR RAPIDS IA 52402 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: LIGAMENTOTAXOR AREX USA 510(k) NO: K094043(TRADITIONAL)
ATTN: ELLEN HOKANSON PHONE NO : 610 584 6870 1335 MERRYBROOK RD. SE DECISION MADE: 17-AUG-10 COLLEGEVILLE PA 19426 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRIMAL OK INTERSPINOUS FUSION SYSTEM OSTEOMED L.P. 510(k) NO: K100354(TRADITIONAL)
ATTN: KAREN E WARDEN PHONE NO : 440 729 8457 8202 SHERMAN RD SE DECISION MADE: 17-AUG-10 CHESTERLAND OH 44026 2141 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABREU, MODEL 700 BRAIN TUNNELGENIX TECHNOLOGIES COR510(k) NO: K100843(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 239 234 1735 8870 RAVELLO CT SE DECISION MADE: 17-AUG-10 NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPLENS LONG-LASTING VAGINAL MOISTURIZER (PRE-FILLED APPLICATOR) LIL DRUG STORE PRODUCTS, INC. 510(k) NO: K101241(TRADITIONAL)
ATTN: PATRICIA L MILLER PHONE NO : 319 294 3745 1201 CONTINENTAL PL. N.E. SE DECISION MADE: 17-AUG-10 CEDAR RAPIDS IA 52402 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PHARMACARIBE INHALED SALINE SOLUTIONS PHARMACARIBE 510(k) NO: K101424(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DRIVE SE DECISION MADE: 17-AUG-10 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER - FREE PATIENT EXAMINATION GLOVES ZIBIO YINGJIE MEDICAL PRODUCTS CO.510(k) NO: K101565(TRADITIONAL)
ATTN: FRANK LIU PHONE NO : 909 548 4828 12390 EAST AVE. SE DECISION MADE: 17-AUG-10 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NITRIL EXAM GLOVE, PRE-POWERED COLOR WHITE, NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE JIANGSU SUNSHINE PLASTIC PRODUCTS,510(k) NO: K100975(TRADITIONAL)
ATTN: MICHAEL LEE PHONE NO : 886 228 096995 NO.45 MINSHENG RD, DANSHUI TWN SE DECISION MADE: 17-AUG-10 TAIPEI COUNTY TW 251 510(k) STATEMENT DEVICE: RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER ACCELETRONICS DIGITAL IMAGING, LLC510(k) NO: K101038(TRADITIONAL)
ATTN: STEVE SCHWARZ PHONE NO : 610 524 3399 602 GORDON DR SE DECISION MADE: 17-AUG-10 EXTON PA 19341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STELLARIS PC VISION ENHANCEMENT SYSTEM BAUSCH & LOMB, INC. 510(k) NO: K101325(TRADITIONAL)
ATTN: NED LUCE PHONE NO : 585 338 6368 1400 NORTH GOODMAN ST. SE DECISION MADE: 17-AUG-10 ROCHESTER NY 14609 3547 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: HUMAPEN LUXURA HD ELI LILLY AND COMPANY 510(k) NO: K100988(TRADITIONAL)
ATTN: STEVEN T JOHNSON PE, MBA PHONE NO : 317 433 4685 LILLY CORPORATE CENTER SE DECISION MADE: 17-AUG-10 INDIANAPOLIS IN 46285 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LO-50 LED LIGHT SOURCE FIBEROPTICS TECHNOLOGY, INC. 510(k) NO: K102167(TRADITIONAL)
ATTN: ALLAN GUILLOTTE PHONE NO : 860 928 0443 1 QUASSETT ROAD SE DECISION MADE: 17-AUG-10 POMFRET CT 06258 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DIGITAL RADIOGRAPHY CANON, INC.-MEDICAL EQUIPMENT GROU510(k) NO: K102012(SPECIAL)
ATTN: KOJI KUBO PHONE NO : 814 254 81253 3F 2-17-6 AKEBONO-CHO SE DECISION MADE: 17-AUG-10 TACHIKAWA-SHI, TOKYO JA 190-001510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CURIEPACS (DICOM PACS SOFTWARE) MOKSHA DIGITAL SOFTWARE PVT LIMITE510(k) NO: K102148(TRADITIONAL)
ATTN: DEEPAK SHARMA PHONE NO : #1611, JANARDHANA TOWERS 7TH CROSSSE DECISION MADE: 17-AUG-10 HSR LAYOUT, BANGALORE IN 560034510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: HS/HG PROSTHETIC SYSTEM OSSTEM IMPLANT CO.,LTD 510(k) NO: K100245(SPECIAL)
ATTN: PATRICK LIM PHONE NO : 888 678 0001 85 BEN FAIRLESS DR. SE DECISION MADE: 17-AUG-10 FAIRLESS HILLS PA 19030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTA MAXIGRO AND REGIGRO OSTA TECHNOLOGIES 510(k) NO: K091424(ABBREVIATED)
ATTN: JAY MANSOUR PHONE NO : 678 908 8180 845 ARONSON LAKE COURT SE DECISION MADE: 18-AUG-10 ROSWELL GA 30075 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEONATE ARRAY COILS LMT MEDICAL SYSTEMS GMBH 510(k) NO: K091047(TRADITIONAL) ATTN: KRISTINA LUETJE PHONE NO : 49 451 5809814 OSTERWEIDE 8 SE DECISION MADE: 18-AUG-10 LUEBECK GM 23562 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODULAR ENDOSCOPE SIALO TECHNOLOGY, LTD. 510(k) NO: K093785(TRADITIONAL)
ATTN: AHAVA STEIN/ EYAL OZERI PHONE NO : 972 976 70002 20 HATA'AS STR., SUITE 102 SE DECISION MADE: 18-AUG-10 KFAR SABA IS 44425 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAMBERGSLEEPWELL- SMARTRUSION (LSW-S) STEVEN B. LAMBERG, DDS 510(k) NO: K101709(ABBREVIATED)
ATTN: EMILY B ROSSITER PHONE NO : 800 966 9376 800 E. LEIGH STREET SUITE 206-5 SE DECISION MADE: 18-AUG-10 RICHMOND VA 23219 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIMMER DTO PIN PRESS INSTRUMENT ZIMMER SPINE, INC. 510(k) NO: K101704(SPECIAL)
ATTN: TIM CRABTREE PHONE NO : 952 857 5631 7375 BUSH LAKE RD. SE DECISION MADE: 18-AUG-10 MINNEAPOLIS MN 55439 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NATURALASE DIODE LASER FAMILY NATURALASE MODEL NL980, NATURALASE DIODE LASER FAMILY NATURALASE NL810 FOCUS MEDICAL, LLC. 510(k) NO: K101152(TRADITIONAL)
ATTN: JOHN LEE PHONE NO : 203 730 8885 23 FRANCIS J. CLARKE CIRCLE SE DECISION MADE: 18-AUG-10 BETHEL CT 06801 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BONEOPTIMIZER CURASAN AG 510(k) NO: K100841(SPECIAL)
ATTN: CYNTHIA J.M. NOLTE, PH.D. PHONE NO : 919 859 4207 49 PLAIN STREET SE DECISION MADE: 19-AUG-10 NORTH ATTLEBORO MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNERGY CT PICC HEALTH LINE INTERNATIONAL CORPORAT510(k) NO: K101329(TRADITIONAL)
ATTN: NOLA BENSTOG PHONE NO : 800 177 3779 803 N. 1250 W. SUITE 1 SE DECISION MADE: 19-AUG-10 CENTERVILLE UT 84014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE KIRWAN SURGICAL PRODUCTS, INC. 510(k) NO: K100912(TRADITIONAL)
ATTN: KEVIN P PRARIO PHONE NO : 781 834 6600 180 ENTERPRISE DR. SE DECISION MADE: 19-AUG-10 MARSHFIELD MA 02050 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GRANDIO FLOW VOCO GMBH 510(k) NO: K101213(TRADITIONAL)
ATTN: M PLAUMANN PHONE NO : 494 721 719200 ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 19-AUG-10 CUXHAVEN GM D-27472 510(k) STATEMENT DEVICE: SPI VARIOMULTI ANGLED ABUTMENT THOMMEN MEDICAL, AG 510(k) NO: K101798(SPECIAL)
ATTN: LINDA K SCHULZ PHONE NO : 858 792 1235 11234 EL CAMINO REAL, SUITE 200 SE DECISION MADE: 19-AUG-10 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STN PROBE SUMMIT DOPPLER SYSTEMS, INC. 510(k) NO: K101816(SPECIAL)
ATTN: KEN JARRELL PHONE NO : 303 423 7572 4680 TABLE MOUNTAIN DR #150 SE DECISION MADE: 19-AUG-10 GOLDEN CO 80403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS STERILMED, INC. 510(k) NO: K101789(TRADITIONAL)
ATTN: GARRETT AHLBORG PHONE NO : 763 488 3483 11400 73RD AVE. N. SE DECISION MADE: 19-AUG-10 MAPLE GROVE MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BBL CHROMAGAR MRSA II BECTON DICKINSON & CO. 510(k) NO: K092767(TRADITIONAL)
ATTN: PAUL SWIFT PHONE NO : 410 316 4905 7 LOVETON CIR. SE DECISION MADE: 20-AUG-10 SPARKS MD 21152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIRCONIA SYRINGE NEEDLE KUO TAI HOSPITAL MANAGEMENTS & CON510(k) NO: K093043(TRADITIONAL)
ATTN: CHAO-SHENT CHAO PHONE NO : 886 237 652536 2F-1, NO.27, TAYOU RD., SONGSHAN DSE DECISION MADE: 20-AUG-10 TAIPEI TW 10585 510(k) STATEMENT DEVICE: PROCEDURE REHEARSAL STUDIO SIMBIONIX LTD. 510(k) NO: K093269(TRADITIONAL)
ATTN: SHOSHANA FRIEDMAN PHONE NO : 704 899 0092 1914 J N PEASE PL. SE DECISION MADE: 20-AUG-10 CHARLOTTE NC 28262 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015 ENCISION, INC. 510(k) NO: K093622(TRADITIONAL)
ATTN: JUDITH V KING PHONE NO : 303 444 2600 6797 WINCHESTER CIR. SE DECISION MADE: 20-AUG-10 BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOBELPROCERA IPS E.MAX CROWN NOBEL BIOCARE AB 510(k) NO: K100512(TRADITIONAL)
ATTN: HERBERT CRANE PHONE NO : 714 282 4800 22715 SAVI RANCH PARKWAY SE DECISION MADE: 20-AUG-10 YORBA LINDA CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLIGHT 60 VENTILATOR, MODEL F-60 FLIGHT MEDICAL LTD. 510(k) NO: K100753(TRADITIONAL)
ATTN: SHOSHANA FRIEDMAN PHONE NO : 704 899 0092 1914 JN PEASE PL SE DECISION MADE: 20-AUG-10 CHARLOTTE NC 28262 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSIRIX MD PIXMEO SARL 510(k) NO: K101342(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940 300 8601 1600 MANCHESTER WAY SE DECISION MADE: 20-AUG-10 CORINTH TX 76210 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3 ESSEX INDUSTRIES, INC. 510(k) NO: K101272(TRADITIONAL)
ATTN: KEN SEISE PHONE NO : 314 832 8077 8007 CHIVVIS DRIVE SE DECISION MADE: 20-AUG-10 ST. LOUIS MO 63123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML) INVIRO MEDICAL DEVICES, INC. 510(k) NO: K101359(SPECIAL)
ATTN: JIM BARLEY PHONE NO : 949 481 5713 1755 NORTH BROWN ROAD SUITE 150 SE DECISION MADE: 20-AUG-10 LAWRENCEVILLE GA 30043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DENTAL HANDPIECES, MODELS: KARAM STD/MINI; BREEZE STD/MINI: KARAM 45; DEXOR 45; KARAM 4H COUPLING AEROBINE, INC 510(k) NO: K101717(TRADITIONAL)
ATTN: YONG W KIM PHONE NO : 858 277 1700 7670 OPPORTUNITY ROAD SUITE 100 SE DECISION MADE: 20-AUG-10 SAN DIEGO CA 92111 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U PERKINELMER, INC. 510(k) NO: K093916(TRADITIONAL)
ATTN: KAY TAYLOR PHONE NO : 317 418 1735 8275 CARLOWAY ROAD SE DECISION MADE: 23-AUG-10 INDIANAPOLIS IN 46236 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LITE ART SHOFU DENTAL CORP. 510(k) NO: K101621(TRADITIONAL)
ATTN: DAVID P MORAIS PHONE NO : 760 736 3277 1225 STONE DR. SE DECISION MADE: 23-AUG-10 SAN MARCOS CA 92078 510(k) STATEMENT DEVICE: LUMENVU CATHETER GUIDANCE SYSTEM SONOSITE,INC. 510(k) NO: K093510(TRADITIONAL)
ATTN: JANICE HOGAN PHONE NO : 267 675 4600 1835 MARKET ST., 29TH FL. SE DECISION MADE: 23-AUG-10 PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BEAUTIFIL FLOW PLUS SHOFU DENTAL CORP. 510(k) NO: K101603(TRADITIONAL)
ATTN: DAVID P MORAIS PHONE NO : 760 736 3277 1225 STONE DR. SE DECISION MADE: 23-AUG-10 SAN MARCOS CA 92078 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCUFIT DENTAL IMPLANT ABUTMENTS & SCREWS RADIANT EXPRESS LLC 510(k) NO: K101068(TRADITIONAL)
ATTN: RYAN CHIOU PHONE NO : 732 346 1000 342 RARITAN CENTER PARKWAY SE DECISION MADE: 23-AUG-10 EDISON NJ 08837 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CELL-CHEX STRECK 510(k) NO: K101335(TRADITIONAL)
ATTN: KERRIE OETTER PHONE NO : 402 537 5215 7002 SOUTH 109TH ST. SE DECISION MADE: 23-AUG-10 OMAHA NE 68128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INNOVIA INNOPORT LAPAROSCOPIC ACCESS PORT INNOVIA, LLC 510(k) NO: K093783(TRADITIONAL)
ATTN: BRUCE WEBER PHONE NO : 305 378 2651 12415 SW 136 AVENUE UNIT 3 SE DECISION MADE: 23-AUG-10 MIAMI FL 33186 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BK BLANK MODEL 20,40,65,90 BK MEDENT CO., LTD. 510(k) NO: K101875(TRADITIONAL)
ATTN: PRISCILLA CHUNG PHONE NO : 714 844 2612 2341 W. CRESCENT AVE #3 SE DECISION MADE: 23-AUG-10 ANAHEIM CA 92801 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470 BOSTON SCIENTIFIC CORP. 510(k) NO: K102082(SPECIAL)
ATTN: LAURIE PANNELLA PHONE NO : 508 683 4872 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 23-AUG-10 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INNOVATIVE MED MULTI WAVE LIGHT THERAPY SYSTEM INNOVATIVE MED, INC. 510(k) NO: K093204(TRADITIONAL)
ATTN: JEFFREY KOLSTER PHONE NO : 949 458 1897 4 AUTRY, UNIT B SE DECISION MADE: 23-AUG-10 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM BIO-RAD LABORATORIES 510(k) NO: K093954(TRADITIONAL)
ATTN: JUANG WANG PHONE NO : 510 741 4609 BIOPLEX 2200 DIVISION 5500 EAST SESE DECISION MADE: 24-AUG-10 BENICIA CA 94510 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LARYNGEAL SURFACE ELECTRODE SPES MEDICA S.R.L. 510(k) NO: K093373(TRADITIONAL)
ATTN: ALFREDO SPADAVECHIA PHONE NO : 390 828 614191 VIA EUROPA-ZONA INDUSTRIALE SE DECISION MADE: 24-AUG-10 BATTIPAGLIA IT 84091 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES HEBEI HANDFORM PLASTIC PRODUCTS CO510(k) NO: K101358(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441 ROOM 1606 BLDG 1 JIANXIANG YUAN NOSE DECISION MADE: 24-AUG-10 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: METAFLEXCOIL NEOCOIL, LLC 510(k) NO: K101632(TRADITIONAL)
ATTN: BRIAN BROWN PHONE NO : 262 347 1250 N27 W23910A PAUL RD. SE DECISION MADE: 24-AUG-10 PEWAUKEE WI 53072 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MANTIS SPINAL SYSTEM & MANTIS REDUX SPINAL SYSTEM STRYKER SPINE 510(k) NO: K102235(SPECIAL)
ATTN: CURTIS TRUESDALE PHONE NO : 201 760 8296 2 PEARL COURT SE DECISION MADE: 24-AUG-10 ALLENDALE NJ 07401 1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEGEND POWER ADAPTER MODEL: 6475000 MEDTRONIC SOFAMOR DANEK 510(k) NO: K101168(TRADITIONAL)
ATTN: THERESA LEISTER PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 24-AUG-10 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K093175(TRADITIONAL)
ATTN: HOWARD MANN PHONE NO : 267 566 3078 1 CONGRESSIONAL DRIVE APT C, SE DECISION MADE: 25-AUG-10 GREENVILLE DE 19807 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ETEST MOXIFLOXACIN 0.002-32 UG/ML AB BIOMERIEUX 510(k) NO: K093604(TRADITIONAL)
ATTN: ASA KARLSSON PHONE NO : 468 730 0760 DALVAGEN 10 SE DECISION MADE: 25-AUG-10 SOLNA SW 16956 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUFLO CATHETER (HEPARIN COATED) THERMOPEUTIX INC. 510(k) NO: K093847(SPECIAL)
ATTN: THOMAS SCHROEDER PHONE NO : 858 549 7160 9925B BUSINESS PARK AVE. SE DECISION MADE: 25-AUG-10 SAN DIEGO CA 92131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGIMAX/ SURGIMAX PLUS ELLIQUENCE LLC 510(k) NO: K100390(TRADITIONAL)
ATTN: JOSEPH AZARY PHONE NO : 203 922 0105 80 SHELTON TECHNOLOGY CENTER SE DECISION MADE: 25-AUG-10 SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TACAMO MANUAL WHEELCHAIR DALTON INSTRUMENT CORP. 510(k) NO: K101719(ABBREVIATED)
ATTN: MEI LEIN PHONE NO : 469 522 1200 3788 ARAPAHO RD SE DECISION MADE: 25-AUG-10 ADDIISON TX 75001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAPIDVUE HCG TEST QUIDEL CORPORATION 510(k) NO: K102175(SPECIAL)
ATTN: MICHELLE BODIEN PHONE NO : 858 552 1100 10165 MCKELLAR COURT SE DECISION MADE: 25-AUG-10 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE COOK, INC. 510(k) NO: K101728(SPECIAL)
ATTN: SEAN WERNER PHONE NO : 812 339 2235 750 DANIELS WAY PO BX 489 SE DECISION MADE: 25-AUG-10 BLOOMINGTON IN 47402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MDPO FRAME SYSTEM MDPO, LLC 510(k) NO: K093753(TRADITIONAL)
ATTN: MARIE MARLOW PHONE NO : 703 562 9800 901 KING ST. SUITE 200 SE DECISION MADE: 26-AUG-10 ALEXANDRIA VA 22314 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254) LUMINEX MOLECULAR DIAGNOSTICS, INC510(k) NO: K093420(TRADITIONAL)
ATTN: GLORIA LEE PHONE NO : 416 593 4323 439 UNIVERSITY AVE. SE DECISION MADE: 26-AUG-10 TORONTO, ONTARIO CA M5G 1Y8 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STAR/VENT INTERNAL HEX SCREW IMPLANT PARK DENTAL RESEARCH CORP. 510(k) NO: K082800(TRADITIONAL)
ATTN: DANIEL J MANELLI PHONE NO : 202 885 5548 5335 WISCONSIN AVE. NW SUITE 440 SE DECISION MADE: 26-AUG-10 WASHINGTON DC 20015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CELLTRACKS AUTOPREP SYSTEM MODEL:9541 VERIDEX, LLC 510(k) NO: K100684(TRADITIONAL)
ATTN: SARAH MCMANUS PHONE NO : 908 704 3920 1001 US HIGHWAY 202 NORTH SE DECISION MADE: 26-AUG-10 RARITAN NJ 08869 0606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T TRANS1 INCORPORATED 510(k) NO: K100210(TRADITIONAL)
ATTN: CHERYL WAGONER PHONE NO : 910 332 1700 411 LANDMARK DR. SE DECISION MADE: 26-AUG-10 WILMINGTON NC 28412 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-CHLORINATED, POLYMER COATED POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES AND PROTEIN LABELING CLAIM OF LATEXX MANUFACTURING SDN.BHD. 510(k) NO: K101645(TRADITIONAL)
ATTN: TERENCE LIM SIN KOOI PHONE NO : 605 891 1111 PT. 5054, KAMUNTING INDUSTRIAL ESTSE DECISION MADE: 26-AUG-10 TAIPING, PERAK MY 34600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHIMADZU COLLIMATOR R-20J SHIMADZU CORP. 510(k) NO: K101036(ABBREVIATED)
ATTN: DONALD KARLE PHONE NO : 310 217 8855 20101 SOUTH VERMONT AVE. SE DECISION MADE: 26-AUG-10 TORRANCE CA 90502 1328 510(k) STATEMENT DEVICE: ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E BISCO, INC. 510(k) NO: K101485(TRADITIONAL)
ATTN: MICHELLE SCHULTZ- TAING PHONE NO : 847 534 6000 1100 WEST IRVING PARK RD. SE DECISION MADE: 26-AUG-10 SCHAUMBURG IL 60193 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503 CONMED LINVATEC 510(k) NO: K101100(TRADITIONAL)
ATTN: JOHN CUSACK PHONE NO : 727 399 5562 11311 CONCEPT BOULEVARD SE DECISION MADE: 26-AUG-10 LARGO FL 33773 4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JOURNEY CR KNEE SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K101499(ABBREVIATED)
ATTN: SHEREEN MYERS PHONE NO : 901 399 6325 1450 BROOKS RD. SE DECISION MADE: 26-AUG-10 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INBONE II TOTAL ANKLE REPLACEMENT WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K100886(TRADITIONAL)
ATTN: KELSEY LEE PHONE NO : 901 290 5909 5677 AIRLINE RD. SE DECISION MADE: 26-AUG-10 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TENZING SYSTEM MAZOR SURGICAL TECHNOLOGIES LTD. 510(k) NO: K102130(SPECIAL)
ATTN: AHAVA STEIN PHONE NO : 972 9 7670002 20 HATA'AS ST. SE DECISION MADE: 26-AUG-10 KFAR SABA IS 44425 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K100141(TRADITIONAL)
ATTN: JUDITH CAMPBELL PHONE NO : 610 448 4918 51 VALLEY STREAM PKWY. SE DECISION MADE: 27-AUG-10 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FS ALIGNER ALLESEE ORTHODONTIC APPLIANCES 510(k) NO: K093821(TRADITIONAL)
ATTN: WENDY GARMAN PHONE NO : 714 516 7602 1717 WEST COLLINS AVENUE SE DECISION MADE: 27-AUG-10 ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229 ORIGIO A/S 510(k) NO: K100367(TRADITIONAL)
ATTN: RONALD G LEONARDI PHONE NO : 858 586 0751 9915 CAM, CHIRIMOLLA SE DECISION MADE: 27-AUG-10 SAN DIEGO CA 92131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504 ARROW INTL., INC. 510(k) NO: K100635(TRADITIONAL)
ATTN: TRACY MADDOCK PHONE NO : 610 378 0131 2400 BERNVILLE RD. SE DECISION MADE: 27-AUG-10 READING PA 19605 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCH BP HOME N BP3MX1-4 MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K100763(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949 706 7456 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 27-AUG-10 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUASAR BLUE LIGHT THERAPY SYSTEM SILVER BAY, LLC 510(k) NO: K093963(TRADITIONAL)
ATTN: PETER NESBITT PHONE NO : 941 306 5812 1431 TALLEVAST ROAD SE DECISION MADE: 27-AUG-10 SARASOTA FL 34243 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ST AIA PACK HBA1C TOSOH BIOSCIENCE, INC. 510(k) NO: K100304(TRADITIONAL)
ATTN: JUDITH OGDEN PHONE NO : 650 636 8112 6000 SHORELINE COURT SUITE 101 SE DECISION MADE: 27-AUG-10 SOUTH SAN FRANCISCO CA 94080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCU-CHEK ULTRFLEX INFUSION SET ROCHE DIAGNOSTICS CORP. 510(k) NO: K101196(SPECIAL)
ATTN: SCOTT THIEL PHONE NO : 317 521 3362 9115 HAGUE RD. SE DECISION MADE: 27-AUG-10 INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, MAQUET CRITICAL CARE AB 510(k) NO: K101199(TRADITIONAL)
ATTN: WHITNEY TORNING PHONE NO : 973 709 7994 45 BORBOUR POND DRIVE SE DECISION MADE: 27-AUG-10 WAYNE NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIDWEST REPROCESSING CENTER REPROCESSED VENODYNE SLEEVES/FOOT CUFFS MIDWEST REPROCESSING CENTER LLC 510(k) NO: K101702(TRADITIONAL)
ATTN: JEROME JAMES PHONE NO : 205 314 3920 434 INDUSTRIAL LANE SE DECISION MADE: 27-AUG-10 BIRMINGHAM AL 35211 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIDWEST REPROCESSING CENTER REPROCESSED SCD EXPRESS SLEEVES/ FOOT CUFFS, MIDWEST REPROCESSING CENTER REPROCESSED ALP SLE MIDWEST REPROCESSING CENTER LLC 510(k) NO: K101330(TRADITIONAL)
ATTN: JEROME JAMES PHONE NO : 205 314 3920 434 INDUSTRIAL LANE SE DECISION MADE: 27-AUG-10 BIRMINGHAM AL 35211 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TX1 TISSUE REMOVAL SYSTEM AMERICAN OPTISURGICAL, INC. 510(k) NO: K101561(TRADITIONAL)
ATTN: DAVID SALZBERG PHONE NO : 949 580 1266 25501 ARCTIC OCEAN SE DECISION MADE: 27-AUG-10 LAKE FOREST CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH NOVA BIOMEDICAL CORP. 510(k) NO: K101633(TRADITIONAL)
ATTN: PAUL W MACDONALD PHONE NO : 781 894 0800 200 PROSPECT ST. SE DECISION MADE: 27-AUG-10 WALTHAM MA 02454 9141 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR LEVITRONIX LLC. 510(k) NO: K102129(SPECIAL)
ATTN: FARZAD PARSAIE PHONE NO : 781 466 6553 45 FIRST AVE. SE DECISION MADE: 27-AUG-10 WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS PRECICONTROL MULTIMARKER ROCHE DIAGNOSTICS 510(k) NO: K102157(TRADITIONAL)
ATTN: SARAH BAUMANN PHONE NO : 317 521 3952 9115 HAGUE ROAD PO BOX 50416 SE DECISION MADE: 27-AUG-10 INDIANAPOLIS IN 46250 0416 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUR-G GLOV AND MAXITEX TERANG NUSA SDN BHD 510(k) NO: K102119(SPECIAL)
ATTN: ROBERT HILL PHONE NO : 60 9 7747171 1, JALAN 8, PENGKALAN CHEPA 2 IND.SE DECISION MADE: 27-AUG-10 KOTA BHARU, KELANTAN MY 16100 510(k) STATEMENT DEVICE: HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M- HEINE OPTOTECHNIK GMBH & CO. KG. 510(k) NO: K101892(TRADITIONAL)
ATTN: THOMAS WEBER PHONE NO : 494 047 10360 BEIM STROHHAUSE 27 SE DECISION MADE: 27-AUG-10 HAMBURG GM 20097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BELIMED STEAM STERILIZER, MODEL MST-V 3-3-6 BELIMED SAUTER AG 510(k) NO: K100622(ABBREVIATED)
ATTN: HANS STADLER PHONE NO : 41 71 6448500 ZELGSTRASSE 8 SE DECISION MADE: 27-AUG-10 SULGEN (TG) SZ CH-8583 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ENDOTRACHEAL TUBE CHANGERS INSTRUMENTATION INDUSTRIES, INC. 510(k) NO: K102127(SPECIAL)
ATTN: DORIS WALTER PHONE NO : 412 854 1133 2990 INDUSTRIAL BLVD. SE DECISION MADE: 27-AUG-10 BETHEL PARK PA 15102 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT MEDICAL DEVICE TECHNOLOGIES, INC. 510(k) NO: K101832(TRADITIONAL)
ATTN: TRUDY D ESTRIDGE PHONE NO : 352 338 0440 3600 S.W. 47TH AVE. SE DECISION MADE: 27-AUG-10 GAINESVILLE FL 32608 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLOOD PRESSURE METER, MODEL CH-609 CITIZEN SYSTEMS JAPAN CO., LTD. 510(k) NO: K100055(SPECIAL)
ATTN: NATHAN A BEAVER PHONE NO : 202 295 4039 3000 K STREET NW SUITE 600 SE DECISION MADE: 30-AUG-10 WASHINGTON DC 20007 5143 510(k) STATEMENT DEVICE: CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C CANADA ENDOSCOPE CORPORATION 510(k) NO: K093725(TRADITIONAL)
ATTN: ROGER LECLERC PHONE NO : 905 509 8543 1590 OAKBURN ST SE DECISION MADE: 30-AUG-10 PICKERING, ON CA L1V 6M9 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASCENSION MODULAR TOTAL SHOULDER SYSTEM ASCENSION ORTHOPEDICS, INC. 510(k) NO: K100448(TRADITIONAL)
ATTN: STANLEY J HARRIS PHONE NO : 512 836 5001 8700 CAMERON RD., STE. 100 SE DECISION MADE: 30-AUG-10 AUSTIN TX 78754 3832 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 1ML UNITRACT TUBERCULIN SYRINGE, 25G X 5/8, MODEL 132AS1-1, 1ML UNITRACT TUBERCULIN SYRINGE UNILIFE MEDICAL SOLUTIONS LIMITED 510(k) NO: K100998(TRADITIONAL)
ATTN: MELISSA L DEHASS PHONE NO : 717 938 9323 633 LOWTHER RD. SE DECISION MADE: 30-AUG-10 LEWISBERRY PA 17339 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3DHJD CAMERA SYSTEM MODEL VISION SYSTEMS GROUP, A DIVISION O510(k) NO: K101810(ABBREVIATED)
ATTN: CHRISTINE E NICHOLS RAC PHONE NO : 508 336 3668 134 FLANDERS RD. SE DECISION MADE: 30-AUG-10 WESTBOROUGH MA 01581 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CYBERWAND LITHOTRIPTER CYBERSONICS, INC. 510(k) NO: K102169(SPECIAL)
ATTN: JEFF VAITEKUNAS PHONE NO : 814 898 4734 5368 KUHL RD. SE DECISION MADE: 30-AUG-10 ERIE PA 16510 4703 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUDIT MICROCV RF/CRP LINEARITY SET AALTO SCIENTIFIC LTD. 510(k) NO: K101226(TRADITIONAL)
ATTN: DESSI LYAKOV PHONE NO : 760 431 7922 1959 KELLOGG AVE. SE DECISION MADE: 31-AUG-10 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IQ 200 URINE ANALIZER BODY FLUIDS MODULE IRIS DIAGNOSTICS 510(k) NO: K091539(TRADITIONAL)
ATTN: WILLIAM M DOUGHERTY PHONE NO : 818 709 1244 9172 ETON AVE. SE DECISION MADE: 31-AUG-10 CHATSWORTH CA 91311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 1.5 TESLA 16- CHANNEL RECEIVE-ONLY PHASED- ARRAY HEAD COIL FOR SIEMANS MR MEDICAL SOLUTIONS LLC 510(k) NO: K093689(TRADITIONAL)
ATTN: FAHAD ALRADADY PHONE NO : 412 787 3454 310 VISTA PARK DRIVE SE DECISION MADE: 31-AUG-10 PITTSBURG PA 15205 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GELSCAN, MODEL 1206 SEBIA 510(k) NO: K100307(TRADITIONAL) ATTN: KAREN ANDERSON PHONE NO : 770 446 3707 1705 CORPORATE DRIVE SUITE 400 SE DECISION MADE: 31-AUG-10 NORCROSS GA 30093 510(k) STATEMENT DEVICE: FREQUENCER MODEL V2X DYMEDSO INC. 510(k) NO: K100749(TRADITIONAL)
ATTN: JEAN BIGONEY PHONE NO : 802 885 8026 127 MAIN ST. SE DECISION MADE: 31-AUG-10 SPRINGFIELD VT 05156 0826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FASTX STERNAL INTRAOSSEOUS DEVICE PYNG MEDICAL CORP. 510(k) NO: K100124(TRADITIONAL)
ATTN: MAYA BUTTERFIELD PHONE NO : 604 303 7964 1351 CRESTWOOD PLACE UNIT 7 SE DECISION MADE: 31-AUG-10 RICHMOND, BC CA V6V 2E9 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 INSTRUMED INTERNATIONAL, INC. 510(k) NO: K100518(TRADITIONAL)
ATTN: MICHAEL MASSONG PHONE NO : 847 908 0292 626 COOPER COURT SE DECISION MADE: 31-AUG-10 SCHAUMBURG IL 60173 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K101600(ABBREVIATED)
ATTN: MARKUS STACHA PHONE NO : 497 031 4632842 HEWLETT-PACKARD STR.2 SE DECISION MADE: 31-AUG-10 BOEBLINGEN GM D 71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXPEDIUM SPINE SYSTEM MEDOS INTERNATIONAL SARL 510(k) NO: K101070(TRADITIONAL)
ATTN: DAPHNEY GERMAIN PHONE NO : 508 880 8395 325 PARAMOUNT DRIVE SE DECISION MADE: 31-AUG-10 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MYLABONE ULTRASOUND SYSTEM ESAOTE EUROPE B.V. 510(k) NO: K101605(TRADITIONAL)
ATTN: ALLISON SCOTT PHONE NO : 317 569 9500 11460 N. MERIDIAN STREET SUITE 150SE DECISION MADE: 31-AUG-10 CARMEL IN 46032 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NOBELPROCERA TI ABUTMENT THOMMEN PLATFORMS NOBEL BIOCARE AB 510(k) NO: K101714(SPECIAL)
ATTN: HERBERT CRANE PHONE NO : 714 282 4800 22715 SAVI RANCH PKWY. SE DECISION MADE: 31-AUG-10 YORBA LINDA CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCHER SUPER STIFF GUIDEWIRES MEDTRONIC INC. 510(k) NO: K101339(TRADITIONAL)
ATTN: COLLEEN MULLINS PHONE NO : 978 739 3267 3576 UNOCAL PLACE SE DECISION MADE: 31-AUG-10 SANTA ROSA CA 95403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TENS STIMULATOR, MODELS 2800 AND 3000 KOALATY PRODUCTS, INC. 510(k) NO: K102014(TRADITIONAL)
ATTN: KANG JIANG PING PHONE NO : 86 755 27652471 # 3 BLDG, XILIYANGGUANG IND ES XILSE DECISION MADE: 31-AUG-10 SHENZHEN, GUANGDONG CH 518108 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ELECSYS DIGOXIN CALCHECK 5 ROCHE DIAGNOSTICS 510(k) NO: K102044(TRADITIONAL)
ATTN: KELLY COLLEEN O'MAINE ADAMSPHONE NO : 317 521 3577 9115 HAGUE ROAD PO BOX 50416 SE DECISION MADE: 31-AUG-10 INDIANAPOLIS IN 46250 0416 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-930 ANDON HEALTH CO.,LTD 510(k) NO: K101950(SPECIAL)
ATTN: LIU YI PHONE NO : 862 260 526161 NO 3, JINPING STREET YA AN RD NANSE DECISION MADE: 31-AUG-10 TIANJIN CH 300190 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MR RADIATION ONCOLOGY OPTIONS GE MEDICAL SYSTEMS, LLC 510(k) NO: K102155(SPECIAL)
ATTN: TRACEY FOX PHONE NO : 262 521 6467 3200 N. GRANDVIEW BLVD. SE DECISION MADE: 31-AUG-10 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE LOGIQ P5 MODEL H44662LD GE HEALTHCARE 510(k) NO: K101878(SPECIAL)
ATTN: BRYAN BEHN PHONE NO : 414 721 4214 9900 INNOVATION DRIVE SE DECISION MADE: 31-AUG-10 WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CS-SERIES-FP OMEGA MEDICAL IMAGING, INC. 510(k) NO: K100102(TRADITIONAL)
ATTN: JAMES PRINCEHORN PHONE NO : 407 323 9400 675 HICKMAN CIRCLE SE DECISION MADE: 31-AUG-10 SANFORD FL 32771 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 241 TOTAL WITH SUMMARIES 221 TOTAL WITH STATEMENTS 20
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