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Medical Devices
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May 2009 510(k) Clearances
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD May 2009 DEVICE: BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM I2S MICRO IMPLANTABLE SYSTEMS, LLC510(k) NO: K090957(ABBREVIATED) ATTN: GARY SYRING PHONE NO : 608 877 2635 800 LEVANGER LANE SE DECISION MADE: 28-MAY-09 STOUGHTON WI 53589 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIVID, MODELS 40-A0001, 40-A0004, 40-A0006 PROGENY, INC. 510(k) NO: K090079(TRADITIONAL) ATTN: ALAN KREMA PHONE NO : 847 415 9800 675 HEATHROW DRIVE SE DECISION MADE: 01-MAY-09 LINCOLNSHIRE IL 60069 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HS II SHORT FIXTURE SYSTEM OSSTEM IMPLANT CO.,LTD 510(k) NO: K083633(TRADITIONAL) ATTN: MINJOO KIM PHONE NO : 888 678 0001 85 BEN FAIRLESS DR. SE DECISION MADE: 01-MAY-09 FAIRLESS HILLS PA 19030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND 190-5092-150SA AND SYRINGE ADAPTER ACCESSORY MICRO THERAPEUTICS, INC. 510(k) NO: K090870(SPECIAL) ATTN: TOM DAUGHTERS PHONE NO : 949 231 7780 9775 TOLEDO WAY SE DECISION MADE: 01-MAY-09 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150 EV3 INC. 510(k) NO: K090849(SPECIAL) ATTN: SARA BAKKAR PHONE NO : 763 398 7344 9600 54TH AVE NORTH SE DECISION MADE: 01-MAY-09 PLYMOUTH MN 55442 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND GE MEDICAL SYSTEMS CHINA CO., LTD.510(k) NO: K091374(TRADITIONAL) ATTN: YALAN WU PHONE NO : 865 108 5278652 NO. 19 CHANGJIANG ROAD NATIONAL HISE DECISION MADE: 26-MAY-09 WUXI, JIANGSU PROVINCE CH 21402510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: WU'S 3 WHEELED ELECTRICAL SCOOTER, WT-T3H WU'S TECH CO., LTD. 510(k) NO: K091212(TRADITIONAL) ATTN: JEN KE-MIN PHONE NO : 886 352 08829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 27-MAY-09 NSIN-CHU CITY TW 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JOURNEY (OR RPSP), JOURNEY CUBIC (OR SUPRA OR TP02) THYSSENKRUPP CETECO SRL 510(k) NO: K090856(TRADITIONAL) ATTN: FEDELE FABRIZIO PHONE NO : 39 050 955111 VIA S.CANNIZZARO, 2 SE DECISION MADE: 27-MAY-09 PISA IT 56121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACTIVAPATCH ACTIVATEK INC. 510(k) NO: K091326(TRADITIONAL) ATTN: JAMAL YANAKI PHONE NO : 801 969 0883 2734 S. 3600 WEST UNIT F SE DECISION MADE: 27-MAY-09 WEST VALLEY UT 84120 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO. 510(k) NO: K090827(TRADITIONAL) ATTN: SABA MODJARRAD PHONE NO : 410 316 4260 7 LOVETON CIR. SE DECISION MADE: 27-MAY-09 SPARKS MD 21152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADCALC SOFTWARE, VERSION 6.0 LIFELINE SOFTWARE, INC. 510(k) NO: K090531(TRADITIONAL) ATTN: RICHARD VINCINS PHONE NO : 512 327 9997 1705 S. CAPITAL OF TEXAS HWY. SUITSE DECISION MADE: 27-MAY-09 AUSTIN TX 78746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511 PHILIPS MEDICAL SYSTEMS(CLEVELAND)510(k) NO: K091195(TRADITIONAL) ATTN: MICHAEL CHILBERT PHONE NO : 440 483 3284 595 MINER RD. SE DECISION MADE: 27-MAY-09 CLEVELAND OH 44143 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NEUROMETRIX BIOAMPLIFIER NEUROMETRIX, INC. 510(k) NO: K083322(TRADITIONAL) ATTN: RAINER MAAS PHONE NO : 781 890 9989 62 FOURTH AVE. SE DECISION MADE: 27-MAY-09 WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER ALCAVIS INTERNATIONAL, INC. 510(k) NO: K082858(TRADITIONAL) ATTN: GARY J MISHKIN PHONE NO : 301 330 7597 8322 HELGERMAN COURT SE DECISION MADE: 27-MAY-09 GAITHERSBURG MD 20877 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1 INTRA-LOCK INTERNATIONAL, INC. 510(k) NO: K082419(ABBREVIATED) ATTN: JEFFREY SAKOFF PHONE NO : 561 447 8282 6560 W. ROGERS CIRCLE SUITE 24 SE DECISION MADE: 27-MAY-09 BOCA RATON FL 33487 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESTEP DVY SYSTEM, MODEL RSP-101 STORTFORD MEDICAL LLC 510(k) NO: K090308(TRADITIONAL) ATTN: CHRIS DAUGHTERY PHONE NO : 609 235 9292 295 PRINCETON HIGHTSTOWN ROAD UNITSE DECISION MADE: 01-MAY-09 WEST WINDSOR NJ 08550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM ACCURAY, INC. 510(k) NO: K091146(SPECIAL) ATTN: ANNE SCHLAGENHAFT PHONE NO : 408 716 4628 1310 ORLEANS DRIVE SE DECISION MADE: 01-MAY-09 SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES) TERUMO CORP. 510(k) NO: K090973(SPECIAL) ATTN: LYNNE WITKOWSKI PHONE NO : 410 392 7241 125 BLUE BALL RD. SE DECISION MADE: 01-MAY-09 ELKTON MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR V-PRO 1 STERILIZATION SYSTEM STERIS CORPORATION 510(k) NO: K090371(SPECIAL) ATTN: JOHN ROBERT SCOVILLE, JR. PHONE NO : 440 392 7330 5960 HEISLEY RD. SE DECISION MADE: 01-MAY-09 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30 GENZYME DIAGNOSTICS P.E.I. INC. 510(k) NO: K081938(TRADITIONAL) ATTN: PENNY J WHITE PHONE NO : 902 566 1396 700 WATTS AVENUE SE DECISION MADE: 01-MAY-09 CHARLOTTETOWN, PRIN ED ISLAND C510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLUCODR AUTO SYSTEM ALL MEDICUS CO., LTD 510(k) NO: K083628(TRADITIONAL) ATTN: MARGARET KIM PHONE NO : 82 31 4258288 7068 DONG-IL TECHNO TOWN 7TH 823 GSE DECISION MADE: 01-MAY-09 ANYANG, GYEONGGI-DO KS 431-062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS ELEKTA INSTRUMENT AB 510(k) NO: K080355(TRADITIONAL) ATTN: PETER LOWENDAHL PHONE NO : 011 468 58725400 KUNGSTENSGATAN 18 P.O.BOX 7593 SE DECISION MADE: 01-MAY-09 STOCKHOLM SW S-103 93 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONTERIS MEDICAL AUTOLITT LASER PROBE MONTERIS MEDICAL 510(k) NO: K081509(TRADITIONAL) ATTN: CRAIG COOMBS PHONE NO : 650 380 2474 1193 SHERMAN STREET SE DECISION MADE: 01-MAY-09 ALAMEDA CA 94501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BCI WW1030 PULSE OXIMETER SMITHS MEDICAL PM, INC. 510(k) NO: K083557(TRADITIONAL) ATTN: DONALD ALEXANDER PHONE NO : 262 650 2984 N7 W22025 JOHNSON DR. SE DECISION MADE: 01-MAY-09 WAUKESHA WI 53186 1856 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OEC 9900 ELITE GE HEALTHCARE SURGERY 510(k) NO: K082781(TRADITIONAL) ATTN: MARIA C FRAME PHONE NO : 801 517 6440 384 WRIGHT BROTHERS DRIVE SE DECISION MADE: 01-MAY-09 SALT LAKE CITY UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST NANOSPHERE, INC 510(k) NO: K083088(TRADITIONAL) ATTN: GREGORY W SHIPP PHONE NO : 847 400 9115 4088 COMMERCIAL AVENUE SE DECISION MADE: 01-MAY-09 NORTHBROOK IL 60062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM V 1.0 SMITH & NEPHEW, INC. 510(k) NO: K090420(ABBREVIATED) ATTN: SUSAN BELL PHONE NO : 901 399 5412 1450 BROOKS RD. SE DECISION MADE: 27-MAY-09 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XYLOS POROUS SURGICAL MESH XYLOS CORPORATION 510(k) NO: K090880(SPECIAL) ATTN: JOYCE ELKINS PHONE NO : 215 867 0220 838 TOWN CENTER DR. SE DECISION MADE: 27-MAY-09 LANGHORNE PA 19047 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXIPLAN 3D AND 3D+ ISODOSE CONTROL B.V. 510(k) NO: K091145(SPECIAL) ATTN: HUB VAN DE BERGH PHONE NO : 31 318 502950 MAXWELLSTRAAT 16 SE DECISION MADE: 27-MAY-09 EDE NL 6716 BX 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RIC CONFORMAL SOURCE, MODEL 100 RI CONSULTANTS, LLC 510(k) NO: K090321(TRADITIONAL) ATTN: THOMAS GOLEMBESKI PHONE NO : 603 247 1423 1 CHAGNON LANE SE DECISION MADE: 27-MAY-09 HUDSON NH 03051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210 BECKMAN COULTER, INC. 510(k) NO: K090588(TRADITIONAL) ATTN: MARY B TANG PHONE NO : 714 961 3777 200 SOUTH KRAEMER BLVD. SE DECISION MADE: 27-MAY-09 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABT GLUCOSE CONTROL SOLUTION, MODEL: 2120089 AMERICAN BIOLOGICAL TECHNOLOGIES, 510(k) NO: K090943(TRADITIONAL) ATTN: JOHN GORMLEY PHONE NO : 830 372 1391 940 CROSSROADS BLVD. SE DECISION MADE: 27-MAY-09 SEGUIN TX 78155 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 506CN PATIENT MONITOR CRITICARE SYSTEMS, INC. 510(k) NO: K091050(SPECIAL) ATTN: ALEX KAPLAN PHONE NO : 262 798 8282 20925 CROSSROADS CIRCLE SE DECISION MADE: 27-MAY-09 WAUKESHA WI 53186 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TXRX 1.5T CP HEAD COIL; TXRX 3T CP HEAD COIL QUALITY ELECTRODYNAMICS 510(k) NO: K091114(TRADITIONAL) ATTN: CHRISTIE ZYDYK PHONE NO : 440 484 2228 700 BETA DR. SUITE 100 SE DECISION MADE: 01-MAY-09 MAYFIELD VILLAGE OH 44143 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM HEMOSTATIX MEDICAL TECHNOLOGIES, L510(k) NO: K091107(TRADITIONAL) ATTN: JEFF COBB PHONE NO : 901 261 0012 8400 WOLF LAKE DR., STE. 109 SE DECISION MADE: 01-MAY-09 BARTLETT TN 38133 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: FLOWPICC CATHETER VASONOVA INC. 510(k) NO: K083920(TRADITIONAL) ATTN: KIM TOMPKINS PHONE NO : 408 738 7006 1368 BORDEAUX DR., SUITE 100 SE DECISION MADE: 01-MAY-09 SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: METATARSAL DECOMPRESSION IMPLANT, MODEL 100 SOLANA SURGICAL LLC 510(k) NO: K090127(TRADITIONAL) ATTN: BRUCE LAWRENCE PHONE NO : 760 757 3070 1828 BAILEY DRIVE SE DECISION MADE: 01-MAY-09 OCEANSIDE CA 92056 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORTEX TUOHY EPIDURAL NEEDLE 17G, PORTEX TUOHY EPIDURAL NEEDLE 18G SMITHS MEDICAL ASD, INC. 510(k) NO: K090261(TRADITIONAL) ATTN: CINDY ENGELHARDT PHONE NO : 603 352 3812 10 BOWMAN DR. SE DECISION MADE: 01-MAY-09 KEENE NH 03431 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500 AND KC600 KIMBERLY-CLARK CORP. 510(k) NO: K082554(TRADITIONAL) ATTN: LISA PEACOCK PHONE NO : 706 216 3413 172 CONDUCTOR DRIVE SE DECISION MADE: 01-MAY-09 DAWSONVILLE GA 30534 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CROSS-PILOT TURBO ELITE SUPPORT CATHETER SPECTRANETICS CORP. 510(k) NO: K090913(TRADITIONAL) ATTN: BRANDON HANSEN PHONE NO : 719 447 2385 9965 FEDERAL DRIVE SE DECISION MADE: 04-MAY-09 COLORADO SPRINGS CO 80921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY SYSTEM ALEXANDRIA RESEARCH TECHNOLOGIES, 510(k) NO: K090024(TRADITIONAL) ATTN: MICHAEL RENNER PHONE NO : 952 949 2235 13755 FIRST AVENUE NORTH SUITE 100SE DECISION MADE: 04-MAY-09 PLYMOUTH MN 55441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ISOLYSER HOME SHARPS MANAGEMENT (HSM), MODEL 800M; ISOLY SHARPS MANAGEMENT SYSTEM (SMS), MODELS 2400M, 4000M, 10000M, 5. WCM WASTE & COMPLIANCE MANAGEMENT,510(k) NO: K090157(TRADITIONAL) ATTN: SARA BETH WATSON PHONE NO : 202 429 6460 1330 CONNECTICUT AVE., NW SE DECISION MADE: 04-MAY-09 WASHINGTON DC 20036 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE SPINAL USA 510(k) NO: K083118(TRADITIONAL) ATTN: JEFFREY JOHNSON PHONE NO : 601 420 4244 2050 EXECUTIVE DR. SE DECISION MADE: 27-MAY-09 PEARL MS 39208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHODONTIC CERAMIC BRACKET STAR DENTECH KOREA., CORP 510(k) NO: K090567(TRADITIONAL) ATTN: BRANDON CHOI PHONE NO : 714 523 1592 49 CANDLEWOOD WAY SE DECISION MADE: 27-MAY-09 BUENA PARK CA 90621 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEXIS SENSOR DEXIS LLC 510(k) NO: K090458(TRADITIONAL) ATTN: CLAUDIA ORTIZ PHONE NO : 714 516 7981 1717 WEST COLLINS SE DECISION MADE: 28-MAY-09 ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS ROSTAM LTD. 510(k) NO: K090071(TRADITIONAL) ATTN: ROBERT J STAAB PHONE NO : 860 434 5872 30 NECK ROAD SE DECISION MADE: 28-MAY-09 OLD LYME CT 06371 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMUNOCARD STAT CAMPY, MODEL 751530 MERIDIAN BIOSCIENCE, INC. 510(k) NO: K090700(TRADITIONAL) ATTN: SUSAN D ROLIH PHONE NO : 513 271 3700 3471 RIVER HILLS DR. SE DECISION MADE: 28-MAY-09 CINCINNATI OH 45244 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS CARDIODYNAMICS INTERNATIONAL CORP.510(k) NO: K090602(TRADITIONAL) ATTN: DON BROOKS PHONE NO : 858 535 0202 6175 NANCY RIDGE DR., #300 SE DECISION MADE: 28-MAY-09 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERCUCATH URINARY CATHETER PERCUVISION LLC 510(k) NO: K090262(TRADITIONAL) ATTN: ERROL SINGH PHONE NO : 614 337 8700 765 NORTH HAMILTON RD. SUITE 260A SE DECISION MADE: 28-MAY-09 GAHANNA OH 43230 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5 SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K081769(TRADITIONAL) ATTN: RADAMES RIESGO PHONE NO : 305 480 7558 500 GBC DRIVE M/S 514 SE DECISION MADE: 28-MAY-09 NEWARK DE 19702 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01 PHADIA US INC. 510(k) NO: K083117(TRADITIONAL) ATTN: MARTIN ROBERT MANN PHONE NO : 269 492 1957 4169 COMMERCIAL AVE. SE DECISION MADE: 28-MAY-09 PORTAGE MI 49002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES ENCISION, INC. 510(k) NO: K090979(TRADITIONAL) ATTN: JUDITH V KING PHONE NO : 303 444 2600 6797 WINCHESTER CIR. SE DECISION MADE: 28-MAY-09 BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM, DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM CATHETER REPAIR KIT C.R. BARD, INC. 510(k) NO: K090528(TRADITIONAL) ATTN: JI HYUN KIM PHONE NO : 801 522 5000 605 N 5600 W SE DECISION MADE: 28-MAY-09 SALT LAKE CITY UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECSCOPE 100 DYANSYS, INC. 510(k) NO: K091358(TRADITIONAL) ATTN: SRINI NAGESHWAR PHONE NO : 650 579 7100 577 AIRPORT BLVD. SE DECISION MADE: 28-MAY-09 BURLINGAME CA 95032 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: HEMORPEX SYSTEM ANGIOLOGICA B. M. SRL 510(k) NO: K090432(TRADITIONAL) ATTN: ROBERTO MANCO PHONE NO : 390 382 556616 4, VIA GIOVANNI XXIII SE DECISION MADE: 29-MAY-09 SAN MARTINO SICCOMARIO, PAVIA I510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHILIPS M3001A MULTI MEASUREMENT SERVER PHILIPS MEDIZIN SYSTEME BOBLINGEN 510(k) NO: K090360(SPECIAL) ATTN: JENS-PETER SEHER PHONE NO : 49 703 14632086 HEWLETT-PACKARD-STR. 2 SE DECISION MADE: 04-MAY-09 BOBLINGEN GM D-71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE WITH HIGH STRENGTH SUTURE SURGICAL DEVICES, A GLOBAL BUSINES510(k) NO: K091016(SPECIAL) ATTN: TIM M LOHNES PHONE NO : 203 492 5462 60 MIDDLETOWN AVE SE DECISION MADE: 04-MAY-09 NORTH HAVEN CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODULE INTEGRATED RADIOTHERAPY SYSTEM (MIRS) NUCLEMED S.A. 510(k) NO: K090182(TRADITIONAL) ATTN: RAYMOND KELLY PHONE NO : 603 595 0095 56B SHADOWBROOK DR. SE DECISION MADE: 04-MAY-09 HUDSON NH 03051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUME 2 SYSTEM, MODEL GA0005000 LUMENIS, LTD. 510(k) NO: K083733(TRADITIONAL) ATTN: FRANCES HARRISON PHONE NO : 770 630 3281 3959 WEST 1820 SOUTH SE DECISION MADE: 04-MAY-09 SALT LAKE CITY UT 84104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONMED AER DEFENSE SMOKE EVACUATOR CONMED CORPORATION 510(k) NO: K091139(TRADITIONAL) ATTN: DEMARIS VELEZ PHONE NO : 303 699 7600 14603 E. FREMONT AVE. SE DECISION MADE: 05-MAY-09 CENTENNIAL CO 80112 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ELECSYS RUBELLA IGG CALCHECK ROCHE DIAGNOSTICS 510(k) NO: K090311(TRADITIONAL) ATTN: KELLY FRENCH PHONE NO : 317 521 3208 9115 HAGUE ROAD SE DECISION MADE: 05-MAY-09 INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PANTHER REALART, MODEL 4.7 PROWESS, INC. 510(k) NO: K083502(TRADITIONAL) ATTN: RACHEL SCARANO PHONE NO : 925 356 0360 5063 COMMERCIAL CIRCLE SUITE A&B SE DECISION MADE: 05-MAY-09 CONCORD CA 94520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000 CARL ZEISS MEDITEC INC 510(k) NO: K083291(TRADITIONAL) ATTN: JUDITH A BRIMACOMBE PHONE NO : 925 557 4616 5160 HACIENDA DR. SE DECISION MADE: 05-MAY-09 DUBLIN CA 94568 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM BRONCUS TECHNOLOGIES, INC. 510(k) NO: K091160(SPECIAL) ATTN: MAHTAB FATEMI PHONE NO : 650 428 1600 1400 N. SHORELINE BLVD. BLDG A SUISE DECISION MADE: 05-MAY-09 MOUNTAIN VEIW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GE VENUE 40, MODEL 5324338 GE MEDICAL SYSTEMS CHINA CO., LTD.510(k) NO: K091164(TRADITIONAL) ATTN: YALAN WU PHONE NO : 865 108 5278652 NO. 19 CHANGJIANG ROAD NATIONAL HISE DECISION MADE: 05-MAY-09 WUXI, JIANGSU PROVINCE CH 21402510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: THE CROSSER 14 OTW CATHETER, MODEL CRU014 FLOWCARDIA, INC. 510(k) NO: K091254(SPECIAL) ATTN: DUSTIN MICHAELS PHONE NO : 408 617 0352 745 N. PASTORIA AVE. SE DECISION MADE: 29-MAY-09 SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH TERUMO MEDICAL CORP. 510(k) NO: K091329(SPECIAL) ATTN: MARK UNTERREINER PHONE NO : 410 392 7213 950 ELKTON BLVD. SE DECISION MADE: 29-MAY-09 ELKTON MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TANTHERA-T35 TANTHERA, INC. 510(k) NO: K090831(TRADITIONAL) ATTN: NATHAN A BEAVER, ESQ PHONE NO : 202 295 4039 3000 K STREET NW SUITE 500 SE DECISION MADE: 29-MAY-09 WASHINGTON DC 20007 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL RADIOGRAPHY, MODEL CXDI-55C CANON, INC. 510(k) NO: K091436(TRADITIONAL) ATTN: SHEILA DRISCOLL PHONE NO : 516 328 5602 ONE CANON PLAZA SE DECISION MADE: 29-MAY-09 LAKE SUCCESS NY 11042 1198 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DIGITAL RADIOGRAPHY MODEL CXDI-55G CANON INC. 510(k) NO: K091435(TRADITIONAL) ATTN: SHEILA DRISCOLL PHONE NO : 516 328 5602 ONE CANON PLAZA SE DECISION MADE: 29-MAY-09 LAKE SUCCESS NY 11042 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ISOFLOW INFUSION CATHETER VASCULAR DESIGNS INC. 510(k) NO: K081147(TRADITIONAL) ATTN: GRACE HOLLAND PHONE NO : 949 262 0411 3722 AVE. SAUSALITO SE DECISION MADE: 29-MAY-09 IRVINE CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SRI LEVEL II SURGICAL GOWN SRI SURGICAL 510(k) NO: K090383(ABBREVIATED) ATTN: NISSA MULNICK PHONE NO : 813 891 9550 12425 RACE TRACK RD. SE DECISION MADE: 29-MAY-09 TAMPA FL 33626 510(k) STATEMENT DEVICE: NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLOR, POLYMER COATED, TEXTED WITH CHEMOTHERAPY DRUGS SIAM SEMPERMED CORP. LTD. 510(k) NO: K082957(ABBREVIATED) ATTN: WILLIAM E HARRIS PHONE NO : 727 787 7250 13900 49TH STREET NORTH SE DECISION MADE: 29-MAY-09 CLEARWATER FL 33762 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K083598(TRADITIONAL) ATTN: CRYSTAL DIZOL PHONE NO : 310 338 8100 600 CORPORATE POINTE SE DECISION MADE: 29-MAY-09 CULVER CITY CA 90230 7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C JOHARI DIGITAL HEALTHCARE, LTD. 510(k) NO: K090052(TRADITIONAL) ATTN: NISHA JOHARI PHONE NO : 912 931 281531 ELECTRONIC HARDWARE TECHNOLOGY PARSE DECISION MADE: 29-MAY-09 BORANADA, JODHPUR, RAJASTHAN IN510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INCLUSIVE ZIRCONIA ABUTMENT BLANKS INCLUSIVE DENTAL SOLUTIONS 510(k) NO: K083480(ABBREVIATED) ATTN: KEITH D ALLRED PHONE NO : 949 440 2683 4141 MACARTHUR BLVD SE DECISION MADE: 05-MAY-09 NEWPORT BEACH CA 92660 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHADAPT PR PEGASUS BIOLOGICS, INC. 510(k) NO: K090288(TRADITIONAL) ATTN: AMY BOUCLY PHONE NO : 949 502 3240 6 JENNER SUITE 150 SE DECISION MADE: 05-MAY-09 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00 MICRUS ENDOVASCULAR CORPORATION 510(k) NO: K083922(SPECIAL) ATTN: PATRICK LEE PHONE NO : 408 433 1428 821 FOX LANE SE DECISION MADE: 06-MAY-09 SAN JOSE CA 95131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASTHMA MONITOR MODEL, AM1 CARDINAL HEALTH GERMANY 234 GMBH 510(k) NO: K090486(SPECIAL) ATTN: THOMAS GUTIERREZ PHONE NO : 760 778 7255 REGULATORY AFFAIRS 1100 BIRD CENTESE DECISION MADE: 06-MAY-09 PALM SPRINGS CA 92262 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HD GUIDE CATHETER CONCENTRIC MEDICAL, INC. 510(k) NO: K090335(SPECIAL) ATTN: LARAINE PANGELINA PHONE NO : 650 938 2100 301 E. EVELYN AVE. SE DECISION MADE: 06-MAY-09 MOUNTAIN VIEW CA 94041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIGAFIX INTERFACE SCREW SCIENCE FOR BIOMATERIALS 510(k) NO: K090994(SPECIAL) ATTN: DENIS CLEMENT PHONE NO : 33 5 62422101 ZI DU MONGE SE DECISION MADE: 06-MAY-09 LOURDES FR 65100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LASER TOUCHONE LASER HEALTH TECHNOLOGIES, LLC 510(k) NO: K083822(TRADITIONAL) ATTN: PATSY TRISLER PHONE NO : 301 652 5344 5600 WISCONSIN AVE., SUITE 509 SE DECISION MADE: 06-MAY-09 CHEVY CHASE MD 20815 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LARIAT II SUTURE DELIVERY DEVICE SENTREHEART INC. 510(k) NO: K090385(TRADITIONAL) ATTN: LINDA GUTHRIE PHONE NO : 650 354 1200 2468 EMBARCADERO WAY SE DECISION MADE: 06-MAY-09 PALO ALTO CA 94303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VONFLEX PUTTY VERICOM CO., LTD. 510(k) NO: K091267(TRADITIONAL) ATTN: MYUNG-HWAN OH PHONE NO : 82 31 4412881 #606,5TH DONGYOUNG VENTURESTEL 199SE DECISION MADE: 06-MAY-09 ANYANG-SI, GYEONGGI-DO KS 430-8510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MATCHEDFLICKER EYEIC CORPORATION 510(k) NO: K090266(TRADITIONAL) ATTN: MORRIS WAXLER PHONE NO : 608 219 7547 1920 ARLINGTON PLACE SE DECISION MADE: 06-MAY-09 MADISON WI 53726 4002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS GIMMI GMBH 510(k) NO: K081640(ABBREVIATED) ATTN: KEN BLAKE PHONE NO : 651 298 0997 ONE SCANLAN PLAZA SE DECISION MADE: 06-MAY-09 SAINT PAUL MN 55107 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PAINMASTER MCT PATCH NEWMARK, INC. 510(k) NO: K090042(TRADITIONAL) ATTN: DEBORAH LIVORNESE PHONE NO : 202 736 3622 919 EIGHTEENTH STREET NW SUITE 600SE DECISION MADE: 06-MAY-09 WASHINGTON DC 20006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CIRCULATOR BOOT CIRCULATOR BOOT CORP. 510(k) NO: K082134(TRADITIONAL) ATTN: RICHARD S DILLON PHONE NO : 72 PENNSYLVANIA AVE. SE DECISION MADE: 07-MAY-09 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HANSEN MEDICAL ARTISAN S CONTROL CATHETER HANSEN MEDICAL, INC. 510(k) NO: K090365(SPECIAL) ATTN: KATE WHITIN PHONE NO : 650 404 5800 800 E. MIDDLEFIELD ROAD SE DECISION MADE: 07-MAY-09 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAFEFLO VENA CAVA FILTER RMT MEDICAL TECHNILOGIES INC. 510(k) NO: K081138(TRADITIONAL) ATTN: JANICE M HOGAN PHONE NO : 267 675 4611 1835 MARKET STREET SUITE 200 SE DECISION MADE: 07-MAY-09 PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPEQ ULTRASOUND SYSTEM SIGNOSTICS PTY LTD 510(k) NO: K090505(TRADITIONAL) ATTN: CHARLES F HOTTINGER PHONE NO : 206 780 7945 13221 NE TEEM LOOP ROAD SE DECISION MADE: 07-MAY-09 BAINBRIDGE ISLAND WA 98110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) SHIJIAZHUANG BENESTAR PLASTIC CO.,510(k) NO: K090691(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 861 082 387441 ROOM 1606 BLDG, 1 JIANXIANG YUAN NSE DECISION MADE: 07-MAY-09 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC GENESEE BIOMEDICAL, INC. 510(k) NO: K090428(SPECIAL) ATTN: JOHN WRIGHT PHONE NO : 303 777 3000 1308 SOUTH JASON ST. SE DECISION MADE: 07-MAY-09 DENVER CO 80223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROCERA IMPLANT BRIDGE OVERDENTURE NOBEL BIOCARE AB 510(k) NO: K090069(TRADITIONAL) ATTN: HERBERT CRANE PHONE NO : 714 282 4800 22715 SAVI RANCH PKWY. SE DECISION MADE: 07-MAY-09 YORBA LINDA CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020 COLOPLAST A/S 510(k) NO: K091152(SPECIAL) ATTN: ANGELA BYLAND PHONE NO : 612 287 4236 HOLTEDAM 1 SE DECISION MADE: 07-MAY-09 HUMLEBAEK DA 3050 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL 350G GAS CONSERVER INSPIRED TECHNOLOGIES, INC. 510(k) NO: K090421(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DRIVE SE DECISION MADE: 29-MAY-09 BONITA SPRINGS FL 34134 2958 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESPIRONICS PERFORMAX TOTAL FACE MASK RESPIRONICS INC., SLEEP & HOME RES510(k) NO: K091271(SPECIAL) ATTN: ANDREW P ZELTWANGER PHONE NO : 724 387 7500 1001 MURRY RIDGE LN. SE DECISION MADE: 29-MAY-09 MURRYSVILLE PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXTT-101 APIMEDS, INC 510(k) NO: K082436(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720 962 5412 5401 S. COTTONWOOD CT SE DECISION MADE: 29-MAY-09 GREENWOOD VILLAGE CO 80121 510(k) STATEMENT DEVICE: PARIETEX MONOFILAMENT POLYESTER MESH SOFRADIM PRODUCTION 510(k) NO: K090858(TRADITIONAL) ATTN: ANGELA BUNN PHONE NO : 770 788 2610 60 MIDDLETOWN AVENUE SE DECISION MADE: 06-MAY-09 NORTH HAVEN CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTUITIVE SURGICAL ENDOWRIST ONE HOT SHEARS INSTRUMENT INTUITIVE SURGICAL, INC. 510(k) NO: K082497(TRADITIONAL) ATTN: JAMES FARNWORTH PHONE NO : 408 523 2100 950 KIFER RD. SE DECISION MADE: 07-MAY-09 SUNNYVALE CA 94086 5206 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC ELLMAN INT'L INC. 510(k) NO: K082834(TRADITIONAL) ATTN: RICK EPSTEIN PHONE NO : 516 267 6700 3333 ROYAL AVENUE SE DECISION MADE: 07-MAY-09 OCEANSIDE NY 11572 3625 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INNOPORT LAPAROSCOPIC ACCESS DEVICE INNOVIA LLC 510(k) NO: K090677(TRADITIONAL) ATTN: BRUCE WEBER PHONE NO : 305 378 2651 12415 S.W. 136TH AVE., UNIT 3 SE DECISION MADE: 07-MAY-09 MIAMI FL 33186 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOLOC 2.0/2.4 PLATE SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K090692(TRADITIONAL) ATTN: FRED W BOWMAN PHONE NO : 901 867 4143 5677 AIRLINE RD. SE DECISION MADE: 08-MAY-09 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCUTORR V MONITOR, MODEL 0998-00-2000 DATASCOPE CORP., PATIENT MONITORIN510(k) NO: K091068(SPECIAL) ATTN: KATHLEEN KRAMER PHONE NO : 201 995 8169 800 MACARTHUR BLVD. SE DECISION MADE: 08-MAY-09 MAHWAH NJ 07430 0619 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GRIND NO MORE VERSION 2 AND 3 RANIR LLC 510(k) NO: K091175(SPECIAL) ATTN: JONATHAN S KAHAN PHONE NO : 202 637 5794 555 THIRTEENTH STREET, NW SE DECISION MADE: 08-MAY-09 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM RESPIRONICS INC., SLEEP & HOME RES510(k) NO: K090243(SPECIAL) ATTN: ZITA A YURKO PHONE NO : 724 387 4120 1001 MURRY RIDGE LN. SE DECISION MADE: 08-MAY-09 MURRYSVILLE PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRANIAL IMAGE GUIDED SURGERY SYSTEM BRAINLAB AG 510(k) NO: K082060(TRADITIONAL) ATTN: RAINER BIRKENBACH PHONE NO : 49 899 915680 KAPELLENSTRASSE 12 SE DECISION MADE: 08-MAY-09 FELDKIRCHEN GM 85622 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM BIO-RAD LABORATORIES 510(k) NO: K090409(TRADITIONAL) ATTN: DAVID V BHEND PHONE NO : 425 498 1758 6565 185TH AVE, NE SE DECISION MADE: 08-MAY-09 REDMOND WA 98052 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEUROPET PHOTODETECTION SYSTEMS, INC. 510(k) NO: K091269(TRADITIONAL) ATTN: STEWART TUTTLE PHONE NO : 978 266 0420 85 SWANSON ROAD SE DECISION MADE: 08-MAY-09 BOXBOROUGH MA 01719 1300 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM MEDI-GLOBE CORPORATION 510(k) NO: K091257(TRADITIONAL) ATTN: SCOTT KARLER PHONE NO : 480 897 2772 110 WEST ORION ST #136 SE DECISION MADE: 08-MAY-09 TEMPE AZ 85283 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634 DAKO NORTH AMERICA, INC. 510(k) NO: K081286(TRADITIONAL) ATTN: KELLY MILLER PHONE NO : 805 566 6655 6392 VIA REAL SE DECISION MADE: 08-MAY-09 CARPINTERIA CA 93013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS COLOPLAST A/S 510(k) NO: K083499(TRADITIONAL) ATTN: JANELL A COLLEY PHONE NO : 612 287 4211 1499 WEST RIVER ROAD NORTH SE DECISION MADE: 08-MAY-09 MINNEAPOLIS MN 55411 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN ANIARA DIAGNOSTICA ,LLC 510(k) NO: K083729(TRADITIONAL) ATTN: OLA ANDERSON PHONE NO : 513 770 1979 6560 GOVE COURT SE DECISION MADE: 08-MAY-09 MASON OH 45040 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PELVIC FLOOR REPAIR SYSTEM BOSTONSCIENTIFIC 510(k) NO: K091131(ABBREVIATED) ATTN: MICHELLE BERRY PHONE NO : 508 683 4941 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 08-MAY-09 MARLBOROUGH MA 01760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM INTEGRA RADIONICS, INC. 510(k) NO: K090864(TRADITIONAL) ATTN: KEVIN J O'CONNELL PHONE NO : 781 565 1227 22 TERRY AVENUE SE DECISION MADE: 08-MAY-09 BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUVASIVE LATERAL PLATE SYSTEM NUVASIVE, INC. 510(k) NO: K091071(SPECIAL) ATTN: HAN FAN PHONE NO : 858 909 3338 7475 LUSK BLVD SE DECISION MADE: 08-MAY-09 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT IOP, INC. 510(k) NO: K090078(TRADITIONAL) ATTN: JASON MALECKA PHONE NO : 714 549 1185 3184-B AIRWAY AVE SE DECISION MADE: 08-MAY-09 COSTA MESA CA 92626 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE REPROCESSING PRODUCTS CORP. 510(k) NO: K090338(TRADITIONAL) ATTN: WALLY JANSEN PHONE NO : 763 420 4355 8662 COMSTOCK LN. SE DECISION MADE: 08-MAY-09 MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNGO RT THERAPIST CONNECT SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K090683(SPECIAL) ATTN: CHRISTINE DUNBAR PHONE NO : 925 602 8157 4040 NELSON AVE. SE DECISION MADE: 08-MAY-09 CONCORD CA 94520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PMT SUBDURAL CORTICAL ELECTRODES PMT CORP. 510(k) NO: K082474(TRADITIONAL) ATTN: ERIC CAILLE PHONE NO : 952 470 0866 1500 PARK RD. SE DECISION MADE: 08-MAY-09 CHANHASSEN MN 55317 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWER DRIVE CHAIR, MODEL: TMM6 TRANSMOTION MEDICAL INC. 510(k) NO: K091043(TRADITIONAL) ATTN: EDWARD A KROLL PHONE NO : 440 546 9810 5905 FAWN LN. SE DECISION MADE: 11-MAY-09 CLEVELAND OH 44124 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTI-CHANNEL LASER THERAPY (ACUPUNCTURE) SYSTEM, MODEL LA-400 UNITED INTEGRATED SERVICES CO., LT510(k) NO: K082686(TRADITIONAL) ATTN: DAVID O CHANG PHONE NO : 886 2 29170140 3 F., NO. 4, LANE 7 PAOKAO ROAD SE DECISION MADE: 11-MAY-09 HSINTIEN CITY, TAIPEI HSIEN TW 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOCKIT! AND MCMERLIN DERMAL WOUND GEL MCMERLIN DENTAL PRODUCTS LP 510(k) NO: K090092(TRADITIONAL) ATTN: AARON HENDERSHOTT PHONE NO : 972 602 3746 1610 WEST POLO RD. SE DECISION MADE: 11-MAY-09 GRAND PRAIRIE TX 75052 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: PSS SYSTEM SPINAL USA 510(k) NO: K090033(SPECIAL) ATTN: JEFFREY JOHNSON PHONE NO : 601 420 4244 2050 EXECUTIVE DR. SE DECISION MADE: 06-MAY-09 PEARL MS 39208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIRAGE ECHO RESMED CORP. 510(k) NO: K090490(TRADITIONAL) ATTN: DAVID D'CRUZ PHONE NO : 858 746 2238 14040 DANIELSON ST. SE DECISION MADE: 06-MAY-09 POWAY CA 92064 6857 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PULPDENT MICRO-HYBRID COMPOSITE PULPDENT CORPORATION 510(k) NO: K090391(TRADITIONAL) ATTN: KENNETH J BERK PHONE NO : 617 926 6666 80 OAKLAND ST. SE DECISION MADE: 11-MAY-09 WATERTOWN MA 02472 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FSC 2 SCHOELLY IMAGING, INC. 510(k) NO: K090601(TRADITIONAL) ATTN: F. DAVID ROTHKOPF PHONE NO : 508 231 8842 100 HARTWELL STREET SE DECISION MADE: 11-MAY-09 WEST BOYLSTON MA 01583 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAXIMA V, THREE WHEEL SCOOTER, MODEL SC900V MAXIMA V, FOUR WHEEL SCOOTER, MODEL SC940V PRIDE MOBILITY PRODUCTS CORP. 510(k) NO: K091113(SPECIAL) ATTN: THOMAS SCHAPPERT PHONE NO : 570 655 5574 182 SUSQUEHANNA AVE. SE DECISION MADE: 11-MAY-09 EXETER PA 18643 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-100, 9-TV45X45-10F-100 AGA MEDICAL CORP. 510(k) NO: K083214(SPECIAL) ATTN: DIANE CARROLL PHONE NO : 763 531 3161 5050 NATHAN LANE NORTH SE DECISION MADE: 12-MAY-09 PLYMOUTH MN 55442 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEGMENT MEDVISO 510(k) NO: K090833(TRADITIONAL) ATTN: EINAR HEIBERG PHONE NO : 46 761 836442 THULEHEMSVAGEN 157 SE DECISION MADE: 12-MAY-09 LUND SW SE-22467 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NMI PICC NAVILYST MEDICAL, INC. 510(k) NO: K091261(SPECIAL) ATTN: NICHOLAS CONDAKES PHONE NO : 508 658 7931 26 FOREST STREET SE DECISION MADE: 12-MAY-09 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAMINOPLASTY PLATING SYSTEM AESCULAP IMPLANT SYSTEM, INC. 510(k) NO: K090354(TRADITIONAL) ATTN: LISA M BOYLE PHONE NO : 610 984 9274 3773 CORPORATE PARKWAY SE DECISION MADE: 12-MAY-09 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REFINE LIFT SYSTEM ALURE MEDICAL INC. 510(k) NO: K083102(TRADITIONAL) ATTN: JASPER BENKE PHONE NO : 760 585 1570 2445 IMPALA DR. SE DECISION MADE: 11-MAY-09 CARLSBAD CA 92010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRONO S-PID 50 CRANE S.P.A. 510(k) NO: K091042(SPECIAL) ATTN: CARLO MUSSO PHONE NO : 39 011 9574872 VIA PAVIA, 105/I 10090 SE DECISION MADE: 12-MAY-09 RIVOLI-CASCINE VICA (TORINO) IT510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCALEMAN BODY FAT SCALES, MODEL: FS-148BW1 SERIES FOOK TIN TECHNOLOGIES LIMITED 510(k) NO: K083838(TRADITIONAL) ATTN: JOHN CHAI PHONE NO : 852 296 07288 4/F., EASTERN CENTRE 1065 KING'S RSE DECISION MADE: 12-MAY-09 QUARRY BAY HK 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IRIDVI-1 MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K091040(TRADITIONAL) ATTN: SUSAN GOLDSTEIN-FALK PHONE NO : MDI CONSULTANTS, INC. 55 NORTHERN SE DECISION MADE: 13-MAY-09 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM ST. JUDE MEDICAL 510(k) NO: K081803(TRADITIONAL) ATTN: ANDREA HUDACK PHONE NO : 952 351 1627 14901 DEVEAU PL. SE DECISION MADE: 13-MAY-09 MINNETONKA MN 55345 2126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORA G30 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241 TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K090187(TRADITIONAL) ATTN: YUHUA CHEN PHONE NO : 886 2 66258188 6F, NO. 127, WUGONG 2ND RD WUGU TOSE DECISION MADE: 12-MAY-09 TAIPEI COUNTY TW 241 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026 KCI USA, INC. 510(k) NO: K090489(SPECIAL) ATTN: CHRISTY H OVIATT PHONE NO : 210 255 6105 6203 FARINON DR. SE DECISION MADE: 14-MAY-09 SAN ANTONIO TX 78249 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES COVIDIEN 510(k) NO: K090470(TRADITIONAL) ATTN: JENNIFER BRENNAN PHONE NO : 203 492 5346 60 MIDDLETWON DR SE DECISION MADE: 14-MAY-09 NORTH HAVEN CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AONGEN COLLAGEN MATRIX AEON ASTRON EUROPE B.V. 510(k) NO: K080868(TRADITIONAL) ATTN: HORNG J LAI PHONE NO : 31 713 322280 NIELS BOHRWEG 11-13 SE DECISION MADE: 14-MAY-09 LEIDEN NL 2333 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL EFRATGO, LTD. HI TECH BIO-SURGICAL510(k) NO: K083648(TRADITIONAL) ATTN: GEORGE J HATTUB PHONE NO : 508 479 6116 291 HILLSIDE AVE. SE DECISION MADE: 14-MAY-09 SOMERSET MA 02726 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DVX SPINE SYSTEM BK MEDITECH CO., LTD. 510(k) NO: K090424(TRADITIONAL) ATTN: ELAINE DUNCAN PHONE NO : 715 549 6035 PO BOX 560 SE DECISION MADE: 14-MAY-09 STILLWATER MN 55082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER BRIDGEPOINT MEDICAL 510(k) NO: K081130(TRADITIONAL) ATTN: MICHAEL A DANIEL PHONE NO : 415 407 0223 8 SNOWBERRY COURT SE DECISION MADE: 14-MAY-09 ORINDA CA 94563 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC BAYER HEALTHCARE, LLC 510(k) NO: K090413(SPECIAL) ATTN: CATHY PETERS PHONE NO : 408 524 2255 510 OAKMEAD PKWY. SE DECISION MADE: 14-MAY-09 SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEARLAB OSMOLARITY SYSTEM OCUSENSE, INC. 510(k) NO: K083184(TRADITIONAL) ATTN: JANICE M HOGAN PHONE NO : 267 675 4611 1835 MARKET ST., 29TH FLOOR SE DECISION MADE: 14-MAY-09 PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITAL SIGNS MONITOR EDAN INSTRUMENTS, INC. 510(k) NO: K083821(TRADITIONAL) ATTN: WILLIAM STERN PHONE NO : 914 376 5200 1 ODELL PLAZA SE DECISION MADE: 14-MAY-09 YONKERS NY 10701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BREAS VIVO 40 SYSTEM BREAS MEDICAL AB 510(k) NO: K090113(TRADITIONAL) ATTN: BIRGITTA BOLANDER PHONE NO : 463 186 8830 FORETAGSVAGEN 1 SE DECISION MADE: 14-MAY-09 MOLNLYCKE SW 435 33 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING CORRECTIONS ULTRASPECT LTD. 510(k) NO: K091073(SPECIAL) ATTN: DAN LAOR PHONE NO : 972 4 8246632 6 SIRENI SE DECISION MADE: 14-MAY-09 HAIFA IS 32972 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0 TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K091295(TRADITIONAL) ATTN: PAUL BIGGINS PHONE NO : 714 730 5000 2441 MICHELLE DR. P.O. BOX 2068 SE DECISION MADE: 15-MAY-09 TUSTIN CA 92781 2068 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K090390(SPECIAL) ATTN: MELISA LANSKY PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 15-MAY-09 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO THE CROSSER SYSTEM FLOWCARDIA, INC. 510(k) NO: K091119(SPECIAL) ATTN: DUSTIN MICHAELS PHONE NO : 408 617 0352 745 N. PASTORIA AVE. SE DECISION MADE: 15-MAY-09 SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEUCODIA VERISCI CORPORATION 510(k) NO: K081591(TRADITIONAL) ATTN: GEORGE HU PHONE NO : 908 725 5213 106 ANDERSON STREET SE DECISION MADE: 15-MAY-09 RARITAN NJ 08869 1514 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022 INVIRO MEDICAL DEVICES, INC. 510(k) NO: K083851(SPECIAL) ATTN: JIM BARLEY PHONE NO : 678 405 4031 1755 NORTH BROWN ROAD SUITE 150 SE DECISION MADE: 15-MAY-09 LAWRENCEVILLE GA 30043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIEHM VISION RFD ZIEHM IMAGING, INC. 510(k) NO: K083545(TRADITIONAL) ATTN: RICHARD WESTRICH PHONE NO : 951 781 2020 4181 LATHAM ST. SE DECISION MADE: 15-MAY-09 RIVERSIDE CA 92501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EPICARDIA 5000 MEDICOMP, INC. 510(k) NO: K090834(SPECIAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949 429 5825 55 NORTHERN BLVD. SUITE 200 SE DECISION MADE: 15-MAY-09 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECTRA SYSTEM DENTAL IMPLANTS 2008 IMPLANT DIRECT LLC 510(k) NO: K090234(TRADITIONAL) ATTN: THOMAS GOTTENBOS PHONE NO : 818 444 3317 27030 MALIBU HILLS RD. SE DECISION MADE: 15-MAY-09 CALABASAS HILLS CA 91301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNGO US WORKPLACE SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K091286(TRADITIONAL) ATTN: SHELLY PEARCE PHONE NO : 650 694 5988 1230 SHOREBIRD WAY SE DECISION MADE: 15-MAY-09 MOUNTAIN VIEW CA 94039 7393 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BACKSTOP CATHETER, MODEL 60-0000-3100 PLUROMED, INC. 510(k) NO: K090270(ABBREVIATED) ATTN: JAMES WILKIE PHONE NO : 781 932 0574 25-H OLYMPIA AVENUE SE DECISION MADE: 15-MAY-09 WOBURN MA 01801 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V SCICAN LTD. 510(k) NO: K090265(ABBREVIATED) ATTN: BRENDA MURPHY PHONE NO : 416 446 2797 1440 DON MILLS RD. SE DECISION MADE: 15-MAY-09 TORONTO, ONTARIO CA M3B 3P9 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESPIRONICS SLEEPEASY CPAP SYSTEM RESPIRONICS, INC. 510(k) NO: K091112(SPECIAL) ATTN: ZITA A YURKO PHONE NO : 724 387 4120 1740 GOLDEN MILE HIGHWAY SE DECISION MADE: 15-MAY-09 MONROEVILLE PA 15146 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOTUS II PULSED ER: YAG LASER SYSTEM LASEROPTEK CO. LTD. 510(k) NO: K083253(TRADITIONAL) ATTN: PHILLIP CHEON PHONE NO : 800 580 0789 22750 HAWTHORNE BLVD. SUITE 211 SE DECISION MADE: 15-MAY-09 TORRANCE CA 90505 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OF GLOVE WEAR SAFE (MALAYSIA) SDN. BHD. 510(k) NO: K090066(TRADITIONAL) ATTN: S.H. TAM PHONE NO : 603 329 12657 LOT PT 13726,JALAN HAJI SALLEH OFFSE DECISION MADE: 15-MAY-09 KLANG, SELANGOR MY 41050 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT GISH BIOMEDICAL, INC. 510(k) NO: K082403(TRADITIONAL) ATTN: HARVEY KNAUSS PHONE NO : 713 723 4080 11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 15-MAY-09 HOUSTON TX 77071 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WV1417A DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM DIRECT DIGITAL IMAGING TECHNOLOGY 510(k) NO: K090062(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 862 164 264467 SUITE 8D, NO.19, LANE 999 ZHONGSHASE DECISION MADE: 18-MAY-09 SHANGHAI CH 200030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191 VILLA SISTEMI MEDICALI S.P.A. 510(k) NO: K090749(ABBREVIATED) ATTN: PAOLO C SANTIN PHONE NO : 390 248 8591 VIA DELLE AZALEE 3 SE DECISION MADE: 18-MAY-09 BUCCINASCO IT 20090 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL TRANSOMA MEDICAL 510(k) NO: K091206(SPECIAL) ATTN: LISA STONE PHONE NO : 651 414 5521 4211 LEXINGTON AVE., NORTH SUITE #SE DECISION MADE: 18-MAY-09 ST. PAUL MN 55126 6164 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE, MODEL ZLK-100 MEDI-KHAN USA, INC 510(k) NO: K083455(TRADITIONAL) ATTN: JULIE SANTIAGO PHONE NO : 510 864 0463 1516 OAK STREET, SUITE 312 SE DECISION MADE: 18-MAY-09 ALAMEDA CA 94501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL RING CT/MR APPLICATOR SET,MODEL 110.330, NUCLETRON CORPORATION 510(k) NO: K091154(SPECIAL) ATTN: ELAINA COLBY PHONE NO : 443 545 2164 8671 ROBERT FULTON DR. SE DECISION MADE: 18-MAY-09 COLUMBIA MD 21046 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNGOCIRCULATION DYNAMICPET, VERSION 1.0 SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K083327(TRADITIONAL) ATTN: GUNHILD PAULSEN PHONE NO : 847 304 7516 2501 NORTH BARRINGTON RD. SE DECISION MADE: 18-MAY-09 HOFFMAN ESTATES IL 60192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASTERSCREEN PAED - BABY BODY VIASYS HEALTHCARE GMBH 510(k) NO: K081823(TRADITIONAL) ATTN: THOMAS RUST PHONE NO : 49 931 4972383 LEIBNIZSTRASSE 7 SE DECISION MADE: 18-MAY-09 HOECHBERG GM 97204 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALGISEAL PAD EVOLUTION MEDICAL TECHNOLOGIES LLC510(k) NO: K091194(TRADITIONAL) ATTN: JOHN MANNING PHONE NO : 877 386 3307 3439 NE SANDY BLVD. SUITE 142 SE DECISION MADE: 18-MAY-09 PORTLAND OR 97232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT POWER MEDICAL INTERVENTIONS, INC. 510(k) NO: K091215(SPECIAL) ATTN: BARBARA J WHITMAN PHONE NO : 267 775 8151 2021 CABOT BLVD. SE DECISION MADE: 18-MAY-09 LANGHORNE PA 19047 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS AGFA HEALTHCARE N.V. 510(k) NO: K090672(TRADITIONAL) ATTN: JEFFERY A JEDLICKA PHONE NO : 864 421 1815 SEPTESTRAAT 27 SE DECISION MADE: 18-MAY-09 MORTSEL BE B 2640 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MY LABS25 GOLD/MYLAB30 GOLD CARDIOVASCULAR MODEL 7340, MY LAB70/MY LAB70XVISION/MYLAB60, MODEL 6150 ESAOTE S.P.A. 510(k) NO: K091009(TRADITIONAL) ATTN: ALLISON SCOTT PHONE NO : 317 569 9500 11460 N. MERIDIAN ST. SUITE 150 SE DECISION MADE: 18-MAY-09 CARMEL IN 46032 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DEPUY SPINE LATERAL SYSTEM DEPUY SPINE, INC. 510(k) NO: K090899(TRADITIONAL) ATTN: DENISE DUCHENE PHONE NO : 508 828 3065 325 PARAMOUNT DR. SE DECISION MADE: 19-MAY-09 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM SIERRA SCIENTIFIC INSTRUMENTS, INC510(k) NO: K091070(TRADITIONAL) ATTN: REIC S FINKELMAN PHONE NO : 310 641 8492 5757 CENTURY BLVD. SUITE 660 SE DECISION MADE: 19-MAY-09 LOS ANGELES CA 90045 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: EG-3670URK PENTAX MEDICAL COMPANY 510(k) NO: K090196(TRADITIONAL) ATTN: PAUL SILVA PHONE NO : 800 431 5880 102 CHESTNUT RIDGE RD. SE DECISION MADE: 19-MAY-09 MONTVALE NJ 07645 1856 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EG-3870UTK PENTAX MEDICAL COMPANY 510(k) NO: K090197(TRADITIONAL) ATTN: PAUL SILVA PHONE NO : 800 431 5880 102 CHESTNUT RIDGE RD. SE DECISION MADE: 19-MAY-09 MONTVALE NJ 07645 1856 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GUIDED LATERAL INTERBODY FUSION (GLIF) SYSTEM ALPHATEC SPINE, INC. 510(k) NO: K090425(TRADITIONAL) ATTN: MARY STANNERS PHONE NO : 760 494 6771 5818 EL CAMINO REAL SE DECISION MADE: 19-MAY-09 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BONGROS HA BIOALPHA, INC. 510(k) NO: K090793(TRADITIONAL) ATTN: HYUN-SEUNG RYU PHONE NO : 823 174 65209 223-23 SANGDAEWON-DONG JUNGWON-GU SE DECISION MADE: 19-MAY-09 SEONGNAM, GYEONGGI-DO KS 462-12510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BABI*PLUS BUBBLE PAP VALVE A PLUS MEDICAL 510(k) NO: K090317(TRADITIONAL) ATTN: THOMAS C LOESCHER PHONE NO : 760 930 4025 5431 AVENIDA ENCINAS SUITE G SE DECISION MADE: 20-MAY-09 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWER INFUSER, MODEL M100B-3A ZOLL MEDICAL CORPORATION 510(k) NO: K090736(TRADITIONAL) ATTN: EILEEN M BOYLE PHONE NO : 978 421 9171 269 MILL ROAD SE DECISION MADE: 20-MAY-09 CHELMSFORD MA 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HINGE PEDIATRIC PLATING SYSTEM PEGA MEDICAL INC. 510(k) NO: K090440(TRADITIONAL) ATTN: ARIEL DUJOVNE PHONE NO : 450 688 5144 1105 AUTOROUTE CHOMEDEY SE DECISION MADE: 20-MAY-09 LAVAL, QUEBEC CA H7W 5J8 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUSION MEDICAL STI JOHN RICCIO 510(k) NO: K081755(TRADITIONAL) ATTN: JOHN RICCIO PHONE NO : 203 823 8511 1663 SOUTH MAIN STREET SE DECISION MADE: 20-MAY-09 WATERBURY CT 06706 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUPRATHEL WOUND AND BURN DRESSING POLYMEDICS INNOVATIONS GMBH 510(k) NO: K090160(TRADITIONAL) ATTN: KENNETH K KLEINHENZ PHONE NO : 858 458 0900 HEERWEG 15D SE DECISION MADE: 20-MAY-09 DENKENDORF GM D-73770 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZELTIQ SYSTEM ZELTIQ AESTHETICS 510(k) NO: K090094(SPECIAL) ATTN: DONALD V JOHNSON PHONE NO : 925 474 2509 4698 WILLOW ROAD SE DECISION MADE: 20-MAY-09 PLEASANTON CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OCULUS MICROCYN WOUND GEL OCULUS INNOVATIVE SCIENCES, INC. 510(k) NO: K090725(TRADITIONAL) ATTN: ANTIOINETTE DOUGLAS PHONE NO : 707 283 0550 1135 N. MC DOWELL BLVD SE DECISION MADE: 20-MAY-09 PETALUMA CA 94954 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPIN-LOC SUTURE ANCHOR SYSTEM FG-0302-01,FG-0305-01 ROSS CREEK MEDICAL INC. 510(k) NO: K090530(TRADITIONAL) ATTN: MICHAEL KOLBER PHONE NO : 408 505 6626 14734 LA RINCONADA DRIVE SE DECISION MADE: 20-MAY-09 LOS GATOS CA 95032 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APLION TOPICAL CARE SYSTEM APLION MEDICAL,LLC 510(k) NO: K091133(TRADITIONAL) ATTN: CURTIS JENSEN PHONE NO : 801 972 2455 2425 SOUTH 900 WEST SE DECISION MADE: 20-MAY-09 SALT LAKE CITY UT 84119 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNERGEYES SIG (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS SYNERGEYES, INC. 510(k) NO: K083921(TRADITIONAL) ATTN: RICHARD E LIPPMAN PHONE NO : 240 683 3738 15825 SHADY GROVE ROAD SUITE 30 SE DECISION MADE: 20-MAY-09 ROCKVILLE MD 20850 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNGO TRUED SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K091373(TRADITIONAL) ATTN: JAMES E KUHN JR PHONE NO : 610 448 3006 20 VALLEY STREAM PKWY. SE DECISION MADE: 20-MAY-09 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY DIAGNOSTIC HYBRIDS, INC. 510(k) NO: K083391(TRADITIONAL) ATTN: GAIL R GOODRUM PHONE NO : 740 589 3380 1055 EAST STATE STREET SUITE 100 SE DECISION MADE: 21-MAY-09 ATHENS OH 45701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES SYNAPSE TRANSCONNECTOR SYNTHES SPINE 510(k) NO: K090549(SPECIAL) ATTN: STACEY BONNELL PHONE NO : 610 719 5895 1302 WRIGHTS LANE EAST SE DECISION MADE: 21-MAY-09 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERCUTANEOUS DISCECTOMY SYSTEM LAURIMED LLC 510(k) NO: K090815(TRADITIONAL) ATTN: SEVRINA CIUCCI PHONE NO : 408 316 4837 500 ARGUELLO STREET, SUITE 100 SE DECISION MADE: 21-MAY-09 REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INVACARE TPOC PORTABLE CONCENTRATOR, MODEL TPOC100 INVACARE CORPORATION 510(k) NO: K083751(TRADITIONAL) ATTN: CARROLL MARTIN PHONE NO : 440 329 6356 ONE INVACARE WAY PO BOX 4028 SE DECISION MADE: 21-MAY-09 ELYRIA OH 44036 2125 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORALUBE PULPDENT CORPORATION 510(k) NO: K090457(TRADITIONAL) ATTN: KENNETH J BERK PHONE NO : 617 926 6666 80 OAKLAND ST. SE DECISION MADE: 21-MAY-09 WATERTOWN MA 02472 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: METAMORPHOSIS KERR CORPORATION 510(k) NO: K091023(TRADITIONAL) ATTN: WENDY GARMAN PHONE NO : 714 516 7602 1717 WEST COLLINS AVENUE SE DECISION MADE: 21-MAY-09 ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-M PRIMUS STERILIZER COMPANY, LLC. 510(k) NO: K082817(TRADITIONAL) ATTN: LYLE LOHRMEYER PHONE NO : 620 793 7900 5520 10TH ST. SE DECISION MADE: 21-MAY-09 GREAT BEND KS 67530 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG MEDICALGORITHMICS SP Z.O.O. 510(k) NO: K090037(ABBREVIATED) ATTN: MARTIN JASINSKI PHONE NO : 917 941 9581 245 WEST 107TH STREET SUITE 11A SE DECISION MADE: 22-MAY-09 NEW YORK NY 10025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENABLER-P CATHETER, 1000 PART NUMBER:1160 ENDOCROSS, LTD. 510(k) NO: K083833(TRADITIONAL) ATTN: JOHN SMITH PHONE NO : 202 637 3638 555 THIRTEENTH STREET NW SE DECISION MADE: 22-MAY-09 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010 ST. JUDE MEDICAL 510(k) NO: K083328(SPECIAL) ATTN: KAREN MCKELVEY PHONE NO : 651 632 9454 1350 ENERGY LN., SUITE 110 SE DECISION MADE: 22-MAY-09 ST. PAUL MN 55108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FREEHAND PROSURGICS LIMITED 510(k) NO: K090340(SPECIAL) ATTN: GEROGE MYERS PHONE NO : 201 727 1703 377 ROUTE 17S SE DECISION MADE: 22-MAY-09 HASBROUCK HEIGHTS NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS DEPUY SPINE, INC. 510(k) NO: K081917(TRADITIONAL) ATTN: SHARON STAROWICZ PHONE NO : 508 828 2867 325 PARAMOUNT DR. SE DECISION MADE: 22-MAY-09 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPRO FEMORAL HEADS BIOPRO, INC. 510(k) NO: K090208(TRADITIONAL) ATTN: DAVID MRAK PHONE NO : 810 982 7777 17 SEVENTEENTH ST. SE DECISION MADE: 22-MAY-09 PORT HURON MI 48060 510(k) STATEMENT DEVICE: ANKYLOS C/X DENTAL IMPLANT SYSTEM DENTSPLY INTL., INC. 510(k) NO: K083805(TRADITIONAL) ATTN: HELEN LEWIS PHONE NO : 717 849 4229 SUSQUEHANNA COMMERCE CENTER 221W PSE DECISION MADE: 22-MAY-09 YORK PA 17404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES ANTHOGYR 510(k) NO: K090676(SPECIAL) ATTN: BRAYETTE SABINE PHONE NO : 33 450 580237 2237 AVENUE ANDRE LASQUIN SE DECISION MADE: 22-MAY-09 SALLANCHES FR 74700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TERUMO SYRINGE WITH/WITHOUT NEEDLE TERUMO EUROPE N.V. 510(k) NO: K083514(TRADITIONAL) ATTN: M.J. AERTS PHONE NO : 321 638 1211 INTERLEUVENLAAN 40 RESEARCHPARK ZOSE DECISION MADE: 22-MAY-09 LEUVEN BE 3001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER GULF COAST HYPERBARICS, INC. 510(k) NO: K082455(TRADITIONAL) ATTN: JAMES W MCCARTHY PHONE NO : 850 271 1441 1100 WEST 26TH ST. SE DECISION MADE: 22-MAY-09 LYNN HAVEN FL 32444 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C-PORT - HP "POWER INJECTABLE" PORT PHS MEDICAL GMBH 510(k) NO: K091099(TRADITIONAL) ATTN: DONALD F HULTS PHONE NO : 214 549 9208 2360 JOHNSON RD. SE DECISION MADE: 22-MAY-09 SOUTHLAKE TX 76092 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEOSS IMPLANT SYSTEM 03.25 NEOSS LTD 510(k) NO: K090452(TRADITIONAL) ATTN: CHERITA JAMES PHONE NO : 703 562 9800 901 KING STREET SUITE 200 SE DECISION MADE: 22-MAY-09 ALEXANDRIA VA 22314 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270 SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K090330(TRADITIONAL) ATTN: ROSE T MARINELLI PHONE NO : 302 631 8805 PO BOX 6101 MS 514 SE DECISION MADE: 22-MAY-09 NEWARK DE 19714 6101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRAUMANN MEMBRAGEL INSTITUT STRAUMANN AG 510(k) NO: K082111(TRADITIONAL) ATTN: LISA QUAGLIA PHONE NO : 978 747 2575 60 MINUTEMAN ROAD SE DECISION MADE: 22-MAY-09 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0 TOMTEC IMAGING SYSTEMS, GMBH 510(k) NO: K090461(TRADITIONAL) ATTN: INGE SCHEIDT PHONE NO : 49 89 32175515 EDISONSTRASSE 6 SE DECISION MADE: 22-MAY-09 UNTERSCHLEISSHEIM GM D-85716 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A TERUMO CORP. 510(k) NO: K091417(TRADITIONAL) ATTN: MARK UNTERREINER PHONE NO : 410 392 7213 950 ELKTON BLVD. SE DECISION MADE: 22-MAY-09 ELKTON MD 21921 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034 BAROSENSE, INC 510(k) NO: K082589(TRADITIONAL) ATTN: DANIEL J BALBIERZ PHONE NO : 650 362 6001 3698-C HAVEN AVENUE SE DECISION MADE: 22-MAY-09 REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARESTREAM DRYVIEW 5850 LASER IMAGER CARESTREAM HEALTH, INC. 510(k) NO: K090469(TRADITIONAL) ATTN: GAYLE CARROLL PHONE NO : 651 393 1501 1 IMATION WAY 304-4B-28 SE DECISION MADE: 22-MAY-09 OAKDALE MN 55128 3414 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIAGNOSTIC CATHETER SYSTEM CARDINAL HEALTH, INC. 510(k) NO: K091250(TRADITIONAL) ATTN: SHARON NICHOLS PHONE NO : 847 578 6610 1430 WAUKEGAN ROAD- MPKB-3B SE DECISION MADE: 22-MAY-09 MCGAW PARK IL 60085 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CAAS MR FLOW 1.0 PIE MEDICAL IMAGING B.V. 510(k) NO: K090155(TRADITIONAL) ATTN: SASKIA LLOYD PHONE NO : 31 43 3281324 BECANUSSTRAAT 13 D SE DECISION MADE: 22-MAY-09 MAASTRICHT NL 6216 BX 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K090257(TRADITIONAL) ATTN: CLARE SANTULLI PHONE NO : 914 524 2701 511 BENEDICT AVENUE SE DECISION MADE: 26-MAY-09 TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUSION MEDICAL CANNULATED SCREW SYSTEM JOHN RICCIO 510(k) NO: K081122(TRADITIONAL) ATTN: JOHN RICCIO PHONE NO : 203 823 8511 1663 SOUTH MAIN STREET SE DECISION MADE: 26-MAY-09 WATERBURY CT 06706 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 249 TOTAL WITH SUMMARIES 223 TOTAL WITH STATEMENTS 26
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