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510(k)s Final Decisions Rendered for March 2005 |
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SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-MAR-2005 THROUGH 31-MAR-2005 DEVICE: A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR A & D ENGINEERING, INC. 510(k) NO: K043217(SPECIAL)
ATTN: JERRY WANG PHONE NO : 408-518-5113 1555 MCCANDLESS DR. SE DECISION MADE: 03-MAR-05 MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIA ABBOTT VASCULAR DEVICES 510(k) NO: K050501(SPECIAL)
ATTN: ANN E LEONARD PHONE NO : 650-474-3477 400 SAGINAW DR. SE DECISION MADE: 14-MAR-05 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PACHPEN PACHYMETER, MODEL 24-5100 ACCUTOME, INC. 510(k) NO: K050552(TRADITIONAL)
ATTN: JEFFREY L WRIGHT PHONE NO : 610-889-0200 263 GREAT VALLEY PKWY. SE DECISION MADE: 28-MAR-05 MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUAL LUMEN CATHETER ACMI CORPORATION 510(k) NO: K043581(SPECIAL)
ATTN: GRAHAM BAILLIE PHONE NO : 508-804-2600 136 TURNPIKE RD. SE DECISION MADE: 03-MAR-05 SOUTHBOROUGH, MA 01772 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ON CALL MULTI-DRUG HOME TEST ACON LABORATORIES, INC. 510(k) NO: K050050(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030 4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 11-MAR-05 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCUHEART ELECTRODE BELT ADVANCED BIOELECTRIC CORPORATION 510(k) NO: K043361(TRADITIONAL)
ATTN: MARC-ANDRE COTE PHONE NO : 514 501 8316 2160 JOHNSON STREET SE DECISION MADE: 22-MAR-05 SAINT-LAURENT, QUEBEC, CANADA H4M 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AOS HUMERAL NAIL ADVANCED ORTHOPAEDIC SOLUTIONS, IN510(k) NO: K050241(TRADITIONAL)
ATTN: GARY SOHNGEN PHONE NO : 310-831-4433 333 WEST 6TH ST., SUITE 202 SE DECISION MADE: 14-MAR-05 SAN PEDRO, CA 90731 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM ADVANCED STERILIZATION PRODUCTS 510(k) NO: K040883(TRADITIONAL)
ATTN: NEELU MEDHEKAR PHONE NO : 949-789-3838 33 TECHNOLOGY DR. SE DECISION MADE: 15-MAR-05 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AURA CPAP SYSTEM AEIOMED INC. 510(k) NO: K042945(ABBREVIATED)
ATTN: GARY SYRING PHONE NO : 608-877-2635 800 LEVANGER LANE SE DECISION MADE: 09-MAR-05 STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXCIA TOTAL HIP SYSTEM AESCULAP, INC. 510(k) NO: K042344(ABBREVIATED)
ATTN: JOYCE KILROY PHONE NO : 800-258-1946 3773 CORPORATE PKWY. SE DECISION MADE: 16-MAR-05 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: INSTAREAD LITHIUM SYSTEM AKERS BIOSCIENCES, INC. 510(k) NO: K050338(SPECIAL)
ATTN: ERIKA AMMIRATI PHONE NO : 856-848-8698 201 GROVE RD. SE DECISION MADE: 04-MAR-05 THOROFARE, NJ 08086 510(k) STATEMENT DEVICE: REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER ALLIANCE MEDICAL CORP. 510(k) NO: K033436(TRADITIONAL)
ATTN: MOIRA BARTON PHONE NO : 480-763-5350 10232 SOUTH 51ST ST. SE DECISION MADE: 16-MAR-05 PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED ELECTROPHYSIOLOGY CATHETERS ALLIANCE MEDICAL CORP. 510(k) NO: K043392(TRADITIONAL)
ATTN: MOIRA BARTON PHONE NO : 480-763-5350 10232 SOUTH 51ST ST. SE DECISION MADE: 25-MAR-05 PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS ALLIANCE MEDICAL CORP. 510(k) NO: K043393(TRADITIONAL)
ATTN: JENN SELVEY PHONE NO : 480-763-5386 10232 SOUTH 51ST ST. SE DECISION MADE: 23-MAR-05 PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TAMARACK ANTERIOR THORACOLUNBAR ALPHATEC/NEXMED 510(k) NO: K050390(TRADITIONAL)
ATTN: ELLEN A YARMALL PHONE NO : 760-431-9286 6110 CORTE DEL CEDRO SE DECISION MADE: 14-MAR-05 CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL III AMEDITECH, INC. 510(k) NO: K050186(TRADITIONAL)
ATTN: JOHN WU PHONE NO : 858-535-1968 10340 CAMINO SANTA FE, SUITE F SE DECISION MADE: 04-MAR-05 SAN DIEGO, CA 92121 510(k) STATEMENT DEVICE: XP TECHNOLOGY ULTRASONIC SCALER AMERICAN EAGLE INSTRUMENTS, INC. 510(k) NO: K042972(TRADITIONAL)
ATTN: TOM THOMPSON PHONE NO : 406-549-7451 6575 BUTLER CREEK RD. SE DECISION MADE: 18-MAR-05 MISSOULA, MT 59808 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMPLIEF WRIST BLOOD PRESSURE MONITOR, MODEL M600 AMPLIFE CORPORATION 510(k) NO: K050413(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 04-MAR-05 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: VOYAGER PERSONAL IMAGING DEVICE ARDENT SOUND, INC. 510(k) NO: K050551(TRADITIONAL)
ATTN: PETER G BARTHE PHONE NO : 480-649-1806 33 S. SYCAMORE STREET SE DECISION MADE: 22-MAR-05 MESA, AZ 85202 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MODIFICATION TO: ARTHREX V-TAK ARTHREX, INC. 510(k) NO: K050634(SPECIAL)
ATTN: ANN WATERHOUSE, RAC PHONE NO : 239-643-5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 21-MAR-05 NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AEU-14CF EXPENDITION ASEPTICO, INC. 510(k) NO: K050201(TRADITIONAL)
ATTN: GRANT RAMALEY PHONE NO : 425-487-3157 8333 216TH ST., S.E. SE DECISION MADE: 18-MAR-05 WOODINVILLE, WA 98072 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ATLANTIS ABUTMENT FOR STRAUMANN INTERFACE ATLANTIS COMPONENTS, INC. 510(k) NO: K050052(TRADITIONAL)
ATTN: BETSY A BROWN PHONE NO : 847-560-4406 8944 TAMAROA TERRACE SE DECISION MADE: 07-MAR-05 SKOKIE, IL 60076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT BECKMAN COULTER, INC. 510(k) NO: K043556(TRADITIONAL)
ATTN: ANNETTE HELLIE PHONE NO : 714-993-8767 200 SOUTH KRAEMER BLVD. SE DECISION MADE: 28-MAR-05 BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTETAN (GN) 2-64 U BECTON, DICKINSON & CO. 510(k) NO: K043458(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287 7 LOVETON CIR. SE DECISION MADE: 15-MAR-05 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GP) 0.5- BECTON, DICKINSON & CO. 510(k) NO: K050400(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287 7 LOVETON CIR. SE DECISION MADE: 22-MAR-05 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEUROTECH KNEEHAB BIO-MEDICAL RESEARCH, LTD. 510(k) NO: K024258(TRADITIONAL)
ATTN: ANNE-MARIE KEENAN PHONE NO : 353 917 74350 PARKMORE BUSINESS PARK, SE DECISION MADE: 04-MAR-05 WEST GALWAY, IRELAND 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL BIO-RAD 510(k) NO: K050536(TRADITIONAL) ATTN: MARIA ZEBALLOS PHONE NO : 949-598-1367 9500 JERONIMO RD. SE DECISION MADE: 24-MAR-05 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PREGNANCY-SKREEN BIOCHEMICAL DIAGNOSTIC, INC. 510(k) NO: K050328(TRADITIONAL)
ATTN: ALLEN PANETZ PHONE NO : 631-595-9200 180 HEARTLAND BLVD. SE DECISION MADE: 29-MAR-05 BRENTWOOD, NY 11717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARI-KAD PACKING DEVICE BIOENVELOP AGRO, INC. 510(k) NO: K050318(TRADITIONAL)
ATTN: ROBERT SCHIFF PHONE NO : 973-227-1830 1129 BLOOMFIELD AVENUE SE DECISION MADE: 04-MAR-05 WEST CALDWELL, NJ 07006 510(k) STATEMENT DEVICE: HYPERQ SYSTEM BIOLOGICAL SIGNAL PROCESSING LTD. 510(k) NO: K042981(TRADITIONAL)
ATTN: ARAVA HACOHEN PHONE NO : 972 976 70002 20 HATA'AS ST SE DECISION MADE: 10-MAR-05 KFAR SABA, ISRAEL 44425 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL BMLS03-7 BIOMEDICAL LIFE SYSTEMS, INC. 510(k) NO: K042711(TRADITIONAL)
ATTN: GARY BUSSETT PHONE NO : 760-727-5600 P.O. BOX 1360 SE DECISION MADE: 14-MAR-05 VISTA, CA 92085-1360 510(k) STATEMENT DEVICE: MAESTRO CARPAL HEMIARTHROPLASTY BIOMET MANUFACTURING, INC. 510(k) NO: K050028(TRADITIONAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639 56 EAST BELL DR. SE DECISION MADE: 25-MAR-05 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: ARCOMXL POLYETHYLENE LINERS BIOMET, INC. 510(k) NO: K042051(TRADITIONAL)
ATTN: TRACY J BICKEL PHONE NO : 574-267-6639 56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 08-MAR-05 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOLOX DELTA CERAMIC HEADS BIOMET, INC. 510(k) NO: K042091(TRADITIONAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639 P.O. BOX 587 SE DECISION MADE: 25-MAR-05 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOSYAG 50 MED BIOS S.R.L. 510(k) NO: K043521(TRADITIONAL)
ATTN: ALESSANDRO FRANCHI ONDE PHONE NO : 240-305-6868 16 INDIAN SPRING DR SE DECISION MADE: 24-MAR-05 SILVER SPRING, MD 20901 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARTO XP EP NAVIGATION SYSTEM, SOFTWARE VERISON 8 BIOSENSE WEBSTER, INC. 510(k) NO: K042999(TRADITIONAL)
ATTN: MARK O'DONNELL PHONE NO : 909-839-8466 3333 DIAMOND CANYON RD. SE DECISION MADE: 21-MAR-05 DIAMOND BAR, CA 91765 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING BIOSENSE WEBSTER, INC. 510(k) NO: K050217(TRADITIONAL)
ATTN: WAYNE R HOHMAN PHONE NO : 800-729-9010 3333 DIAMOND CANYON RD. SE DECISION MADE: 30-MAR-05 DIAMOND BAR, CA 91765 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIAGE TOX DRUG SCREEN CONTROLS BIOSITE INCORPORATED 510(k) NO: K050037(TRADITIONAL)
ATTN: JEFFREY R DAHLEN PHONE NO : 858-455-4808 11030 ROSELLE ST. SE DECISION MADE: 22-MAR-05 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GALEO FOCUS GUIDE WIRE BIOTRONIK, INC. 510(k) NO: K042373(TRADITIONAL)
ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374 6024 JEAN RD. SE DECISION MADE: 02-MAR-05 LAKE OSWEGO, OR 97035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PIVOT STEERABLE MICROCATHETER BOSTON SCIENTIFIC - PRECISION VASC510(k) NO: K050630(SPECIAL)
ATTN: RICK GAYKOWSKI PHONE NO : 801-974-1736 2405 WEST ORTON CIR. SE DECISION MADE: 22-MAR-05 WEST VALLEY CITY, UT 84119 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR BOSTON SCIENTIFIC CORP. 510(k) NO: K050232(SPECIAL)
ATTN: PAIGE SWEENEY PHONE NO : 508-652-5560 ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 11-MAR-05 NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO CONCERTO BIPOLAR NEEDLE ELECTRODE BOSTON SCIENTIFIC CORP. 510(k) NO: K050361(SPECIAL)
ATTN: NICHOLAS CONDAKES PHONE NO : 508-683-4003 100 FAIRBANKS BOULEVARD SE DECISION MADE: 14-MAR-05 MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPYGLASS DIRECT VISULATION PROBE BOSTON SCIENTIFIC CORP. 510(k) NO: K050403(TRADITIONAL)
ATTN: KATHLEEN MORAHAN PHONE NO : 508-652-5942 ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 04-MAR-05 NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014 BOSTON SCIENTIFIC CORP. 510(k) NO: K050577(SPECIAL)
ATTN: VERONICA M KOCKEN PHONE NO : 510-624-1431 47201 LAKEVIEW BLVD. SE DECISION MADE: 30-MAR-05 FREMONT, CA 94537 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BODYGUARD INFUSION PUMP SYSTEM CAESAREA MEDICAL ELECTRONICS LTD. 510(k) NO: K042696(TRADITIONAL)
ATTN: GALI TZURY PHONE NO : 972 462 71737 16 SHACHAM STREET SE DECISION MADE: 11-MAR-05 INDUSTRIAL PARK 510(k) STATEMENT CAESAREA, ISRAEL 38900 DEVICE: SE INFUSION SYSTEM WITH MMS CARDINAL HEALTH, ALARIS PRODUCTS 510(k) NO: K043590(TRADITIONAL)
ATTN: STACY L LEWIS PHONE NO : 858-458-7830 10221 WATERIDGE CIRCLE SE DECISION MADE: 25-MAR-05 SAN DIEGO, CA 92121-2772 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 14F DUAL FLOATING DIALYSIS CATHETER/TRAY CARDIOMED SUPPLIES, INC. 510(k) NO: K042672(TRADITIONAL)
ATTN: CHRISTIAN G DUBE PHONE NO : 905 888 1965 5 GORMLEY INDUSTRIAL AVENUE SE DECISION MADE: 23-MAR-05 GORMLEY, ONTARIO, CANADA L0H 1G0 510(k) STATEMENT DEVICE: CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000 CARDIOMEDICS, INC. 510(k) NO: K050172(TRADITIONAL)
ATTN: JOHN HUTCHINS PHONE NO : 949-863-2500 18872 BARDEEN AVE. SE DECISION MADE: 31-MAR-05 IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMAGENPRO CARDIOVASCULAR IMAGING TECHNOLOGIE510(k) NO: K050366(TRADITIONAL)
ATTN: MELANIE HASEK PHONE NO : 816-347-9224 200 N.E. MULBERRY SE DECISION MADE: 17-MAR-05 LEE'S SUMMIT, MO 64086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CIE FOLDAWAY WHEELCHAIR CARLSBARD INTERNATIONAL EXPORT INC510(k) NO: K050345(TRADITIONAL)
ATTN: LAURA MEYER PHONE NO : 1954 KELLOGG AVE. SE DECISION MADE: 29-MAR-05 CARLSBAD, CA 92008 510(k) STATEMENT DEVICE: AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLEN CEREMED, INC. 510(k) NO: K043133(TRADITIONAL)
ATTN: TADEUSZ WELLISZ PHONE NO : 310-815-2125 3643 LENAWEE AVE. SE DECISION MADE: 02-MAR-05 LOS ANGELES, CA 90016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, CEREMED, INC. 510(k) NO: K050440(SPECIAL)
ATTN: TADEUSZ WELLISZ PHONE NO : 310-815-2125 3643 LENAWEE AVE. SE DECISION MADE: 24-MAR-05 LOS ANGELES, CA 90016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALLIGATOR RETRIEVAL DEVICE (ARD) CHESTNUT MEDICAL TECHNOLOGIES, INC510(k) NO: K043580(TRADITIONAL)
ATTN: ANNA LONGWELL PHONE NO : 650-213-9162 3583 ROSS ROAD SE DECISION MADE: 24-MAR-05 PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: FRESHLOOK ONE-DAY COLOR CONTACT LENS CIBA VISION CORPORATION 510(k) NO: K050213(TRADITIONAL)
ATTN: ANGELA L BUNN PHONE NO : 678-415-3784 11460 JOHNS CREEK PARKWAY SE DECISION MADE: 28-MAR-05 DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN CLEMENT CLARKE INTL., LTD. 510(k) NO: K042058(TRADITIONAL)
ATTN: PHILIP HALLYBONE PHONE NO : 44 012 79414969 EDINBURGH WAY SE DECISION MADE: 23-MAR-05 HARLOW, ESSEX, UNITED KINGDOM CM20510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG COBE CARDIOVASCULAR, INC. 510(k) NO: K050111(ABBREVIATED)
ATTN: EDWARD E NEWTON PHONE NO : 512-435-3405 14401 WEST 65TH WAY SE DECISION MADE: 08-MAR-05 ARVADA, CO 80004-3599 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEMPOSIL, MODEL 6720 COLTENE/WHALEDENT AG 510(k) NO: K050426(TRADITIONAL)
ATTN: HENRY J VOGELSTEIN PHONE NO : 212-289-4748 1349 LEXINGTON AVENUE SE DECISION MADE: 18-MAR-05 NEW YORK, NY 10128 510(k) STATEMENT DEVICE: UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD CONFORMIS, INC. 510(k) NO: K043570(TRADITIONAL)
ATTN: LYNDALL ERB PHONE NO : 650-286-4166 323 C VINTAGE PARK DR. SE DECISION MADE: 14-MAR-05 FOSTER CITY, CA 94404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FX WIRE ADVANCED MEASUREMENT GUIDEWIRE CONMED CORP. 510(k) NO: K050304(SPECIAL)
ATTN: THOMAS HIRTE PHONE NO : 978-964-4252 129 CONCORD ROAD SE DECISION MADE: 08-MAR-05 BUILDING 3 510(k) SUMMARY AVAILABLE FROM FDA BILLERICA, MA 01821 DEVICE: SIS FISTULA PLUG COOK BIOTECH, INC. 510(k) NO: K050337(TRADITIONAL)
ATTN: MARK BLEYER PHONE NO : 765-497-3355 1425 INNOVATION PLACE SE DECISION MADE: 09-MAR-05 WEST LAFAYETTE, IN 47906 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOK IRELAND SONNET POLYPECTOMY SNARE COOK IRELAND LTD 510(k) NO: K050294(TRADITIONAL)
ATTN: EMMETT DEVEREUX PHONE NO : 353 613 34440 O'HOLLORAN ROAD SE DECISION MADE: 31-MAR-05 NATIONAL TECHNOLOGICAL PARK 510(k) SUMMARY AVAILABLE FROM FDA LIMERICK, IRELAND DEVICE: COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH COOK UROLOGICAL, INC. 510(k) NO: K043418(TRADITIONAL)
ATTN: CINDY RUMPLE PHONE NO : 812-829-4891 1100 WEST MORGAN ST. SE DECISION MADE: 31-MAR-05 P.O. BOX 227 510(k) SUMMARY AVAILABLE FROM FDA SPENCER, IN 47460 DEVICE: MODIFICATION TO:ZILVER 518 BILIARY STENT COOK, INC. 510(k) NO: K050698(SPECIAL)
ATTN: STEPHANIE ROBERTS PHONE NO : 812-339-2235 750 DANIELS WAY PO BX 489 SE DECISION MADE: 30-MAR-05 BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL COSMAN MEDICAL, INC. 510(k) NO: K050084(TRADITIONAL)
ATTN: MICHAEL ARNOLD PHONE NO : 781-272-6561 76 CAMBRIDGE ST. SE DECISION MADE: 17-MAR-05 BURLINGTON, MA 01803-4140 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS CRYOMEDICAL INSTRUMENTS, LTD. 510(k) NO: K050272(TRADITIONAL)
ATTN: GARETH COPPING PHONE NO : 44 162 3424200 GROVE WAY SE DECISION MADE: 24-MAR-05 MANSFIELD WOODHOUSE 510(k) SUMMARY AVAILABLE FROM FDA MANSFIELD, UNITED KINGDOM NG19 8BW DEVICE: LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I CTI PET SYSTEMS, INC. 510(k) NO: K050509(SPECIAL)
ATTN: ALAINE MEDIO PHONE NO : 865-218-2703 810 INNOVATION DR. SE DECISION MADE: 25-MAR-05 KNOXVILLE, TN 37932-2571 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CUTERA OPTIONAL PULSED LIGHT HAND PIECE FAMILY CUTERA, INC. 510(k) NO: K050047(TRADITIONAL)
ATTN: KATHY MAYNOR PHONE NO : 415-657-5586 3240 BAYSHORE BLVD. SE DECISION MADE: 31-MAR-05 BRISBANE, CA 94005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CUTERA SOLERA OPUS AESTHETIC PRODUCT CUTERA, INC. 510(k) NO: K050679(TRADITIONAL) ATTN: KATHY MAYNOR PHONE NO : 415-657-5586 3240 BAYSHORE BLVD. SE DECISION MADE: 31-MAR-05 BRISBANE, CA 94005 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM CYBERKINETICS, INC. 510(k) NO: K042626(TRADITIONAL)
ATTN: NANDINI MURTHY PHONE NO : 508-549-9981 100 FOXBORO BLVD. SUITE 240 SE DECISION MADE: 28-MAR-05 FOXBORO, MA 02035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM CYBERKINETICS, INC. (CKI) 510(k) NO: K042384(TRADITIONAL)
ATTN: NANDINI MURTHY PHONE NO : 508-549-9981 391 CHIPETA WAY SE DECISION MADE: 29-MAR-05 SUITE G 510(k) SUMMARY AVAILABLE FROM FDA SALT LAKE CITY, UT 84108 DEVICE: MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN DADE BEHRING, INC. 510(k) NO: K050043(TRADITIONAL)
ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105 2040 ENTERPRISE BLVD. SE DECISION MADE: 29-MAR-05 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS AMOXICILLIN/K. CL DADE BEHRING, INC. 510(k) NO: K050585(SPECIAL)
ATTN: ROBERT EUSEBIO PHONE NO : 916-374-3183 2040 ENTERPRISE BLVD. SE DECISION MADE: 18-MAR-05 WEST SACRAMENTO, CA 95691 510(k) STATEMENT DEVICE: MIN-FILTER/S, UNI-FILTER JUNIOR, UNI-FILTER/S ANGLED AND UNI-FIL DATEX-OHMEDA, INC. 510(k) NO: K043120(TRADITIONAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685 86 PILGRIM RD. SE DECISION MADE: 01-MAR-05 NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE DATEX-OHMEDA ENGSTROM CARESTATION DATEX-OHMEDA, INC. 510(k) NO: K050597(SPECIAL)
ATTN: DAN KOSEDNAR PHONE NO : 608-221-1551 PO BOX 7550 SE DECISION MADE: 25-MAR-05 MADISON, WI 53707 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE DATEX-OHMEDA AESPIRE 7900 ANESTHESIA SYSTEM DATEX-OHMEDA, INC. 510(k) NO: K050626(SPECIAL)
ATTN: DAN KOSEDNAR PHONE NO : 608-221-1551 P.O. BOX 7550 SE DECISION MADE: 25-MAR-05 MADISON, WI 53707 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY CAS KNEE INSTRUMENTATION DEPUY ORTHOPAEDICS, INC. 510(k) NO: K043223(TRADITIONAL)
ATTN: RANDA FRANKLIN PHONE NO : 574-371-4906 700 ORTHOPAEDIC DR. SE DECISION MADE: 04-MAR-05 WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PINNACLE CONSTRAINED ACETABULAR LINERS DEPUY, INC. 510(k) NO: K043058(TRADITIONAL)
ATTN: NATALIE HECK PHONE NO : 574-371-4905 700 ORTHOPAEDIC DR. SE DECISION MADE: 14-MAR-05 WARSAW, IN 46582 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM DIALYSIS SERVICES, INC. 510(k) NO: K043344(TRADITIONAL)
ATTN: MIKE STERLING PHONE NO : 615-384-4810 3620 KELTON JACKSON RD. SE DECISION MADE: 23-MAR-05 SPRINGFIELD, TN 37172 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR DIDECO S.R.L. 510(k) NO: K050447(SPECIAL)
ATTN: BARRY SALL PHONE NO : 781-434-4742 195 WEST ST. SE DECISION MADE: 08-MAR-05 WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENFANTTM DIOPSYS INC. 510(k) NO: K043491(TRADITIONAL)
ATTN: JOSEPH FONTANETTA PHONE NO : 973-244-0622 16 CHAPIN ROAD SUITE 911 SE DECISION MADE: 16-MAR-05 P.O. BOX 672 510(k) SUMMARY AVAILABLE FROM FDA PINE BROOK, NJ 07058 DEVICE: TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE) DIREX SYSTEMS CORP. 510(k) NO: K050091(SPECIAL)
ATTN: LARISA GERSTEIN PHONE NO : 508-651-0900 11 MERCER RD. SE DECISION MADE: 16-MAR-05 NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCU-CHEK SPIRIT DISETRONIC MEDICAL SYSTEMS AG 510(k) NO: K042887(TRADITIONAL)
ATTN: SCOTT THIEL PHONE NO : 800-428-5074 9115 HAGUE ROAD SE DECISION MADE: 18-MAR-05 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRAGON HEART I.V. SET DRAGON HEART MEDICAL DEVICES CO., 510(k) NO: K043235(ABBREVIATED)
ATTN: JINA YU PHONE NO : 630-833-6998 188 INDUSTRIAL DRIVE SE DECISION MADE: 08-MAR-05 SUITE 108 510(k) STATEMENT ELMHURST, IL 60126 DEVICE: MINIMASTER ULTRASONIC SCALER E.M.S. ELECTRO MEDICAL SYSTEMS S.A510(k) NO: K050710(SPECIAL)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 30-MAR-05 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFESTENT TURBO BILIARY STENT SYSTEMS EDWARDS LIFESCIENCES, LLC. 510(k) NO: K050627(SPECIAL)
ATTN: KEVIN DRISKO PHONE NO : 949-250-2416 ONE EDWARDS WAY SE DECISION MADE: 22-MAR-05 IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LYSUS INFUSION SYSTEM EKOS CORP. 510(k) NO: K050472(SPECIAL)
ATTN: JOCELYN KERSTEN PHONE NO : 425-482-1108 22030 20TH AVENUE S.E. SE DECISION MADE: 11-MAR-05 SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA BOTHELL, WA 98021 DEVICE: EKOS PERIPHERAL INFUSION SYSTEM EKOS CORP. 510(k) NO: K050563(SPECIAL)
ATTN: JOCELYN KERSTEN PHONE NO : 425-482-1108 22030 20TH AVENUE S.E. SE DECISION MADE: 29-MAR-05 SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA BOTHELL, WA 98021 DEVICE: K-LASER, MODELS 3,4,4D,6D ELTECH, S.R.L. 510(k) NO: K050070(TRADITIONAL)
ATTN: RICHARD ALBRIGHT PHONE NO : 615-595-7749 1510 TOWNE PARK LANE SE DECISION MADE: 25-MAR-05 FRANKLIN, TN 37067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENCORE REVERSE SHOULDER PROSTHESIS ENCORE MEDICAL, L.P. 510(k) NO: K041066(TRADITIONAL)
ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-834-6237 9800 METRIC BLVD. SE DECISION MADE: 24-MAR-05 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, ENTER MEDICAL CORPORATION 510(k) NO: K042556(TRADITIONAL)
ATTN: TZONG-FUH KUO PHONE NO : 886 332 83653 NO.16-1, LANE 564 SE DECISION MADE: 11-MAR-05 WEN HUA SAN ROAD 510(k) SUMMARY AVAILABLE FROM FDA GUI SHAN XIANG,TAO YUAN HSIEN, CHINA (TAIWAN) 333 DEVICE: FLEXIBLE SPINAL NEEDLE EPIMED INTERNATIONAL, INC. 510(k) NO: K043467(TRADITIONAL)
ATTN: CHRISTOPHER LAKE PHONE NO : 518-725-0209 141 SAL LANDRIO DR. SE DECISION MADE: 31-MAR-05 CROSSROADS BUSINESS PARK 510(k) SUMMARY AVAILABLE FROM FDA JOHNSTOWN, NY 12095 DEVICE: LIGACLIP 5 M/L MM ENDOSCOPIC MULTIPLE CLIP APPLIER ETHICON ENDO SURGERY, INC. 510(k) NO: K050344(TRADITIONAL)
ATTN: KIMBERLY SHOEMAKER PHONE NO : 513-337-8123 4545 CREEK ROAD SE DECISION MADE: 14-MAR-05 CINCINNATI, OH 45242 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BENEPHIT BIFURCATED INFUSION CATHETER AND 5FR. INTRODUCER SHEATH FLOWMEDICA, INC. 510(k) NO: K050205(SPECIAL)
ATTN: JEFF ELKINS PHONE NO : 510-252-9500 46563 FREMONT BLVD. SE DECISION MADE: 04-MAR-05 FREMONT, CA 94538 510(k) STATEMENT DEVICE: POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A FOREMOUNT ENT. CO., LTD. 510(k) NO: K042727(TRADITIONAL)
ATTN: TYSON HSU PHONE NO : 886 4 25605508 9F-4, NO.1 LANE 641 SE DECISION MADE: 18-MAR-05 SHEN-LIN SOUTH RD. 510(k) SUMMARY AVAILABLE FROM FDA TA YA HSIANG, TAICHUNG, CHINA (TAIWAN) 428 DEVICE: FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS X FOTONA D.D. 510(k) NO: K050293(TRADITIONAL) ATTN: STOJAN TROST PHONE NO : 386 150 09299 STEGNE 7, SE DECISION MADE: 18-MAR-05 LJUBLJANA, SLOVENIA 1210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRESENIUS LIBERTY CYCLER FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K043363(TRADITIONAL)
ATTN: ARTHUR EILINSFELD PHONE NO : 781-402-9068 95 HAYDEN AVE. SE DECISION MADE: 31-MAR-05 LEXINGTON, MA 02420-9192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS GAMBRO RENAL PRODUCTS 510(k) NO: K042797(ABBREVIATED)
ATTN: ROD J RYLANDS PHONE NO : 303-542-5075 10810 WEST COLLINS AVE. SE DECISION MADE: 09-MAR-05 LAKEWOOD, CO 80215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABILITY POWER GURNEY GATOR CUSTOM MOBILITY, INC. 510(k) NO: K042699(TRADITIONAL)
ATTN: GREGORY S SIMS PHONE NO : 352-373-9673 501 NE 23RD AVE. SE DECISION MADE: 16-MAR-05 GAINESVILLE, FL 32609 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUSION PUTTY TYPE GC AMERICA, INC. 510(k) NO: K043493(TRADITIONAL)
ATTN: TERRY JORITZ PHONE NO : 708-926-3105 3737 WEST 127TH ST. SE DECISION MADE: 04-MAR-05 ALSIP, IL 60803 510(k) STATEMENT DEVICE: GE DISCOVERY VCT SYSTEM GE MEDICAL SYSTEMS 510(k) NO: K050559(TRADITIONAL)
ATTN: D DUERSTELER PHONE NO : 262-312-7029 3000 NORTH GRANDVIEW BLVD. SE DECISION MADE: 17-MAR-05 W-400 510(k) SUMMARY AVAILABLE FROM FDA WAUKESHA, WI 53188 THIRD PARTY REVIEW DEVICE: INNOVA 2100 GE MEDICAL SYSTEMS, LLC 510(k) NO: K050489(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894 3000 N. GRANDVIEW BLVD. SE DECISION MADE: 11-MAR-05 WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE GEN-PROBE, INC. 510(k) NO: K043144(TRADITIONAL) ATTN: ALAN MADERAZO PHONE NO : 858-410-8332 10210 GENETIC CENTER DR. SE DECISION MADE: 14-MAR-05 SAN DIEGO, CA 92121-4362 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110- GENDEX DENTAL SYSTEMS 510(k) NO: K050255(TRADITIONAL)
ATTN: JOHN R MILLER PHONE NO : 847-640-4924 901 WEST OAKTON ST. SE DECISION MADE: 17-MAR-05 DES PLAINES, IL 60018-1884 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: V-BAG WITH GBS COATING GISH BIOMEDICAL, INC. 510(k) NO: K050195(TRADITIONAL)
ATTN: J. HARVEY KNAUSS PHONE NO : 832-285-9423 11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 17-MAR-05 HOUSTON, TX 77071 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRISMATIK CERAMIC GLIDEWELL LABORATORIES 510(k) NO: K050144(TRADITIONAL)
ATTN: KEITH D ALLRED PHONE NO : 949-440-2683 4141 MACARTHUR BLVD. SE DECISION MADE: 03-MAR-05 NEWPORT BEACH, CA 92660 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLOBAL TREASURES FLUID FILLED TEETHER GLOBAL TREASURE INDUSTRIES LTD. 510(k) NO: K043033(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808 163 CABOT ST. SE DECISION MADE: 22-MAR-05 BEVERLY, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GOCANNING GLS-700 E-PULSE ANALYSIS MONITOR GOCANNING TECHNOLOGY LTD. 510(k) NO: K043352(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-9488 3892 SOUTH AMERICA WEST TRAIL SE DECISION MADE: 31-MAR-05 FLAGGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GYRUS PLASMA SKIN RESURFACING SYSTEM GYRUS MEDICAL, INC. 510(k) NO: K041999(TRADITIONAL)
ATTN: MARK JENSEN PHONE NO : 763-416-3005 6655 WEDGWOOD ROAD, SUITE 160 SE DECISION MADE: 02-MAR-05 MAPLE GROVE, MN 55311-3602 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENTILAIR II MEDICAL AIR COMPRESSOR HAMILTON MEDICAL AG 510(k) NO: K041781(TRADITIONAL)
ATTN: J. DAVID THOMPSON PHONE NO : 775-858-3200 PO BOX 30008 SE DECISION MADE: 14-MAR-05 RENO, NV 89502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) HARTALEGA SDN BHD 510(k) NO: K050214(TRADITIONAL)
ATTN: KUAN EU JIN PHONE NO : 603 627 42177 LOT 9, JALAN KUANG BULAN,TAMAN SE DECISION MADE: 16-MAR-05 KEPONG IND. ESTATE 510(k) STATEMENT SELANGOR, DARUL EHSAN, MALAYSIA 52100 DEVICE: NITRILE POWDERED EXAMINATION GLOVES (WHITE) HARTALEGA SDN BHD 510(k) NO: K050215(TRADITIONAL)
ATTN: KUAN EU JIN PHONE NO : 603 627 42177 LOT 9, JALAN KUANG BULAN,TAMAN SE DECISION MADE: 11-MAR-05 KEPONG IND. ESTATE 510(k) STATEMENT SELANGOR, DARUL EHSAN, MALAYSIA 52100 DEVICE: HARVEST GRAFT DELIVERY SYRINGE HARVEST TECHNOLOGIES, CORP. 510(k) NO: K043261(TRADITIONAL)
ATTN: JACK BONASERA PHONE NO : 508-732-7500 40 GRISSOM RD, SUITE 100 SE DECISION MADE: 11-MAR-05 PLYMOUTH, MA 02360 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HL168JP HEALTH & LIFE CO., LTD. 510(k) NO: K050249(SPECIAL)
ATTN: PAUL HUNG PHONE NO : 886 282 271300 9F, NO.186, JIAN YI ROAD SE DECISION MADE: 30-MAR-05 CHUNG HO CITY, TAIPEI, CHINA (TAIW510(k) STATEMENT DEVICE: H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888 HEALTH & LIFE CO., LTD. 510(k) NO: K050491(SPECIAL)
ATTN: PAUL HUNG PHONE NO : 886 2 82271300 9F, NO.186, JIAN YI ROAD SE DECISION MADE: 31-MAR-05 CHUNG HO CITY, TAIPEI, CHINA (TAIW510(k) STATEMENT DEVICE: TRIFIT 700 HEALTHFIRST CORP. 510(k) NO: K033646(TRADITIONAL)
ATTN: JAY SKOLNIK PHONE NO : 505-299-1157 13170-B CENTRAL AVE SE SE DECISION MADE: 01-MAR-05 SUITE 115 510(k) SUMMARY AVAILABLE FROM FDA ALBUQUERQUE, NM 87123 DEVICE: PRESS TACK/INTRADERMAL ACUPUNCTURE NEEDLES HELIO MEDICAL SUPPLIES, INC. 510(k) NO: K050295(TRADITIONAL)
ATTN: ERIC CHENG PHONE NO : 408-433-3355 606 CHARCOT AVE. SE DECISION MADE: 25-MAR-05 SAN JOSE, CA 95131 510(k) STATEMENT DEVICE: HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE HENKE SASS WOLF OF AMERICA, INC. 510(k) NO: K050163(TRADITIONAL)
ATTN: LYNETTE HOWARD PHONE NO : 908-788-4580 203 MAIN STREET, PMB 166 SE DECISION MADE: 24-MAR-05 FLEMINGTON, NJ 08822 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOFFMAN II MICRO EXTERNAL FIXATION SYSTEM HOWMEDICA OSTEONICS CORP 510(k) NO: K050048(TRADITIONAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581 325 CORPORATE DR. SE DECISION MADE: 04-MAR-05 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIZE 1 TRIATHLON POSTERIOR STABILIZED (PS) TIBIAL INSERT HOWMEDICA OSTEONICS CORP 510(k) NO: K050539(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718 325 CORPORATE DR. SE DECISION MADE: 29-MAR-05 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: RESTORATION MODULAR SYSTEM HOWMEDICA OSTEONICS CORP. 510(k) NO: K050138(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718 325 CORPORATE DRIVE SE DECISION MADE: 21-MAR-05 MAHWAH, NJ 07430 510(k) STATEMENT DEVICE: STRYKER LOCKED PLATING SYSTEM HOWMEDICA OSTEONICS CORP. 510(k) NO: K050512(TRADITIONAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581 325 CORPORATE DRIVE SE DECISION MADE: 21-MAR-05 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL FOREHEAD THERMOMETER, MODEL FS-100 HUBDIC CO., LTD 510(k) NO: K043331(TRADITIONAL)
ATTN: GUENTER GINSBERG PHONE NO : 239-948-2001 11820 RED HIBISCUS DR. SE DECISION MADE: 04-MAR-05 BONITA SPRINGS, FL 34135 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA HYCOR BIOMEDICAL LTD. 510(k) NO: K043433(TRADITIONAL)
ATTN: DANIELLE M KNIGHT PHONE NO : 44 131 4457111 PENTLANDS SCIENCE PARK SE DECISION MADE: 07-MAR-05 BUSH LOAN 510(k) SUMMARY AVAILABLE FROM FDA EDINBURGH, UNITED KINGDOM EH26 OPL DEVICE: BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIB HYPHEN BIOMED 510(k) NO: K043451(ABBREVIATED)
ATTN: OLA ANDERSON PHONE NO : 513-779-2899 9944 BENNINGTAN DRIVE SE DECISION MADE: 17-MAR-05 CINCINNATI, OH 45241 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100 HYPOGUARD USA, INC. 510(k) NO: K041881(TRADITIONAL)
ATTN: BRUCE A MACFARLANE PHONE NO : 952-646-3188 5182 WEST 76TH ST. SE DECISION MADE: 25-MAR-05 MINNEAPOLIS, MN 55439 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL100600 IDEV TECHNOLOGIES, INC. 510(k) NO: K041374(TRADITIONAL)
ATTN: LYNNE A DAVIES PHONE NO : 281-333-1998 1110 NASA RD., SUITE 311 SE DECISION MADE: 02-MAR-05 HOUSTON, TX 77058-3345 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CELLTRACKA ANALYZER II IMMUNICON CORP. 510(k) NO: K050145(TRADITIONAL)
ATTN: PETER SCOTT PHONE NO : 215-830-0777 3401 MASONS MILL RD. STE 100 SE DECISION MADE: 15-MAR-05 HUNTINGDON VALLEY, PA 19006-3574 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: INION OTPS BIODEGRADABLE PIN INION LTD. 510(k) NO: K050275(SPECIAL)
ATTN: HANNA MARTTILA PHONE NO : 358 323 06600 LAAKARINKATU 2 SE DECISION MADE: 07-MAR-05 TAMPERE, FINLAND 33520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MPS (OR MPS-T) INNERSPACE, INC. 510(k) NO: K041838(TRADITIONAL)
ATTN: DONALD E BOBO PHONE NO : 949-752-8672 2933 SOUTH PULLMAN ST., SE DECISION MADE: 01-MAR-05 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA SANTA ANA, CA 92705 DEVICE: SUREFLEX AND ACCUFLEX LASER LITHOTRIPSY FIBERS INNOVAQUARTZ 510(k) NO: K050108(TRADITIONAL)
ATTN: STEVE GRIFFIN PHONE NO : 623-434-1895 23030 NORTH 15TH AVE. SE DECISION MADE: 14-MAR-05 PHOENIX, AZ 85027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ISIS MER SYSTEM/ELEKTA MER SYSTEM INOMED MEDIZINTECHNIK GMBH 510(k) NO: K042208(TRADITIONAL)
ATTN: ANDERS SKOGLUND PHONE NO : 468 587 25400 KUNGSTENSGATAN 18, PO BX 7593 SE DECISION MADE: 18-MAR-05 STOCKHOLM, GERMANY SE-103 93 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMOSIL SILICA CLOTTING TIME INSTRUMENTATION LABORATORY CO. 510(k) NO: K050221(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467 113 HARTWELL AVE. SE DECISION MADE: 30-MAR-05 LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMOSIL D-DIMER INSTRUMENTATION LABORATORY CO. 510(k) NO: K050278(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467 113 HARTWELL AVE. SE DECISION MADE: 10-MAR-05 LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104 INTEGRA LIFESCIENCES CORP. 510(k) NO: K050319(TRADITIONAL)
ATTN: CHARLES E DINKLER II PHONE NO : 513-533-7941 4900 CHARLEMAR DRIVE, SE DECISION MADE: 31-MAR-05 BUILDING A 510(k) SUMMARY AVAILABLE FROM FDA CINCINATTI, OH 45227 DEVICE: INTEGRA BONE FIXATION SYSTEM INTEGRA LIFESCIENCES CORP. 510(k) NO: K050492(SPECIAL)
ATTN: DONNA WALLACE PHONE NO : 609-936-2397 311 ENTERPRISE DR. SE DECISION MADE: 14-MAR-05 PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNDER BUTTOCKS DRAPE INTERNATIONAL MEDSURG CONNECTION, 510(k) NO: K042893(TRADITIONAL)
ATTN: TEODORO SANTIAGO PHONE NO : 414-861-2178 PO BOX 100624 SE DECISION MADE: 11-MAR-05 CUDAHY, WI 53110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND INTUITIVE SURGICAL, INC. 510(k) NO: K043288(TRADITIONAL)
ATTN: USHA KREADEN PHONE NO : 408-523-4150 950 KIFER RD. SE DECISION MADE: 03-MAR-05 SUNNYVALE, CA 94086-5206 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIVER C.E. CATHETER INVATEC INNOVATIVE TECHNOLOGIES, S510(k) NO: K050276(TRADITIONAL)
ATTN: PATRICE STROMBERG PHONE NO : 763-398-7487 4600 NATHAN LANE NORTH SE DECISION MADE: 07-MAR-05 PLYMOUTH, MN 55442 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MRIDIUM 3850 MRI PUMP SYSTEM IRADIMED CORPORATION 510(k) NO: K050301(TRADITIONAL)
ATTN: FRANCIS X CASEY PHONE NO : 407-677-8022 7457 ALOMA AVENUE SE DECISION MADE: 24-MAR-05 SUITE 201 510(k) SUMMARY AVAILABLE FROM FDA WINTER PARK, FL 32792 THIRD PARTY REVIEW DEVICE: IQ 200 URINE ANALYZER BODY FLUIDS MODULE IRIS INTERNATIONAL, INC. 510(k) NO: K050235(TRADITIONAL)
ATTN: HARVEY L KASDAN PHONE NO : 818-709-1244 9172 ETON AVE. SE DECISION MADE: 23-MAR-05 CHATSWORTH, CA 91311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYNAGRAFT II ISOTIS ORTHOBIOLOGICS, INC 510(k) NO: K040419(TRADITIONAL)
ATTN: ELIANE SCHUTTE PHONE NO : 31 030 2995253 PROF. BRONKHORSTLAAN 10-D SE DECISION MADE: 25-MAR-05 P.O. BOX 98 510(k) SUMMARY AVAILABLE FROM FDA BILTHOVEN, NETHERLANDS 3723 MB DEVICE: AIR SOLFY, MODELS AS-4H, AS-4H-O, AS-4H-V, AS-4H-OV, AS-1,AS-1-0 J. MORITA USA, INC. 510(k) NO: K043497(TRADITIONAL)
ATTN: KEITH A BARRITT PHONE NO : 202-783-5070 1425 K ST. N.W. SE DECISION MADE: 21-MAR-05 11TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20005 DEVICE: YIXIN SAFETY SYRINGE JIANGXI SANXIN (EVERSINCERE) MEDIC510(k) NO: K042102(TRADITIONAL)
ATTN: LIU KUN SHENG PHONE NO : 86 079 15101888 SHAN JIANG ZHEN ROAD SE DECISION MADE: 08-MAR-05 NAN CHANG, JIANGXI, CHINA 330204 510(k) STATEMENT DEVICE: TRIACTIV SYSTEM KENSEY NASH CORP. 510(k) NO: K042040(TRADITIONAL)
ATTN: ROBIN M FATZINGER PHONE NO : 610-524-0188 55 EAST UWCHLAN AVE. SE DECISION MADE: 23-MAR-05 MARSH CREEK CORP. CENTER 510(k) SUMMARY AVAILABLE FROM FDA EXTON, PA 19341-1247 DEVICE: FEATHERLIFT EXTENDED APTOS THREAD KMI KOLSTER METHODS, INC. 510(k) NO: K043591(TRADITIONAL)
ATTN: KEITH DAVIS PHONE NO : 951-737-5476 3185 PALISADES DR. SE DECISION MADE: 04-MAR-05 CORONA, CA 92882 510(k) STATEMENT DEVICE: KD-575 MEMORY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR KODON(TIANJIN)ELECTRONIC&ELECTRICA510(k) NO: K042418(TRADITIONAL)
ATTN: LIU YI PHONE NO : 86 22 60526082 NO.31, CHANGJIANG ROAD, SE DECISION MADE: 21-MAR-05 NANKAI DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA TIANJIN, CHINA 300193 DEVICE: LAZRPULSR 4X LED HEALING LIGHT LLC 510(k) NO: K041565(TRADITIONAL)
ATTN: MICHAEL B KINDER PHONE NO : 303-520-2905 1276 CHAMBERS ROAD SE DECISION MADE: 03-MAR-05 AURORA, CO 80017 510(k) STATEMENT DEVICE: TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 520 LINDE MEDICAL SENSORS AG 510(k) NO: K043357(TRADITIONAL)
ATTN: JEAN-PIERRE PALMA PHONE NO : 011 41 612788207 AUSTRASSE 25 SE DECISION MADE: 04-MAR-05 BASEL, SWITZERLAND 4051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER LINVATEC CORP. 510(k) NO: K050227(SPECIAL)
ATTN: ELIZABETH M PAUL PHONE NO : 727-399-5234 11311 CONCEPT BLVD. SE DECISION MADE: 02-MAR-05 LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET LINVATEC CORP. 510(k) NO: K050497(SPECIAL)
ATTN: ELIZABETH PAUL PHONE NO : 727-399-5234 11311 CONCEPT BLVD. SE DECISION MADE: 25-MAR-05 LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM LUMENIS, INC. 510(k) NO: K050639(SPECIAL)
ATTN: MARTHA MURARI PHONE NO : 408-764-3604 2400 CONDENSA ST. SE DECISION MADE: 31-MAR-05 SANTA CLARA, CA 95051-0901 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS MAINE STANDARDS CO. 510(k) NO: K050504(TRADITIONAL)
ATTN: CHIRSTINE BEACH PHONE NO : 207-892-1300 765 ROOSEVELT TRAIL SE DECISION MADE: 25-MAR-05 WINDHAM, ME 04062-5365 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C-CO2 COLORIMETRIC CO2 INDICATOR MARQUEST MEDICAL PRODUCTS, INC. 510(k) NO: K050066(TRADITIONAL)
ATTN: THOMAS W DIELMANN PHONE NO : 303-790-4835 11039 EAST LANSING CIR. SE DECISION MADE: 01-MAR-05 ENGLEWOOD, CO 80112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MS-930 MARS INFLATE-READ BLOOD PRESSURE MONITOR MARS MEDICAL PRODUCTS 510(k) NO: K050039(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 410-451-0639 P.O. BOX 4341 SE DECISION MADE: 25-MAR-05 CROFTON, MD 21114 510(k) STATEMENT DEVICE: MS-753 MARS INFLATE-READ BLOOD PRESSURE MONITOR MARS MEDICAL PRODUCTS 510(k) NO: K050040(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 410-451-0639 P.O. BOX 4341 SE DECISION MADE: 30-MAR-05 CROFTON, MD 21114 510(k) STATEMENT DEVICE: VISITRAK, VERSION 1, RELEASE 1 MATH RESOLUTIONS, LLC. 510(k) NO: K050372(TRADITIONAL)
ATTN: WENDEL DEAN RENNER PHONE NO : 410-997-9578 5975 GALES LN. SE DECISION MADE: 25-MAR-05 COLUMBIA, MD 21045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMOCATH MED-CONDUIT, INC. 510(k) NO: K043292(TRADITIONAL)
ATTN: ROBERT W CUNNINGHAM PHONE NO : 617-750-1889 18 DERBY LANE SE DECISION MADE: 16-MAR-05 TYNGSBORO, MA 01879 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410 MEDICOMP, INC. 510(k) NO: K043454(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502 55 NORTHERN BLVD. SE DECISION MADE: 24-MAR-05 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES MEDLINE INDUSTRIES, INC. 510(k) NO: K032666(TRADITIONAL)
ATTN: LARA SIMMONS PHONE NO : 847-578-6072 1170 S. NORTHPOINT BLVD. SE DECISION MADE: 16-MAR-05 WAUKEGAN, IL 60085 510(k) STATEMENT DEVICE: PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS MEDLINE INDUSTRIES, INC. 510(k) NO: K043017(TRADITIONAL)
ATTN: LARA N SIMMONS PHONE NO : 847-578-6072 1170 S. NORTHPOINT BLVD. SE DECISION MADE: 08-MAR-05 WAUKEGAN, IL 60085 510(k) STATEMENT DEVICE: MEDLINE SURGICAL GOWNS MEDLINE INDUSTRIES, INC. 510(k) NO: K043585(TRADITIONAL)
ATTN: LARA N SIMMONS PHONE NO : 847-578-6072 1170 NORTHPOINT BLVD. SE DECISION MADE: 08-MAR-05 WAUKEGAN, IL 60085 510(k) STATEMENT DEVICE: UNISCAN, PULMOSCAN, PULMOSCAN RADIOGRAPHIC SYSTEMS MEDLINK IMAGING 510(k) NO: K033577(ABBREVIATED)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727 P.O. BOX 7007 SE DECISION MADE: 18-MAR-05 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GS-128 GRADIENT COMPRESSION SYSTEM MEDMARK TECHNOLOGIES, LLC 510(k) NO: K050584(TRADITIONAL)
ATTN: MARK HIGGINS PHONE NO : 215-249-1540 724H WEST RT 313 SE DECISION MADE: 22-MAR-05 PERKASIE, PA 18944 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C MEDTRONIC MINIMED 510(k) NO: K043600(TRADITIONAL)
ATTN: GERDA P RESCH PHONE NO : 818-576-4198 18000 DEVONSHIRE ST. SE DECISION MADE: 29-MAR-05 NORTHRIDGE, CA 91325-1219 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K043488(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 21-MAR-05 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K050439(SPECIAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PL. SE DECISION MADE: 24-MAR-05 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE MEDTRONIC XOMED, INC. 510(k) NO: K050162(TRADITIONAL)
ATTN: DAVID S DODD PHONE NO : 904-332-8746 6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 03-MAR-05 JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: EXPORT CATHETER MEDTRONIC, INC. 510(k) NO: K050139(SPECIAL)
ATTN: FRED L BOUCHER PHONE NO : 978-777-0042 35-37A CHERRY HILL DR. SE DECISION MADE: 22-MAR-05 DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEGA POWER ELECTROSURGICAL GENERATOR MEGADYNE MEDICAL PRODUCTS, INC. 510(k) NO: K050579(TRADITIONAL)
ATTN: RONDA K MAGNESON PHONE NO : 801-576-9669 11506 SOUTH STATE ST. SE DECISION MADE: 24-MAR-05 DRAPER, UT 84020 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT MENTOR CORPORATION 510(k) NO: K050148(TRADITIONAL)
ATTN: DONNA CRAWFORD PHONE NO : 805-879-6304 201 MENTOR DRIVE SE DECISION MADE: 09-MAR-05 SANTA BARBARA, CA 93111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEM MERETE MEDICAL GMBH 510(k) NO: K050457(TRADITIONAL)
ATTN: JENIK RADON PHONE NO : 212-496-2700 269 WEST SEVENTY-FIRST STREET SE DECISION MADE: 14-MAR-05 NEW YORK, NY 10023 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMUNOCARD STAT! FLU A & B MERIDIAN BIOSCIENCE, INC. 510(k) NO: K041626(TRADITIONAL)
ATTN: SUSAN ROLIH PHONE NO : 513-271-3700 3471 RIVER HILLS DR. SE DECISION MADE: 16-MAR-05 CINCINNATI, OH 45244 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CEDIA TACROLIMUS ASSAY MICROGENICS CORP. 510(k) NO: K050206(TRADITIONAL)
ATTN: LISA CHARTER PHONE NO : 510-979-5142 46360 FREMONT BLVD. SE DECISION MADE: 15-MAR-05 FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MILTEX LAPAROSCOPIC INSTRUMENTS MILTEX, INC. 510(k) NO: K043013(TRADITIONAL)
ATTN: CHARLES WEAVER PHONE NO : 717-840-9335 589 DAVIES DRIVE SE DECISION MADE: 04-MAR-05 YORK, PA 17402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOONCUP, STYLE A & B MOONCUP LLC 510(k) NO: K040335(TRADITIONAL)
ATTN: MORRIS WAXLER PHONE NO : 608-284-2638 ONE EAST MAIN STREET SE DECISION MADE: 30-MAR-05 MADISON, WI 53701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4 MORE DIAGNOSTICS 510(k) NO: K050125(TRADITIONAL)
ATTN: JAMES W SNIPES PHONE NO : 805-528-6005 2020 11TH ST. SE DECISION MADE: 18-MAR-05 LOS OSOS, CA 93402 510(k) STATEMENT DEVICE: EPI-K MORIA S.A. 510(k) NO: K043183(TRADITIONAL)
ATTN: ELANIE RENAUD-SAMIRI PHONE NO : 33 1 46744636 15 RUE GEORGES BESSE SE DECISION MADE: 25-MAR-05 ANTONY, FRANCE 92160 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS MRI DEVICES CORPORATION 510(k) NO: K050514(TRADITIONAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402 N27 W23676 PAUL RD SE DECISION MADE: 25-MAR-05 PEWAUKEE, WI 53072 510(k) STATEMENT DEVICE: DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K040262(TRADITIONAL)
ATTN: KATHLEEN M LAFFAN PHONE NO : 732-661-2129 125 MAY ST SE DECISION MADE: 17-MAR-05 EDISON, NJ 08837 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE NEO METRICS, INC. 510(k) NO: K043398(SPECIAL)
ATTN: GENE CHAMPEAU PHONE NO : 763-559-4440 14800 28TH AVENUE NORTH SE DECISION MADE: 01-MAR-05 SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA PLYMOUTH, MN 55447 DEVICE: NEO IMPLANT SYSTEM NEOSS LTD 510(k) NO: K043195(TRADITIONAL)
ATTN: RUSSELL PAGANO PHONE NO : 202-546-1262 719 A STREET NE SE DECISION MADE: 07-MAR-05 WASHINGTON, DC 20002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEOTHERMIA EN-BLOC BIOPSY SYSTEM NEOTHERMIA CORPORATION 510(k) NO: K050737(SPECIAL)
ATTN: DAVID JACOBS PHONE NO : 508-655-7820 ONE APPLE HILL SUITE 316 SE DECISION MADE: 31-MAR-05 NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STABILIZATION SCREW NEWDEAL S.A. 510(k) NO: K050346(TRADITIONAL)
ATTN: JUDITH E O'GRADY PHONE NO : 609-936-2247 311 ENTERPRISE DRIVE SE DECISION MADE: 17-MAR-05 PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL DS-1901 DIGITAL BLOOD PRESSURE MONITOR NIHON SEIMITSU SOKKI CO., LTD. 510(k) NO: K050697(TRADITIONAL)
ATTN: LYNETTE HOWARD PHONE NO : 908-788-4580 203 MAIN STREET, 166 SE DECISION MADE: 25-MAR-05 FLEMINGTON, NJ 08822 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC NOBLE FIBER TECHNOLOGIES, INC. 510(k) NO: K043526(TRADITIONAL) ATTN: PATRICIA DAVIDSON PHONE NO : 877-978-2842 421 SOUTH STATE ST. SE DECISION MADE: 10-MAR-05 CLARKS SUMMIT, PA 18411 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIASYS INTEGRA II NOVACOR FRANCE 510(k) NO: K042109(TRADITIONAL)
ATTN: DOMINIQUE GRENIER PHONE NO : 4, PASSAGE SAINT ANTOINE SE DECISION MADE: 09-MAR-05 RUEIL MALMAISON CEDEX, FRANCE 9250510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOLINK TRUE MOVEMENT SYSTEM NOVARE SURGICAL SYSTEMS, INC. 510(k) NO: K043541(TRADITIONAL)
ATTN: GREGORY MATHISON PHONE NO : 218-387-1559 3924 CASCADE BEACH ROAD SE DECISION MADE: 10-MAR-05 LUTSEN, MN 55612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVOFINE AUTOCOVER 30G X 8MM NOVO NORDISK, INC. 510(k) NO: K050106(TRADITIONAL)
ATTN: JOHN SIGNORIN PHONE NO : 609-987-5800 100 COLLEGE ROAD WEST SE DECISION MADE: 30-MAR-05 PRINCETON, NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001 NUCLETRON CORP. 510(k) NO: K041715(TRADITIONAL)
ATTN: LISA DIMMICK PHONE NO : 410-872-4435 8671 ROBERT FULTON DRIVE SE DECISION MADE: 24-MAR-05 COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 NXSTAGE MEDICAL, INC. 510(k) NO: K043436(TRADITIONAL)
ATTN: NORMA LEMAY PHONE NO : 978-687-4700 439 SOUTH UNION ST. SE DECISION MADE: 17-MAR-05 SUITE 501 510(k) SUMMARY AVAILABLE FROM FDA LAWRENCE, MA 01843 DEVICE: STARSHIELD V3 RF TRNT ODIN MEDICAL TECHNOLOGIES LTD. 510(k) NO: K050237(SPECIAL)
ATTN: ADI ICKOWICZ PHONE NO : 972 495 91010 P.O BOX 548 SE DECISION MADE: 18-MAR-05 YOKNEAM ELIT, ISRAEL 20692 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01 OPTIMEDICA CORPORATION 510(k) NO: K043486(TRADITIONAL)
ATTN: JUDY GORDON PHONE NO : 949-854-6314 2 DELPHINUS SE DECISION MADE: 03-MAR-05 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSSAPLAST ORTHO OSSACUR AG 510(k) NO: K050416(ABBREVIATED)
ATTN: KRISTI KISTNER PHONE NO : 805-682-8685 975 VERONICS SPRINGS ROAD SE DECISION MADE: 29-MAR-05 SANTA BARBARA, CA 93105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OXYBAND WOUND DRESSING OXYBAND TECHNOLOGIES, INC. 510(k) NO: K043063(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245 5 TIMBER LANE SE DECISION MADE: 24-MAR-05 NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMNILUX PLUS PHOTO THERAPEUTICS LIMITED 510(k) NO: K043317(TRADITIONAL)
ATTN: STEVEN G HUTSON PHONE NO : 441 619 255615 STATION HOUSE SE DECISION MADE: 15-MAR-05 STAMFORD NEW ROAD 510(k) SUMMARY AVAILABLE FROM FDA ALTRINCHAM, CHESHIRE, UNITED KINGDOM WA14 1EP DEVICE: OMNILUX REVIVE AND BLUE PHOTO THERAPEUTICS LIMITED 510(k) NO: K043329(TRADITIONAL)
ATTN: STEVE G HUTSON PHONE NO : 441 619 255615 STATION HOUSE SE DECISION MADE: 18-MAR-05 STAMFORD NEW ROAD 510(k) SUMMARY AVAILABLE FROM FDA ALTRINCHAM, CHESHIRE, UNITED KINGDOM WA14 1EP DEVICE: ENDOMARK STERILE INDIA INK PMT CORP. 510(k) NO: K042901(TRADITIONAL)
ATTN: JAMES R VEALE PHONE NO : 719-495-3438 49 PLAIN STREET SE DECISION MADE: 16-MAR-05 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRYOCHECK CLOT S PRECISION BIOLOGIC INC. 510(k) NO: K043571(TRADITIONAL)
ATTN: STEPHEN L DUFF PHONE NO : 902 468 6422 900 WINDMILL RD., SUITE 100 SE DECISION MADE: 18-MAR-05 DARTMOUTH, N.S., CANADA B3B 1P7 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117 PRIME PACIFIC HEALTH INNOVATIONS C510(k) NO: K050112(TRADITIONAL)
ATTN: DELMAR VOGEL PHONE NO : 604 929 7019 8-145 RIVERSIDE DR. SE DECISION MADE: 15-MAR-05 NORTH VANCOUVER, BC, CANADA V7H 1T510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERSONAL WARMING GEL QUALIS, INC. 510(k) NO: K050211(TRADITIONAL)
ATTN: MIKE PETERSON PHONE NO : 515-243-3000 4600 PARK AVE. SE DECISION MADE: 17-MAR-05 DES MOINES, IA 50321 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERSONAL WARMING JELLY QUALIS, INC. 510(k) NO: K050212(TRADITIONAL)
ATTN: MIKE PETERSON PHONE NO : 515-243-3000 4600 PARK AVE. SE DECISION MADE: 17-MAR-05 DES MOINES, IA 50321 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMI QUANTEL MEDICAL 510(k) NO: K043613(TRADITIONAL)
ATTN: ROGER W BARNES PHONE NO : 501-525-8612 342 SUNSET BAY RD. SE DECISION MADE: 24-MAR-05 HOT SPRINGS, AR 71913 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: R2 FAMILY OF IMAGE DISPLAY UNITS WITH R2 UNIFORM DISPLAY SOFTWAR R2 TECHNOLOGY, INC. 510(k) NO: K050667(TRADITIONAL)
ATTN: RICHARD BALL PHONE NO : 408-481-5696 1195 WEST FREMONT AVE. SE DECISION MADE: 29-MAR-05 SUNNYVALE, CA 94087 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TCM40 MONITORING SYSTEM RADIOMETER MEDICAL APS 510(k) NO: K043003(ABBREVIATED)
ATTN: PIERRE PELLETIER PHONE NO : 45 382 73827 AKANDEVEJ 21 SE DECISION MADE: 01-MAR-05 BRONSHOJ, DENMARK DK-2700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO RAVEN BACTERIAL SPORE STRIPS RAVEN BIOLOGICAL LABORATORIES, INC510(k) NO: K050591(SPECIAL)
ATTN: WENDY ROYALTY-HANN PHONE NO : 402-593-0781 8607 PARK DR. SE DECISION MADE: 23-MAR-05 OMAHA, NE 68127 510(k) STATEMENT DEVICE: BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE REGENT MEDICAL AMERICAS, LLC 510(k) NO: K050184(TRADITIONAL)
ATTN: KATHLEEN HARRIS PHONE NO : 678-250-7900 3585 ENGINEERING DR, STE 250 SE DECISION MADE: 16-MAR-05 NORCROSS, GA 30092 510(k) STATEMENT DEVICE: RELIANT LASER II SYSTEM AND ACCESSORIES RELIANT TECHNOLOGIES, INC. 510(k) NO: K042319(TRADITIONAL)
ATTN: HEATHER TANNER PHONE NO : 650-473-0200 260 SHERIDAN AVE., 3DR. FLOOR SE DECISION MADE: 10-MAR-05 PALO ALTO, CA 94306 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESMED MERIDIAN MASK RESMED LTD. 510(k) NO: K050142(SPECIAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238 14040 DANIELSON ST. SE DECISION MADE: 01-MAR-05 POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRA MIRAGE II MASK RESMED LTD. 510(k) NO: K050359(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238 14040 DANIELSON ST. SE DECISION MADE: 16-MAR-05 POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K042523(TRADITIONAL) ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113 353 CORPORATE WOODS PKWY. SE DECISION MADE: 18-MAR-05 VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONLINE DAT PROPOXYPHENE PLUS ROCHE DIAGNOSTICS CORP. 510(k) NO: K043303(TRADITIONAL)
ATTN: KERWIN KAUFMAN PHONE NO : 317-521-7637 9115 HAGUE RD. SE DECISION MADE: 11-MAR-05 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM SALTER LABS 510(k) NO: K040202(TRADITIONAL)
ATTN: DUANE KAZAL PHONE NO : 661-854-3166 100 W. SYCAMORE RD. SE DECISION MADE: 04-MAR-05 ARVIN, CA 93203 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP SGARLATO LABORATORIES, INC. 510(k) NO: K043204(TRADITIONAL)
ATTN: MICHAEL MCDOUGALL PHONE NO : 408-202-9598 2315 SO. BASCOM SE DECISION MADE: 30-MAR-05 QUALITY MANAGEMENT 510(k) SUMMARY AVAILABLE FROM FDA CAMPBELL, CA 95008 DEVICE: TULIP CONDOM SHANGHAI LATEX FACTORY 510(k) NO: K050360(TRADITIONAL)
ATTN: LOU JI PHONE NO : 86 021 55090975 1700 HUANG XING ROAD SE DECISION MADE: 01-MAR-05 SHANGHAI, CHINA 200433 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: POWDER FREE BUTADIENE EXAM GLOVES WITH ALOE, GREEN SHEN WEI (USA), INC. 510(k) NO: K050467(TRADITIONAL)
ATTN: CYNTHIA LIU PHONE NO : 519-429-8692 2845 WHIPPLE RD. SE DECISION MADE: 30-MAR-05 UNION CITY, CA 94587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED YELLOW SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIU SHIJAIZHUANG BRILLIANT OCEAN PLAST510(k) NO: K043478(TRADITIONAL)
ATTN: EMMY TJOENG PHONE NO : 909-591-8855 5445 DANIELS STREET SE DECISION MADE: 09-MAR-05 CHINO, CA 91710 510(k) STATEMENT DEVICE: SOMATOM EMOTION 16 SIEMENS MEDICAL SOLUTION, INC. USA510(k) NO: K050297(SPECIAL)
ATTN: DEBRA PEACOCK PHONE NO : 610-448-1773 51 VALLEY STREAM PKWY. E50 SE DECISION MADE: 01-MAR-05 MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORDLESS COIL SIEMENS MEDICAL SOLUTION, INC. USA510(k) NO: K050476(TRADITIONAL)
ATTN: ANA LADINO PHONE NO : 610-448-1785 51 VALLEY STREAM PKWY. E50 SE DECISION MADE: 25-MAR-05 MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 550 TXT TREATMENT TABLE SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K050422(SPECIAL)
ATTN: KEN NEHMER PHONE NO : 925-602-8011 4040 NELSON AVE. SE DECISION MADE: 18-MAR-05 CONCORD, CA 94520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERIOSCAN ULTRASONIC SCALER SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K050354(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434 49 PLAIN ST. SE DECISION MADE: 21-MAR-05 NORTH ATTLEBORO, MA 02760-4153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW GENESIS II DEEP FLEXION CRUCIATE RETAINING ARTICU SMITH & NEPHEW, INC. 510(k) NO: K041825(SPECIAL)
ATTN: KIM KELLY PHONE NO : 901-399-6566 1450 E. BROOKS RD. SE DECISION MADE: 11-MAR-05 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE SMITH & NEPHEW, INC. 510(k) NO: K042515(ABBREVIATED)
ATTN: JANET JOHNSON AKIL PHONE NO : 901-399-5520 1450 E. BROOKS RD. SE DECISION MADE: 14-MAR-05 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM SOLCO BIOMEDICAL CO., LTD. 510(k) NO: K043578(TRADITIONAL)
ATTN: SAEYOUNG AHN PHONE NO : 301-469-7912 7612 BARNUM ROAD SE DECISION MADE: 07-MAR-05 BETHESDA, MD 20817 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLEUS POWERED WHEELCHAIR, MODEL FAD-2 SOLEUS CHAMP INTERNATIONAL CO., LT510(k) NO: K043511(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 14-MAR-05 HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADHESIVE 1 SOUTHERN DENTAL INDUSTRIES, INC. 510(k) NO: K050331(TRADITIONAL)
ATTN: SAMANTHA J CHEETHAM PHONE NO : 630-238-8300 729 N. ROUTE 83, SUITE 315 SE DECISION MADE: 24-MAR-05 BENSENVILLE, IL 60106 510(k) STATEMENT DEVICE: SPACELABS MEDICAL MULTIPARAMETER MODULE 91496 SPACELABS MEDICAL, INC. 510(k) NO: K050175(SPECIAL)
ATTN: AL VAN HOUDT PHONE NO : 425-657-7200 5150 220TH AVE SE SE DECISION MADE: 04-MAR-05 P.O. BOX 7018 510(k) SUMMARY AVAILABLE FROM FDA ISSAQUAH, WA 98027-7018 DEVICE: SPECTRANETICS LLD CS, MODEL 518-039 SPECTRANETICS CORP. 510(k) NO: K043401(TRADITIONAL)
ATTN: MICHAEL J RYAN PHONE NO : 719-633-8333 96 TALAMINE CT. SE DECISION MADE: 16-MAR-05 COLORADO SPRINGS, CO 80907-5159 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (C SPI GLOVES SDN. BHD. 510(k) NO: K050527(TRADITIONAL)
ATTN: CHOOI FONG CHUN PHONE NO : 605 322 3200 5, PERSIARAN GREENTOWN 8 SE DECISION MADE: 18-MAR-05 GREENTOWN BUSINESS CENTER 510(k) SUMMARY AVAILABLE FROM FDA IPOH 30450, MALAYSIA DEVICE: POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN SPI GLOVES SDN. BHD. 510(k) NO: K050529(TRADITIONAL)
ATTN: CHOOI FONG CHUN PHONE NO : 605 322 3200 5, PERSIARAN GREENTOWN 8 SE DECISION MADE: 16-MAR-05 GREENTOWN BUSINESS CENTER 510(k) SUMMARY AVAILABLE FROM FDA IPOH 30450, MALAYSIA DEVICE: POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHIT SPI GLOVES SDN. BHD. 510(k) NO: K050530(TRADITIONAL)
ATTN: CHOOI FONG CHUN PHONE NO : 605 322 3200 5, PERSIARAN GREENTOWN 8 SE DECISION MADE: 16-MAR-05 GREENTOWN BUSINESS CENTER 510(k) SUMMARY AVAILABLE FROM FDA IPOH 30450, MALAYSIA DEVICE: POWDERED NITRILE EXAMINATION GLOVES (BLUE,WHITE) SPI GLOVES SDN. BHD. 510(k) NO: K050531(TRADITIONAL)
ATTN: CHOOI FONG CHUN PHONE NO : 605 322 3200 5, PERSIARAN GREENTOWN 8 SE DECISION MADE: 18-MAR-05 GREENTOWN BUSINESS CENTER 510(k) SUMMARY AVAILABLE FROM FDA IPOH 30450, MALAYSIA DEVICE: STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER STANBIO LABORATORY 510(k) NO: K042169(TRADITIONAL)
ATTN: KIRK JOHNSON PHONE NO : 830-249-0772 1261 NORTH MAIN ST. SE DECISION MADE: 14-MAR-05 BOERNE, TX 78006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPEL MLR SURGICAL GOWNS STANDARD TEXTILE CO., INC. 510(k) NO: K041541(TRADITIONAL)
ATTN: BRADLEY J BUSHMAN PHONE NO : 513-761-9255 ONE KNOLLCREST DR. SE DECISION MADE: 16-MAR-05 P.O. BOX 371805 510(k) SUMMARY AVAILABLE FROM FDA CINCINNATI, OH 45237-1600 DEVICE: STERILEMED REPROCESSED IVUS IMAGING CATHETER STERILMED, INC. 510(k) NO: K043453(TRADITIONAL)
ATTN: BRUCE LESTER PHONE NO : 763-488-3400 11400 73RD AVE. NORTH, #100 SE DECISION MADE: 01-MAR-05 MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC C STERILMED, INC. 510(k) NO: K043513(TRADITIONAL)
ATTN: BRUCE R LESTER PHONE NO : 763-488-3400 1140O 73RD AVE. NORTH SE DECISION MADE: 01-MAR-05 MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER URETEROSCOPE STRYKER ENDOSCOPY 510(k) NO: K043021(TRADITIONAL)
ATTN: CHRISTOPHER L COOK PHONE NO : 408-754-2288 5900 OPTICAL CT. SE DECISION MADE: 16-MAR-05 SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER FLEXIBLE CYSTONEPHROSCOPE STRYKER ENDOSCOPY 510(k) NO: K043022(TRADITIONAL)
ATTN: CHRISTOPHER L COOK PHONE NO : 408-754-2288 5900 OPTICAL CT. SE DECISION MADE: 15-MAR-05 SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER MMF SCREW STRYKER INSTRUMENTS 510(k) NO: K050535(TRADITIONAL)
ATTN: NATHAN M MIERSMA PHONE NO : 877-534-2464 4100 EAST MILHAM AVE. SE DECISION MADE: 17-MAR-05 KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER SPINE TRIO PS STRYKER SPINE 510(k) NO: K043180(TRADITIONAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145 2 PEARL COURT SE DECISION MADE: 02-MAR-05 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONTOUR NECKLIFT THREADS SURGICAL SPECIALTIES CORP. 510(k) NO: K050247(TRADITIONAL)
ATTN: ELIZABETH LAZARO PHONE NO : 610-404-1000 100 DENNIS DR. SE DECISION MADE: 04-MAR-05 READING, PA 19606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHARPOINT LUKENS BONE WAX SURGICAL SPECIALTIES CORP. 510(k) NO: K050292(TRADITIONAL)
ATTN: ELIZABETH LAZARO PHONE NO : 610-404-1000 100 DENNIS DR. SE DECISION MADE: 09-MAR-05 READING, PA 19606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AURORA SR AND SRA APPLICATOR SYNERON MEDICAL LTD. 510(k) NO: K050452(SPECIAL)
ATTN: AMIR WALDMAN PHONE NO : 972 4 9096200 INDUSTRIAL ZONE SE DECISION MADE: 09-MAR-05 P.O.B. 550 510(k) SUMMARY AVAILABLE FROM FDA YOQNEAM ILLIT, ISRAEL 20692 DEVICE: SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS SYNTHES (USA) 510(k) NO: K042899(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 16-MAR-05 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES (USA) LCP MODULAR FOOT PLATES SYNTHES (USA) 510(k) NO: K050110(TRADITIONAL)
ATTN: KATHY ANDERSON PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 04-MAR-05 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES RAPID RESORBABLE TACK SYSTEM SYNTHES (USA) 510(k) NO: K050204(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 04-MAR-05 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES MANDIBLE EXTERNAL FIXATOR SYNTHES (USA) 510(k) NO: K050378(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 15-MAR-05 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES VECTRA SYSTEM SYNTHES SPINE CO.LP 510(k) NO: K050451(SPECIAL)
ATTN: SUSAN LEWANDOWSKI PHONE NO : 610-719-5712 1302 WRIGHTS LANE EAST SE DECISION MADE: 24-MAR-05 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPLANT LOCATION SOFTWARE, MODEL 0.1.0 TACTILE TECHNOLOGIES, LTD. 510(k) NO: K050341(TRADITIONAL)
ATTN: ZVIKA SLOVIN PHONE NO : 972 894 84740 10 PLAUT ST. SE DECISION MADE: 29-MAR-05 RABIN SCIENTIFIC PARK 510(k) SUMMARY AVAILABLE FROM FDA RECHOVOT, ISRAEL 76122 DEVICE: CLEVER CHEK TD-3213 TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K042795(TRADITIONAL)
ATTN: SHU-MEI WU PHONE NO : 886 266 358080 4F, 88, SEC.1, KWANG FU ROAD SE DECISION MADE: 07-MAR-05 SAN CHUNG, TAIPEI, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TIGER ENDOTRACHEAL TUBES (VARIOUS MODELS AND SIZES) TIGER MEDICAL PRODUCTS LTD 510(k) NO: K041311(ABBREVIATED)
ATTN: JAY MANSOUR PHONE NO : 770-777-4146 1308 MORNINGSIDE PARK DRIVE SE DECISION MADE: 18-MAR-05 ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT REC TISSUE SCIENCE LABORATORIES, PLC 510(k) NO: K050355(SPECIAL)
ATTN: VICTORIA TAYLOR PHONE NO : 678-342-7808 1141 CLARK STREET, SUITE D SE DECISION MADE: 09-MAR-05 COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TITAN DENTAL IMPLANT ATTACHMENT TITAN IMPLANTS, INC. 510(k) NO: K042715(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235 4329 GRAYDON ROAD SE DECISION MADE: 23-MAR-05 SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENSOR MOBILE SM 100 VITAPHONE 1001R REMOS TMS TELEMEDIZINISCHE SYSTEME GMBH 510(k) NO: K050670(TRADITIONAL)
ATTN: TILO BORCHARDT PHONE NO : 49 371 40081122 STADLERSTRASSE 14 SE DECISION MADE: 30-MAR-05 CHEMNITZ, GERMANY 09126 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: AEQUALIS REVERSED SHOULDER PROSTHESIS TORNIER S.A. 510(k) NO: K050316(SPECIAL)
ATTN: MIREILLE LEMERY PHONE NO : 003 347 6613898 161 RUE LAVOISIER SE DECISION MADE: 16-MAR-05 MONTBONNOT, SAINT-ISMIER, FRANCE 3510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TSX-201A AQUILION LB CT SCANNER TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K050458(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000 2441 MICHELLE DR. SE DECISION MADE: 10-MAR-05 P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA TUSTIN, CA 92781-2068 THIRD PARTY REVIEW DEVICE: BASS ANTALGIC-TRAK TRACTION MASTERS, L.L.C. 510(k) NO: K042482(TRADITIONAL)
ATTN: DAVID B BASS PHONE NO : 516-426-9533 9737 NW 65TH WAY SE DECISION MADE: 21-MAR-05 PARKLAND, FL 33076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VAPORMAX TRIMEDYNE, INC. 510(k) NO: K050412(TRADITIONAL)
ATTN: GLENN YEIK PHONE NO : 949-951-3800 15091 BAKE PKWY. SE DECISION MADE: 14-MAR-05 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TUNG FU AIRMATE TENS, VITALITY MODE, TF-DT001 TUNG FU ELECTRIC CO., LTD. 510(k) NO: K042107(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 3 5208829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 09-MAR-05 HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) STATEMENT DEVICE: MODIFICATION TO ORTHODONTIC COMPOSITE BRACKET SYSTEM ULTRADENT PRODUCTS, INC. 510(k) NO: K050730(SPECIAL)
ATTN: TAMMY LAVERY PHONE NO : 801-553-4323 505 WEST 10200 SOUTH SE DECISION MADE: 31-MAR-05 SOUTH JORDAN, UT 84095 510(k) STATEMENT DEVICE: MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEM VALLEY FORGE SCIENTIFIC CORP. 510(k) NO: K050364(SPECIAL)
ATTN: JERRY L MALIS PHONE NO : 610-666-7500 136 GREEN TREE RD. SE DECISION MADE: 09-MAR-05 P.O. BOX 1179 510(k) SUMMARY AVAILABLE FROM FDA OAKS, PA 19456 DEVICE: VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K040751(TRADITIONAL)
ATTN: HEATHER CRAWFORD PHONE NO : 863-683-8680 5307 GREAT OAK DR. SE DECISION MADE: 10-MAR-05 LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K042074(TRADITIONAL)
ATTN: HEATHER CRAWFORD PHONE NO : 863-683-8680 5307 GREAT OAK DR. SE DECISION MADE: 09-MAR-05 LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VANGUARD REPROCESSED ULTRASONIC SCALPEL VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K043225(TRADITIONAL)
ATTN: HEATHER CRAWFORD PHONE NO : 863-683-8680 5307 GREAT OAK DR. SE DECISION MADE: 22-MAR-05 LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K043315(TRADITIONAL)
ATTN: HEATHER CRAWFORD PHONE NO : 863-683-8680 5307 GREAT OAK DR. SE DECISION MADE: 22-MAR-05 LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR AC VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K043594(TRADITIONAL)
ATTN: HEATHER CRAWFORD PHONE NO : 863-683-8680 5307 GREAT OAK DR. SE DECISION MADE: 31-MAR-05 LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MILLENNIUM MULTI-LEAF COLLIMATOR VARIAN MEDICAL SYSTEMS 510(k) NO: K050442(SPECIAL)
ATTN: VY TRAN PHONE NO : 650-424-5731 3100 HANSEN WAY SE DECISION MADE: 23-MAR-05 M/S E-110 510(k) SUMMARY AVAILABLE FROM FDA PALO ALTO, CA 94304-1129 DEVICE: 4D INTEGRATED TREATMENT CONSOLE VARIAN MEDICAL SYSTEMS 510(k) NO: K050479(SPECIAL)
ATTN: VY TRAN PHONE NO : 650-424-5731 3100 HANSEN WAY SE DECISION MADE: 24-MAR-05 M/S E-110 510(k) SUMMARY AVAILABLE FROM FDA PALO ALTO, CA 94304-1129 DEVICE: VISION VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K042956(TRADITIONAL)
ATTN: VY TRAN PHONE NO : 650-424-5731 3100 HANSEN WAY SE DECISION MADE: 11-MAR-05 PALO ALTO, CA 94304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT VASCULAR SOLUTIONS, INC. 510(k) NO: K050021(TRADITIONAL)
ATTN: LINDA BUSKLEIN PHONE NO : 763-656-4217 6464 SYCAMORE COURT NORTH SE DECISION MADE: 18-MAR-05 MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CELLSEARCH CIRCULATING TUMOR CELL KIT VERIDEX, LLC 510(k) NO: K050245(TRADITIONAL)
ATTN: DEBRA J RASMUSSEN PHONE NO : 908-791-2438 33 TECHNOLOGY DR. SE DECISION MADE: 15-MAR-05 PO BOX 4920 510(k) SUMMARY AVAILABLE FROM FDA WARREN, NJ 07059 DEVICE: GRAFTSAVER VESCARE, INC. 510(k) NO: K043515(TRADITIONAL)
ATTN: DAVID WALSH PHONE NO : 978-663-2475 28 COOK ST. SE DECISION MADE: 31-MAR-05 BILLERICA, MA 01821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, VIASYS MEDSYSTEMS 510(k) NO: K043004(TRADITIONAL)
ATTN: STEPHANIE WASIELEWSKI PHONE NO : 847-353-1348 100 CHADDICK DR. SE DECISION MADE: 16-MAR-05 WHEELING, IL 60090 510(k) STATEMENT DEVICE: PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000 VIASYS MEDSYSTEMS 510(k) NO: K050309(TRADITIONAL)
ATTN: STEPHANIE WASIELEWSKI PHONE NO : 847-353-1348 100 CHADDICK DR. SE DECISION MADE: 25-MAR-05 WHEELING, IL 60090 510(k) STATEMENT DEVICE: VITA PM 7 (20 GRAM BOTTLES), VITA PM 7 (50 GRAM BOTTLES) VIDENT 510(k) NO: K050362(TRADITIONAL)
ATTN: BARBARA J LEWANDOWSKI PHONE NO : 714-961-6200 3150 EAST BIRCH ST. SE DECISION MADE: 15-MAR-05 BREA, CA 92821 510(k) STATEMENT DEVICE: APOLLO VILLA SISTEMI MEDICALI S.P.A. 510(k) NO: K050190(ABBREVIATED)
ATTN: VERONICA MEREDITH PHONE NO : 847-288-7000 11550 WEST KING ST. SE DECISION MADE: 25-MAR-05 FRANKLIN PARK, IL 60131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK VOLK OPTICAL, INC. 510(k) NO: K050623(SPECIAL)
ATTN: RICHARD E LIPPMAN PHONE NO : 240-683-3738 15825 SHADY GROVE RD. SE DECISION MADE: 28-MAR-05 SUITE 30 510(k) SUMMARY AVAILABLE FROM FDA ROCKVILLE, MD 20850 DEVICE: 12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200 WELCH ALLYN, INC. 510(k) NO: K050074(ABBREVIATED)
ATTN: CHRISTOPHER KLACZYKN PHONE NO : 315-685-3694 4341 STATE ST. RD. SE DECISION MADE: 22-MAR-05 SKANEATELES FALLS, NY 13153-0220 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WU'S 4-WHEELED NEO SCOOTER, WT-XL4 WU'S TECH CO., LTD. 510(k) NO: K050042(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 14-MAR-05 HSIN-CHU CITY, CHINA (TAIWAN) ROC 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEMPTOUCH DERMAL THERMOMETER XILAS MEDICAL, INC. 510(k) NO: K050137(TRADITIONAL)
ATTN: RUBEN G ZAMORANO PHONE NO : 210-692-1114 12665 SILICON DR. SE DECISION MADE: 18-MAR-05 SAN ANTONIO, TX 78249-3412 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: SYNTHETIC POWEDERED VINYL EXAMINATION GLOVES ZIBO BLUE INTCO PLASTIC & RUBBER P510(k) NO: K050455(TRADITIONAL)
ATTN: KAREN ABELL PHONE NO : 909-548-4828 12390 EAST END AVENUE SE DECISION MADE: 29-MAR-05 CHINO, CA 91710 510(k) STATEMENT DEVICE: PRE-POWDERED VINYL EXAM GLOVES ZIBO HENGCHANG PLASTIC & RUBBER PR510(k) NO: K042951(TRADITIONAL)
ATTN: MARY ANNE DOUCETTE PHONE NO : 760-318-4973 10 SETON COURT SE DECISION MADE: 10-MAR-05 RANCHO MIRAGE, CA 92270 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: VINYL EXAM GLOVE, POWDER-FREE, NON-STERILE ZIBO HENGCHANG PLASTIC & RUBBER PR510(k) NO: K042952(TRADITIONAL)
ATTN: MARY ANNE DOUCETTE PHONE NO : 760-318-4973 10 SETON COURT SE DECISION MADE: 10-MAR-05 RANCHO MIRAGE, CA 92270 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: MODIFICATION TO DYNESYS SPINAL SYSTEM ZIMMER SPINE, INC 510(k) NO: K043565(SPECIAL)
ATTN: TIM CRABTREE PHONE NO : 952-857-5631 7375 BUSH LAKE RD. SE DECISION MADE: 11-MAR-05 MINNEAPOLIS, MN 55439-2027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCR ZIMMER, INC. 510(k) NO: K043101(SPECIAL)
ATTN: BRANDON HIPSHER PHONE NO : 574-371-8083 P.O. BOX 708 SE DECISION MADE: 07-MAR-05 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 284 TOTAL WITH SUMMARIES 242 TOTAL WITH STATEMENTS 42
Updated April 5, 2005
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