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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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