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510(k)s Final Decisions Rendered for February 2001 |
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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-FEB-2001 THROUGH 28-FEB-2001
DEVICE: OCO DENTAL IMPLANT
"O" CO., INC. 510(k) NO: K010142(SPECIAL)
ATTN: DAVID D DALISE PHONE NO : 505-293-0025
600 PAISANO, N.E., SUITE A SE DECISION MADE: 01-FEB-01
ALBUQUERQUE, NM 87123 510(k) STATEMENT
DEVICE: UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450
A & A MEDICAL, INC. 510(k) NO: K010056(TRADITIONAL)
ATTN: JIHAD MANSOUR PHONE NO : 770-343-8400
9370 INDUSTRIAL TRACE SE DECISION MADE: 01-FEB-01
ALPHARETTA, GA 30004-3383 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALI 3D TOOL MODULE FOR MEDICAL IMAGES
A.L.I. TECHNOLOGIES, INC. 510(k) NO: K003762(TRADITIONAL)
ATTN: ROBERT MACNEIL PHONE NO : 604 279 5422
130- 10711 CAMBIE ROAD SE DECISION MADE: 28-FEB-01
RICHMOND, B.C., CANADA V6X 3G5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II
A.R.C. LASER AG 510(k) NO: K003512(TRADITIONAL)
ATTN: DANIEL HOEFER PHONE NO : 801-972-1311
2417 SOUTH 3850 WEST SE DECISION MADE: 08-FEB-01
SALT LAKE CITY, UT 84120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACE SDS 3.75MM SCREW DENTAL IMPLANT
ACE SURGICAL SUPPLY CO., INC. 510(k) NO: K002075(TRADITIONAL)
ATTN: J. EDWARD CARCHIDI PHONE NO : 508-588-3100
1034 PEARL STREET SE DECISION MADE: 02-FEB-01
P.O. BOX 1710 510(k) STATEMENT
BROCKTON, MA 02403
DEVICE: ACTHERM DIGITAL CLINICAL THERMOMETER, MODELS ACT2000, ACT2010, A
ACTHERM, INC. 510(k) NO: K010238(TRADITIONAL)
ATTN: RICHARD HSIEH PHONE NO : 886 355 37315
10TH F. #43 KUAN-MIN 6 ROAD SE DECISION MADE: 06-FEB-01
JUBEI, HSINCHU, CHINA (TAIWAN) 302510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: P3IMRT TM
ADAC LABORATORIES 510(k) NO: K002237(TRADITIONAL)
ATTN: JANICE E BROWN PHONE NO : 408-468-3766
540 ALDER DR. SE DECISION MADE: 02-FEB-01
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY
AESCULAP, INC. 510(k) NO: K003608(TRADITIONAL)
ATTN: LISA M MILLINGTON PHONE NO : 800-258-1946
944 MARCON BLVD SE DECISION MADE: 20-FEB-01
ALLENTOWN, PA 18109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSPEED EC MOTORSYSTEM GD650/GD653
AESCULAP, INC. 510(k) NO: K003612(TRADITIONAL)
ATTN: JOYCE THOMAS PHONE NO : 800-258-1946
3773 EXECUTIVE CENTER PARKWAY SE DECISION MADE: 20-FEB-01
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2010 PLUS HOLTER FOR WINDOWS
AGILENT TECHNOLOGIES 510(k) NO: K003940(SPECIAL)
ATTN: GRETEL LUMLEY PHONE NO : 800-235-5941
1201 "B" N. RICE AVE SE DECISION MADE: 08-FEB-01
OXNARD, CA 93030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODU
AGILENT TECHNOLOGIES DEUTSCHLAND G510(k) NO: K002758(TRADITIONAL)
ATTN: EGON PFEIL PHONE NO : 031-464-7223
HERRENBERGER STRASSE 130 SE DECISION MADE: 22-FEB-01
D 71034 BOEBLINGEN 510(k) SUMMARY AVAILABLE FROM FDA
BOEBLINGEN,, GERMANY D 71034
DEVICE: M2376A DEVICELINK SYSTEM
AGILENT TECHNOLOGIES, INC. 510(k) NO: K010048(SPECIAL)
ATTN: MIKE HUDON PHONE NO : 978-659-3173
3000 MINUTEMAN RD. SE DECISION MADE: 01-FEB-01
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M2376A DEVICELINK SYSTEM, MODEL M2376A
AGILENT TECHNOLOGIES, INC. 510(k) NO: K010342(SPECIAL)
ATTN: MIKE HUDON PHONE NO : 978-659-3173
3000 MINUTEMAN RD. SE DECISION MADE: 14-FEB-01
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILE NITRILE POWDER-FREE EXAMINATION GLOVES
ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K010211(SPECIAL)
ATTN: ERICA SETHI PHONE NO : 847-473-1500
1500 WAUKEGAN RD. SE DECISION MADE: 15-FEB-01
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPLETE BRAND MULTI-PURPOSE SOLUTION
ALLERGAN, INC. 510(k) NO: K003252(TRADITIONAL)
ATTN: PAUL J NOWACKI PHONE NO : 714-246-6761
2525 DUPONT DR. SE DECISION MADE: 21-FEB-01
IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOJAVE CATARACT EXTRACTION SYSTEM
ALLERGAN, INC. 510(k) NO: K003638(ABBREVIATED)
ATTN: MARK O'DONNELL PHONE NO : 714-246-2226
2525 DUPONT DR. SE DECISION MADE: 13-FEB-01
IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT L
AMERICAN BIOCURVE, INC. 510(k) NO: K001585(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490
623 GLACIER DR. SE DECISION MADE: 13-FEB-01
GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOLY DRAGON ACUPUNCTURE NEEDLES
ANC IMPORT & EXPORT CO. LTD. 510(k) NO: K002910(TRADITIONAL)
ATTN: WILLIAM ZHANG PHONE NO : 817-572-6790
4309 MURWICK DRIVE SE DECISION MADE: 07-FEB-01
ARLINGTON, TX 76016 510(k) STATEMENT
DEVICE: APPLIED BIOTECH, INC. SURESTEP ER DRUG SCREEN TEST
APPLIED BIOTECH, INC. 510(k) NO: K003160(TRADITIONAL)
ATTN: DAVE D SMITH PHONE NO : 858-713-9614
10237 FLANDERS CT. SE DECISION MADE: 08-FEB-01
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: SUCTION IRRIGATOR
APPLIED MEDICAL 510(k) NO: K003443(TRADITIONAL)
ATTN: ANIL BHALANI PHONE NO : 949-713-8327
22872 AVENIDA EMPRESA SE DECISION MADE: 01-FEB-01
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-SEPT TRANSSEPTAL SHEATH AND TRANSITION CATHETER, MODEL MV-03-0
APPRIVA MEDICAL, INC. 510(k) NO: K002054(TRADITIONAL)
ATTN: MICHAEL KOLBER PHONE NO : 650-691-4595
777 NORTH PASTORIA AVENUE SE DECISION MADE: 16-FEB-01
SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AURORA
AURORA IMAGING TECHNOLOGY, INC. 510(k) NO: K003651(TRADITIONAL)
ATTN: JAMES J ROGERS PHONE NO : 800-858-8667
46 JONSPIN RD. SE DECISION MADE: 21-FEB-01
WILMINGTON, MA 01887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRASOUND SCANNER TYPE 2101
B-K MEDICAL A/S 510(k) NO: K003041(TRADITIONAL)
ATTN: VILLY BRAENDER PHONE NO : 011 454 5970100
SANDTOFTEN 9 SE DECISION MADE: 07-FEB-01
GENTOFTE, DENMARK DK-2820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN
BANTA HEALTHCARE 510(k) NO: K003749(TRADITIONAL)
ATTN: YOLNDA SMITH PHONE NO : 410-451-0639
PO BOX 4341 SE DECISION MADE: 23-FEB-01
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: SYNTRA DIALYZER, MODEL SYNTRA 120, 160
BAXTER HEALTHCARE CORP. 510(k) NO: K002210(TRADITIONAL)
ATTN: ROBERT L WILKINSON PHONE NO : 847-473-6335
1620 WAUKEGAN RD., MPR-A2E SE DECISION MADE: 14-FEB-01
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA 120 HEMATOLOGY
BAYER CORP. 510(k) NO: K003796(TRADITIONAL)
ATTN: FREDRICK CLERIE PHONE NO : 914-524-2954
511 BENEDICT AVE. SE DECISION MADE: 05-FEB-01
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CA
BAYLIS MEDICAL CO., INC. 510(k) NO: K990284(TRADITIONAL)
ATTN: KRIS SHAH PHONE NO : 905 602 4875
5160 EXPLORER DRIVE, UNIT 5 SE DECISION MADE: 01-FEB-01
MISSISSAUGA, CANADA L4W-4T7 510(k) STATEMENT
DEVICE: BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE
BD BECTON DICKINSON VACUTAINER SYS510(k) NO: K003461(TRADITIONAL)
ATTN: M. WENDY BOSSHARDT PHONE NO : 201-847-6280
1 BECTON DR. SE DECISION MADE: 01-FEB-01
FRANKLIN LAKES, NJ 07417-1880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190
BECKMAN COULTER, INC. 510(k) NO: K010064(SPECIAL)
ATTN: STAN SUGRUE PHONE NO : 305-380-4552
11800 SW 147TH AVE. SE DECISION MADE: 07-FEB-01
MIAMI, FL 33196-2500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 5C-ES CELL CONTROL, MODELS 7547191, 7547192
BECKMAN COULTER, INC. 510(k) NO: K010066(SPECIAL)
ATTN: STAN SUGRUE PHONE NO : 305-380-4552
11800 SW 147TH AVE. SE DECISION MADE: 07-FEB-01
MIAMI, FL 33196-2500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726
BENTEC MEDICAL, INC. 510(k) NO: K002650(TRADITIONAL)
ATTN: DAVID TUCKER PHONE NO : 530-406-3333
1380 EAST BEAMER ST. SE DECISION MADE: 16-FEB-01
WOODLAND, CA 95776 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOLOK SCREW, BIOSTEON SCREW
BIOCOMPOSITES LTD. 510(k) NO: K003641(TRADITIONAL)
ATTN: J.STEPHEN BRATT PHONE NO : 441 782 206500
ETRUSCAN ST., ETRURIA SE DECISION MADE: 08-FEB-01
STOKE ON TRENT, UNITED KINGDOM ST1510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOLUCENT MAMMOGRAPHY CUSHION
BIOLUCENT, INC. 510(k) NO: K003795(TRADITIONAL)
ATTN: STEVE GEX PHONE NO : 949-349-1380
27121 ALISO CREEK ROAD SE DECISION MADE: 14-FEB-01
SUITE 125 510(k) SUMMARY AVAILABLE FROM FDA
ALISO VIEJO, CA 92656
DEVICE: EZ-HCG URINE(PREGNANCY TEST)
BIOMERICA, INC. 510(k) NO: K003856(TRADITIONAL)
ATTN: JAY SINGH PHONE NO : 949-645-2111
1533 MONROVIA AVE. SE DECISION MADE: 21-FEB-01
NEWPORT BEACH, CA 92663 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3I CALCIUM SODIUM PHOSPHATE BONE CEMENT
BIOMET, INC. 510(k) NO: K003493(TRADITIONAL)
ATTN: SARA A BAILEY PHONE NO : 219-372-1568
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 09-FEB-01
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: OFFSET TIBIAL TRAY
BIOMET, INC. 510(k) NO: K010212(SPECIAL)
ATTN: CAROL LAUSTER PHONE NO : 219-267-6639
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 14-FEB-01
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040
BIONX IMPLANTS, INC. 510(k) NO: K003659(TRADITIONAL)
ATTN: TUIJA ANNALA PHONE NO : 358 331 65600
HERMIANKATU 6-8 L SE DECISION MADE: 20-FEB-01
TAMPERE, FINLAND FIN-33720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMOFX MESH
BIONX IMPLANTS, LTD. 510(k) NO: K003757(TRADITIONAL)
ATTN: TUIJA ANNALA PHONE NO : 358 331 65600
HERMIANKATU 6-8 L SE DECISION MADE: 07-FEB-01
TAMPERE, FINLAND FIN-33720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINIQUANT D-DIMER, MODEL 1447
BIOPOOL INTL., INC. 510(k) NO: K002642(TRADITIONAL)
ATTN: MICHAEL D BICK PHONE NO : 805-654-0643
6025 NICOLLE ST., SUITE D SE DECISION MADE: 05-FEB-01
VENTURA, CA 93003 510(k) STATEMENT
DEVICE: MODIFICATION TO ARTOSCAN M
BIOSOUND ESAOTE, INC. 510(k) NO: K010057(SPECIAL)
ATTN: COLLEEN HITTLE PHONE NO : 317-849-1793
8000 CASTLEWAY DR. SE DECISION MADE: 02-FEB-01
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONSTELLATION CATHETER, MODEL 8031
BOSTON SCIENTIFIC CORP. 510(k) NO: K003782(SPECIAL)
ATTN: ANDREA BOUMIS PHONE NO : 408-895-3625
2710 ORCHARD PARKWAY SE DECISION MADE: 14-FEB-01
SAN JOSE, CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Z-TOUCH
BRAINLAB, AG 510(k) NO: K003268(TRADITIONAL)
ATTN: PHONE NO :
100 MARINE PARKWAY SE DECISION MADE: 22-FEB-01
SUITE 305 510(k) SUMMARY AVAILABLE FROM FDA
REDWOOD CITY, CA 94065
DEVICE: BMR DENTAL IMPLANT SYSTEM, MODEL 3.3XX, EITHER HA OR TPS COATED,
BUCK MEDICAL RESEARCH 510(k) NO: K010343(TRADITIONAL)
ATTN: REBECCA ELLIS PHONE NO : 214-522-5780
2811 LEMMON AVE., SUITE 201 SE DECISION MADE: 14-FEB-01
DALLAS, TX 75204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARD UTRAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER
C.R. BARD, INC. 510(k) NO: K010169(SPECIAL)
ATTN: CAROL VIERLING PHONE NO : 770-385-2347
13183 HARLAND DRIVE SE DECISION MADE: 13-FEB-01
COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANTAGE SINGLE-USE ELECTROSURGICAL ATTACHMENT-J-HOOK TIP, L-HO
C.R. BARD, INC. 510(k) NO: K010444(TRADITIONAL)
ATTN: KERRY CHUNKO PHONE NO : 785-843-7782
700 EAST 22ND ST SE DECISION MADE: 28-FEB-01
LAWRENCE, KS 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CARDIOMEDICS ECP SYSTEM
CARDIOMEDICS, INC. 510(k) NO: K010261(SPECIAL)
ATTN: JOHN HUTCHINS PHONE NO : 949-863-2500
18872 BARDEEN AVE. SE DECISION MADE: 28-FEB-01
IRVINE, CA 92612 510(k) STATEMENT
DEVICE: VISULAS YAG II
CARL ZEISS, INC. 510(k) NO: K003885(TRADITIONAL)
ATTN: SCOTT A MARGOLIN PHONE NO : 914-681-7880
ONE ZEISS DR. SE DECISION MADE: 22-FEB-01
THORNWOOD, NY 10594 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUAL LUMEN MIDLINE CATHETER
CATHETER INNOVATIONS, INC. 510(k) NO: K010349(SPECIAL)
ATTN: ROGER L RICHINS PHONE NO : 801-954-8444
3598 WEST 1820 SOUTH SE DECISION MADE: 28-FEB-01
SALT LAKE CITY, UT 84104-4859 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENSES
CIBA-GEIGY CORP. 510(k) NO: K003586(TRADITIONAL)
ATTN: STEVEN DOWDLEY PHONE NO : 678-415-3897
11460 JOHNS CREEK PKWY. SE DECISION MADE: 08-FEB-01
DULUTH, GA 30136-1518 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE
COALESCENT SURGICAL 510(k) NO: K003958(TRADITIONAL)
ATTN: MICHAEL A DANIEL PHONE NO : 415-407-0223
559 EAST WEDDELL DR. SE DECISION MADE: 06-FEB-01
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS
CODMAN & SHURTLEFF, INC. 510(k) NO: K003549(TRADITIONAL)
ATTN: JAMES M FLAHERTY PHONE NO : 508-880-8404
325 PARAMOUNT DR. SE DECISION MADE: 15-FEB-01
RAYNHAM, MA 02767-0350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAPER-FIT TOTAL HIP SYSTEM
CORIN U.S.A. 510(k) NO: K003666(TRADITIONAL)
ATTN: JOEL K BATTS PHONE NO : 813-977-4469
10500 UNIVERSITY CENTER DR., SE DECISION MADE: 08-FEB-01
SUITE 190 510(k) SUMMARY AVAILABLE FROM FDA
TAMPA, FL 33612
DEVICE: TRI-FIT FEMORAL STEM
CORIN U.S.A. 510(k) NO: K010243(SPECIAL)
ATTN: JOEL K BATTS PHONE NO : 813-977-4469
10500 UNIVERSITY CENTER DR., SE DECISION MADE: 15-FEB-01
SUITE 190 510(k) SUMMARY AVAILABLE FROM FDA
TAMPA, FL 33612
DEVICE: SERENOCEM, MODEL BC 010
CORINTHIAN MEDICAL LTD. 510(k) NO: K003567(TRADITIONAL)
ATTN: DAGMAR MASER PHONE NO : 312 042 89591
AMSTEL 320-1 SE DECISION MADE: 12-FEB-01
AMERSTDAM, NETHERLANDS 1017 AP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORTEX METAMAX
CORTEX BIOPHYSIK GMBH 510(k) NO: K001631(TRADITIONAL)
ATTN: ART WARD PHONE NO : 813-645-2855
962 ALLEGRO LANE SE DECISION MADE: 22-FEB-01
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTROL MODULE ALGORITHM ENHANCEMENT FOR THE MODEL S500-ST AND M
CURON MEDICAL, INC. 510(k) NO: K010210(SPECIAL)
ATTN: THOMAS C WEHMAN PHONE NO : 408-733-9910
735 PALOMAR ST. SE DECISION MADE: 21-FEB-01
SUNNYVALE, CA 94086 510(k) STATEMENT
DEVICE: RCRP FLEX REAGENT CARTRIDGE
DADE BEHRING, INC. 510(k) NO: K003419(TRADITIONAL)
ATTN: LORRAINE H PIETRAK PHONE NO : 302-631-6279
GLASGOW BUSINESS COMMUNITY; SE DECISION MADE: 14-FEB-01
BLDG. 500 MAIL BOX 514 510(k) SUMMARY AVAILABLE FROM FDA
P.O. BOX 6101, NEWARK, DE 19714-6101
DEVICE: THROMBOREL S
DADE BEHRING, INC. 510(k) NO: K003870(TRADITIONAL)
ATTN: REBECCA S AYASH PHONE NO : 302-631-6276
P.O. BOX 6101 SE DECISION MADE: 20-FEB-01
NEWARK,, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION PSA FLEX REAGENT CARTRIDGE
DADE BEHRING, INC. 510(k) NO: K003963(TRADITIONAL)
ATTN: GEORGE M PLUMMER PHONE NO : 302-631-9798
GLASGOW BUSINESS COMMUNITY; SE DECISION MADE: 28-FEB-01
BLDG. 500 P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137
DADE BEHRING, INC. 510(k) NO: K010208(TRADITIONAL)
ATTN: RICHARD M VAUGHT PHONE NO : 302-631-6567
GLASCO B500 M.S. 514 SE DECISION MADE: 20-FEB-01
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: AML HIP PROSTHESIS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K003800(TRADITIONAL)
ATTN: MARCIA J ARENTZ PHONE NO : 219-371-4944
700 ORTHOPAEDIC DR. SE DECISION MADE: 09-FEB-01
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: ELECTRICATOR MODEL 26000
DERMATOLOGIC LAB & SUPPLY, INC. 510(k) NO: K010025(TRADITIONAL)
ATTN: DEBORAH GRAFELMAN PHONE NO : 712-323-3269
608 13TH AVE. SE DECISION MADE: 22-FEB-01
COUNCIL BLUFFS, IA 51501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE M
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K003597(TRADITIONAL)
ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 05-FEB-01
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMU
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K004002(TRADITIONAL)
ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 14-FEB-01
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASSERACHROM HPIA TEST KIT
DIAGNOSTICA STAGO, INC. 510(k) NO: K003767(TRADITIONAL)
ATTN: ANDREW LOC B LE PHONE NO : 973-631-1200
FIVE CENTURY DR. SE DECISION MADE: 12-FEB-01
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASE-A-CULT
DIAGNOSTICA, INC. 510(k) NO: K002756(TRADITIONAL)
ATTN: YOLANDA SMITH PHONE NO : 410-451-0639
P.O. BOX 4341 SE DECISION MADE: 23-FEB-01
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID
DISETRONIC MEDICAL SYSTEMS AG 510(k) NO: K003977(TRADITIONAL)
ATTN: DAVID E CHADWICK PHONE NO : 763-795-5277
5151 PROGRAM AVENUE SE DECISION MADE: 15-FEB-01
ST. PAUL, MN 55112-1014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICTEC ENDOSCOPES AND ACCESSORIES
DUFNER INSTRUMENTE GMBH 510(k) NO: K002877(ABBREVIATED)
ATTN: DAGMAR MASER PHONE NO : 312 042 89591
AMSTEL 320-I SE DECISION MADE: 05-FEB-01
AMSTERDAM, NETHERLANDS 1017AP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUO-DENT DENTAL IMPLANT
DUO-DENT DENTAL IMPLANT SYSTEMS LL510(k) NO: K010386(SPECIAL)
ATTN: MICHAEL H VOVOLKA PHONE NO : 847-856-0355
P.O. BOX 848 SE DECISION MADE: 27-FEB-01
GRAYSLAKE, IL 60030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI VUECATH SPINAL ENDOSCOPIC SYSTEM
EBI, L.P. 510(k) NO: K010179(SPECIAL)
ATTN: JON CAPAROTTA PHONE NO : 973-299-9022
100 INTERPACE PKWY. SE DECISION MADE: 09-FEB-01
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS
EDAP TECHNOMED, INC. 510(k) NO: K003529(ABBREVIATED)
ATTN: SCOTT J MINDREBO PHONE NO : 770-446-9950
100 PINNACLE WAY, SUITE 100 SE DECISION MADE: 12-FEB-01
NORCROSS, GA 30071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS
ENVIRONMENTAL TEST SYSTEMS, INC. 510(k) NO: K003615(SPECIAL)
ATTN: BRUCE G PIEKARSKI PHONE NO : 219-262-2060
P.O. BOX 4659 SE DECISION MADE: 01-FEB-01
ELKHART, IN 46514 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREEDLAND TENSION SYSTEM
ETZEM TECHNOLOGIES, INC. 510(k) NO: K003648(TRADITIONAL)
ATTN: AHAVA SHEIN PHONE NO : 972 976 70002
20 HATA'AS ST. SE DECISION MADE: 23-FEB-01
BEIT HAPA'AMON BOX 124 510(k) STATEMENT
KFAR SABA, ISRAEL 44425
DEVICE: CEMEX SYSTEM GUN APPLICATION VERSION
EXACTECH, INC. 510(k) NO: K000943(TRADITIONAL)
ATTN: GARY J MILLER PHONE NO : 352-377-1140
2320 N.W. 66TH COURT SE DECISION MADE: 08-FEB-01
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS
EXACTECH, INC. 510(k) NO: K010081(SPECIAL)
ATTN: LISA SIMPSON PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 05-FEB-01
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO EXACTECH ACUMATCH INTEGRATED HIP SYSTEM, M-SERIE
EXACTECH, INC. 510(k) NO: K010120(SPECIAL)
ATTN: GARY J MILLER PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 09-FEB-01
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EEG WITH VIDEO, MODEL EX-NW
EXCEL TECH. LTD. 510(k) NO: K010091(SPECIAL)
ATTN: SONJA MARKEZ PHONE NO : 905 829 5300
2568 BRISTOL CIRCLE SE DECISION MADE: 01-FEB-01
OAKVILLE, ONTARIO, CANADA L6H 5S1510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 64 CHANNEL EEG / MODEL NUMBER EX-NW-64
EXCEL TECH. LTD. 510(k) NO: K010150(SPECIAL)
ATTN: SONJA MARKEZ PHONE NO :
2568 BRISTOL CIRCLE SE DECISION MADE: 09-FEB-01
OAKVILLE, ONTARIO, CANADA L6H 5S1510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET
EXELINT INTERNATIONAL COMPANY 510(k) NO: K003627(TRADITIONAL)
ATTN: ARMAND HAMID PHONE NO : 310-649-0707
5840 W. CENTINELA AVENUE SE DECISION MADE: 08-FEB-01
LOS ANGELES, CA 90231-3194 510(k) STATEMENT
DEVICE: EYETECT TREMOR MONITOR UNIT (TMU)
EYETECT, L.L.C. 510(k) NO: K003644(TRADITIONAL)
ATTN: REBECCA M CUETO PHONE NO : 618-235-8609
10 MADONNA COURT SE DECISION MADE: 01-FEB-01
BELLEVILLE,, IL 62223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FADASSI MEDICAL FM-1 NO BLENDER
FADASIS MEDICAL, INC. 510(k) NO: K003665(TRADITIONAL)
ATTN: RAYMOND RIDDLE PHONE NO : 608-831-0025
7601-B MURPHY DRIVE SE DECISION MADE: 23-FEB-01
MIDDLETOWN, WI 53562 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: (DISPOSABLE) VAGINAL SPECULUM
FEMINICA INC. 510(k) NO: K003540(TRADITIONAL)
ATTN: DENIS H DUBOIS PHONE NO : 514 875 4422
3216 MONSABRE SE DECISION MADE: 09-FEB-01
MONTREAL, QUEBEC, CANADA H1N 2L5 510(k) STATEMENT
DEVICE: MICROTARGETING DRIVE SYSTEM
FHC, INC. 510(k) NO: K003776(TRADITIONAL)
ATTN: FREDERICK HAER PHONE NO : 207-666-8190
9 MAIN STREET SE DECISION MADE: 23-FEB-01
BOWDOINHAM, ME 04008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL
GE MEDICAL SYSTEMS 510(k) NO: K003946(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 414-544-3894
P.O. BOX 414, W-709 SE DECISION MADE: 27-FEB-01
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANTAGE WINDOWS CT/PET FUSION
GE MEDICAL SYSTEMS, INC. 510(k) NO: K010336(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
P.O. BOX 414 SE DECISION MADE: 16-FEB-01
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09
GEBAUER CO. 510(k) NO: K002596(TRADITIONAL)
ATTN: DENISE E SPELLMAN PHONE NO : 216-271-0910
9410 ST. CATHERINE AVE. SE DECISION MADE: 15-FEB-01
CLEVELAND, OH 44104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: URETEROSCOPES
GLOBAL ENDOSCOPY, INC. 510(k) NO: K003806(TRADITIONAL)
ATTN: NICK MIRCEA PHONE NO : 847-301-2733
914 W. ESTES CT. SE DECISION MADE: 22-FEB-01
SCHAUMBURG, IL 60193-4426 510(k) STATEMENT
DEVICE: CYSTOSCOPES
GLOBAL ENDOSCOPY, INC. 510(k) NO: K003807(TRADITIONAL)
ATTN: NICK MIRCEA PHONE NO : 847-301-2733
914 W. ESTES CT. SE DECISION MADE: 22-FEB-01
SCHAUMBURG, IL 60193-4426 510(k) STATEMENT
DEVICE: ANCURE LLIAC BALLOON CATHETER
GUIDANT CARDIAC AND VASCULAR SURGE510(k) NO: K003495(TRADITIONAL)
ATTN: JACQUELINE J JACKSON PHONE NO : 650-470-6200
1525 O'BRIEN DR. SE DECISION MADE: 07-FEB-01
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NITRILE EXAMINATION GLOVES (POWERED)
GUTHRIE MEDICARE PRODUCTS (NS) SDN510(k) NO: K003922(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 15-FEB-01
GREAT NECK, NY 11021 510(k) STATEMENT
DEVICE: POWDERFREE NITRILE PATIENT EXMINATION GLOVE
GUTHRIE MEDICARE PRODUCTS (NS) SDN510(k) NO: K003985(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 09-FEB-01
GREAT NECK, NY 11021 510(k) STATEMENT
DEVICE: MAC ACUPUNCTURE NEEDLE
HAENGLIM SEOWON CORP. 510(k) NO: K002827(TRADITIONAL)
ATTN: YUN CHOL CHO PHONE NO : 718-886-4469
34-69 LEAVITT ST. SE DECISION MADE: 28-FEB-01
FLUSHING, NY 11354 510(k) STATEMENT
DEVICE: TRITON HIP SYSTEM
HAYES MEDICAL, INC. 510(k) NO: K003649(TRADITIONAL)
ATTN: WILLIAM J GRIFFIN PHONE NO : 916-355-7156
1115 WINDFIELD WAY, SUITE 100 SE DECISION MADE: 23-FEB-01
EL DORADO HILLS, CA 95762-9623 510(k) STATEMENT
DEVICE: MEDRELIEF
HEALTHONICS, INC. 510(k) NO: K003507(TRADITIONAL)
ATTN: T. WHIT ATHEY PHONE NO : 301-770-9590
12300 TWINBROOK PARKWAY SE DECISION MADE: 21-FEB-01
SUITE 625 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20852
DEVICE: ACCUFUSER; ACCUFUSER PLUS
HELPTECHNOLOGIES 510(k) NO: K003915(TRADITIONAL)
ATTN: ROBERT J BARD PHONE NO : 949-240-1290
24312 ARMADA DR. SE DECISION MADE: 15-FEB-01
DANA POINT, CA 92629 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEXTIME MAGNUM 360
HERAEUS KULZER, INC. 510(k) NO: K003930(TRADITIONAL)
ATTN: CHERYL ZIMMERMAN PHONE NO : 219-299-6662
4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 01-FEB-01
SOUTH BEND, IN 46614-2517 510(k) STATEMENT
DEVICE: MODULAR
HEYER AMERICA, INC. 510(k) NO: K001988(TRADITIONAL)
ATTN: ART WARD PHONE NO : 813-645-2855
962 ALLEGRO LANE SE DECISION MADE: 05-FEB-01
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VORTEX ACCESS SYSTEM
HORIZON MEDICAL PRODUCTS, INC. 510(k) NO: K010189(SPECIAL)
ATTN: PENNY M NORTHCUTT PHONE NO : 706-846-3126
1 HORIZON WAY SE DECISION MADE: 12-FEB-01
MANCHESTER, GA 31816 510(k) STATEMENT
DEVICE: TEKNIQUE
HOVEROUND CORP. 510(k) NO: K010075(SPECIAL)
ATTN: TONY DIGIOVANNI PHONE NO : 941-739-6200
2151 WHITFIELD INDUSTRIAL WAY SE DECISION MADE: 14-FEB-01
SARASOTA, FL 34243 510(k) STATEMENT
DEVICE: ENHANCED POLYETHYLENE KNEE PROSTHESES
HOWMEDICA OSTEONICS CORP. 510(k) NO: K001147(TRADITIONAL)
ATTN: MARY-CATHERINE DILLON PHONE NO : 201-760-8117
59 ROUTE 17 SE DECISION MADE: 15-FEB-01
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES
I.C. MEDICAL, INC. 510(k) NO: K003840(TRADITIONAL)
ATTN: CRAIG HARSHMAN PHONE NO : 623-780-0700
2002 WEST QUAIL AVE SE DECISION MADE: 01-FEB-01
PHOENIX, AZ 85027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECIALTY 55 & MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC CONT
IGEL VISIONCARE PTE LTD. 510(k) NO: K003833(TRADITIONAL)
ATTN: JOHN M SZABOCSIK PHONE NO : 312-553-0828
203 NORTH WABASH AVENUE SE DECISION MADE: 13-FEB-01
SUITE 1200 510(k) SUMMARY AVAILABLE FROM FDA
CHICAGO, IL 60601
DEVICE: INTRAVASCULAR ADMINISTRATION SET
INFUSION DEVICES, INC. 510(k) NO: K003854(TRADITIONAL)
ATTN: PAUL E DRYDEN PHONE NO : 317-335-3780
6329 W. WATERVIEW CT. SE DECISION MADE: 05-FEB-01
MCCORDSVILLE, IN 46055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO-EYE II ORBITAL IMPLANT
INTEGRATED ORBITAL IMPLANTS, INC. 510(k) NO: K003338(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
4329 GRAYDON ROAD SE DECISION MADE: 07-FEB-01
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHALLENGER DIRECT COMPOSITE
INTERNATIONAL DENTAL RESEARCH 510(k) NO: K010219(SPECIAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVE. SE DECISION MADE: 21-FEB-01
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOTAL BILIRUBIN REAGENT
INTERSECT SYSTEMS, INC. 510(k) NO: K003892(TRADITIONAL)
ATTN: JOAN CATHEY PHONE NO : 360-577-1062
P.O. BOX 2219 SE DECISION MADE: 20-FEB-01
LONGVIEW, WA 98632 510(k) STATEMENT
DEVICE: MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LY
INVACARE CORP. 510(k) NO: K010135(TRADITIONAL)
ATTN: RAE A FARROW PHONE NO : 440-329-6356
ONE INVACARE WAY SE DECISION MADE: 16-FEB-01
ELYRIA, OH 44036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUTUREGROOVE WEIGHT SIZING SET
IOP, INC. 510(k) NO: K003646(TRADITIONAL)
ATTN: JASON MALECKA PHONE NO : 714-549-1185
3151 AIRWAY AVE., BLDG. I-1 SE DECISION MADE: 22-FEB-01
COSTA MESA, CA 92626 510(k) STATEMENT
DEVICE: MXR-2000 MOBILE X-RAY UNIT
IROM IMAGING, INC. 510(k) NO: K010304(TRADITIONAL)
ATTN: ROMAN KRYSTYNIAK PHONE NO : 303-762-1950
3720 SOUTH LIPAN ST. SE DECISION MADE: 12-FEB-01
ENGLEWOOD, CO 80110 510(k) STATEMENT
DEVICE: NUCAMMA BI90
IS2 RESEARCH INC. 510(k) NO: K003882(TRADITIONAL)
ATTN: VICTOR WOODBURN PHONE NO : 613 228 8755
20 GURDWARA RD., BAYS 3-6 SE DECISION MADE: 21-FEB-01
NEPEAN, ONTARIO, CANADA K2E 8B3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE
ITAMAR MEDICAL (C.M.) 1997 LTD. 510(k) NO: K001852(TRADITIONAL)
ATTN: AHAVA STEIN PHONE NO : 972 979 20673
P.O.B. 454 SE DECISION MADE: 21-FEB-01
GINOT SHOMRON 44853, ISRAEL 44853 510(k) STATEMENT
DEVICE: EXCITE DSC
IVOCLAR NORTH AMERICA, INC. 510(k) NO: K003293(TRADITIONAL)
ATTN: ANDY GULATI PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 06-FEB-01
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: TETRIC CERAM HB
IVOCLAR NORTH AMERICA, INC. 510(k) NO: K010250(TRADITIONAL)
ATTN: ANDY GULATI PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 28-FEB-01
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: TOTAL BILIRUBIN
JAS DIAGNOSTIC, INC. 510(k) NO: K003829(TRADITIONAL)
ATTN: DAVID JOHNSTON PHONE NO : 305-418-2320
7220 NW 58TH ST. SE DECISION MADE: 12-FEB-01
MIAMI, FL 33166 510(k) STATEMENT
DEVICE: PHOSPHORUS REAGENT
JAS DIAGNOSTIC, INC. 510(k) NO: K003912(TRADITIONAL)
ATTN: DAVID JOHNSTON PHONE NO : 305-418-2320
7220 NW 58TH ST. SE DECISION MADE: 21-FEB-01
MIAMI, FL 33166 510(k) STATEMENT
DEVICE: COSMIC
JENERIC/PENTRON, INC. 510(k) NO: K010044(TRADITIONAL)
ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397
53 NO.PLAINES INDUSTRIAL ROAD SE DECISION MADE: 09-FEB-01
WALLINGFORD, CT 06492-0724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JK GLOVES PRE-POWDERED LATEX EXAMINATION GLOVE
JK GLOVES SDN. BHD. 510(k) NO: K010231(TRADITIONAL)
ATTN: TAI SAI LEONG PHONE NO : 607 598 2568
LOT 26738 & 26740-K8 & P2 SE DECISION MADE: 09-FEB-01
JALAN TEE TECK SA 510(k) STATEMENT
SENAI, JOHOR, MALAYSIA 81400
DEVICE: X-RAY SYSTEM XR-MX
KARL STORZ ENDOSCOPY 510(k) NO: K004037(TRADITIONAL)
ATTN: JENNIFER S PORTUGAL PHONE NO : 800-421-0837
600 CORPORATE POINTE SE DECISION MADE: 02-FEB-01
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODULITH LITHOTRIPSY, MODEL SLX FOR THE FRAGMENTATION OF URINARY
KARL STORZ LITHOTRIPSY-AMERICA, IN510(k) NO: K010340(TRADITIONAL)
ATTN: MARIKA ANDERSON PHONE NO : 310-338-8100
600 CORPORATE POINTE SE DECISION MADE: 13-FEB-01
CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOPILOT
KINAMED, INC. 510(k) NO: K003347(TRADITIONAL)
ATTN: JOEL SLOMOFF PHONE NO : 301-983-1707
9229 CRANFORD DRIVE SE DECISION MADE: 23-FEB-01
POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATAB
KYPHON INC. 510(k) NO: K010246(TRADITIONAL)
ATTN: KAREN TALMADGE PHONE NO : 408-548-6500
1350 BORDEAUX DRIVE SE DECISION MADE: 14-FEB-01
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAI-CHI ACUPUNCTURE NEEDLES
LHASA MEDICAL, INC. 510(k) NO: K003760(TRADITIONAL)
ATTN: KYUNG P RIIHIMAKI PHONE NO : 781-340-1070
234 LIBBEY PARKWAY SE DECISION MADE: 06-FEB-01
WEYMOUTH, MA 02189 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRAVASCULAR IV SET, IV SET WITH BURETTE, EXTENSION SET
LIFEMED OF CALIFORNIA 510(k) NO: K001329(TRADITIONAL)
ATTN: PATRICIA BRINKER PHONE NO : 310-638-6167
1216 S. ALLEC ST. SE DECISION MADE: 14-FEB-01
ANAHEIM, CA 92805 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERSONAL GLUCOSE CONTROL CHARTING SYSTEM
LXN CORP. 510(k) NO: K002688(TRADITIONAL)
ATTN: SANDRA F SELVAGGI PHONE NO : 858-320-4434
6325 LUSK BLVD. SE DECISION MADE: 01-FEB-01
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: MAEDA NEW NEEDLE DISPOSABLE
MAEDA TOYOKICHI SHOTEN 510(k) NO: K000581(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 410-451-0639
P.O. BOX 4341 SE DECISION MADE: 23-FEB-01
CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ODYSSEY LX, MODEL 211320
MARCONI MEDICAL SYSTEMS 510(k) NO: K003437(TRADITIONAL)
ATTN: RONALD J MARTONE PHONE NO : 440-483-7651
595 MINER RD. SE DECISION MADE: 02-FEB-01
HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100
MARCONI MEDICAL SYSTEMS 510(k) NO: K003853(TRADITIONAL)
ATTN: DUANE PRASCHAN PHONE NO : 440-483-5743
595 MINER RD. SE DECISION MADE: 13-FEB-01
HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DURABOND NON-PRECIOUS CERAMIC ALLOY
MATECH, INC. 510(k) NO: K010069(TRADITIONAL)
ATTN: PAUL L SAXTON PHONE NO : 818-367-2472
13000 SAN FERNANDO RD. SE DECISION MADE: 15-FEB-01
SYLMAR, CA 91342 510(k) STATEMENT
DEVICE: SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE)
MAXXIM MEDICAL 510(k) NO: K010297(SPECIAL)
ATTN: WUNAN HUANG PHONE NO : 864-369-7391
308 CHURCH ST. SE DECISION MADE: 16-FEB-01
HONEA PATH, SC 29654 510(k) STATEMENT
DEVICE: MEDLOGICS ML 4000, MODEL 4000
MED-LOGICS, INC. 510(k) NO: K002515(TRADITIONAL)
ATTN: GARY MOCNIK PHONE NO : 949-363-2953
30001 GOLDEN LANTERN #334 SE DECISION MADE: 22-FEB-01
LAGUNA NIGUEL, CA 92677 510(k) STATEMENT
DEVICE: MEDGE PLATFORMS SONOCUBIC 3D ULTRASOUND SOFTWARE
MEDGE PLATFORMS, INC 510(k) NO: K003672(TRADITIONAL)
ATTN: GUSTAVO EDUARDO ABELLA PHONE NO : 212-808-4848
90 PARK AVENUE SE DECISION MADE: 22-FEB-01
17TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10016-1301
DEVICE: DIAMOND ALOE VERA, STERILE
MEDI-TECH INTL. CORP. 510(k) NO: K002666(TRADITIONAL)
ATTN: HERBERT A PERRY PHONE NO : 718-875-4535
26 COURT ST. SE DECISION MADE: 27-FEB-01
BROOKLYN, NY 11242 510(k) STATEMENT
DEVICE: EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZER
MEDICA CORP. 510(k) NO: K002407(TRADITIONAL)
ATTN: PHOTIOS MAKRIS PHONE NO : 781-275-4892
14 DEANGELO DR. SE DECISION MADE: 02-FEB-01
BEDFORD, MA 01730 510(k) STATEMENT
DEVICE: CARDIOIMMUNE TL CARDIAC MARKER CONTROL LEVELS 1, 2, 3, AND MULTI
MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K010111(TRADITIONAL)
ATTN: DARWIN RICHARDSON PHONE NO : 800-582-3095
5300 ADOLFO RD. SE DECISION MADE: 28-FEB-01
CAMARILLO, CA 93012 510(k) STATEMENT
DEVICE: MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S
MEDICAL COMPONENTS, INC. 510(k) NO: K010021(TRADITIONAL)
ATTN: FLORENCE A CAIKOSKI PHONE NO : 215-256-4201
1499 DELP DR. SE DECISION MADE: 23-FEB-01
HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARIETEX COMPOSITE (PCO) MESH
MEDICAL DEVICE CONSULTANTS, INC. 510(k) NO: K002699(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 15-FEB-01
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602
MEDICAL DEVICES, INC. 510(k) NO: K002280(TRADITIONAL)
ATTN: WARREN R WALTERS PHONE NO : 515-244-1212
2500 BELL AVENUE SE DECISION MADE: 05-FEB-01
DES MOINES, IA 50321 510(k) STATEMENT
DEVICE: NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGE
MEDICAL ILLUMINATION INTERNATIONAL510(k) NO: K003489(TRADITIONAL)
ATTN: DAVID GLOVER PHONE NO : 818-899-2888
547 LIBRARY ST. SE DECISION MADE: 02-FEB-01
SAN FERNANDO, CA 91340 510(k) STATEMENT
DEVICE: KIMAX, MODEL 1024
MEDICAL METRICS, INC. 510(k) NO: K010187(ABBREVIATED)
ATTN: ANN TUNSTALL PHONE NO : 301-652-6110
4600 NORTH PARK AVE. SE DECISION MADE: 14-FEB-01
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
CHEVY CHASE, MD 20815-4518
DEVICE: MULTI-FUNCTION DEFIBRILLATION ELECTRODE
MEDICOTEST A/S 510(k) NO: K002079(TRADITIONAL)
ATTN: EMALEE G MURPHY PHONE NO : 202-496-7255
1900 K STREET N.W. SE DECISION MADE: 22-FEB-01
WASHINGTON, DC 20006-1108 510(k) STATEMENT
DEVICE: MEDIVISION IGS SYSTEM
MEDISONIC U.S.A., INC. 510(k) NO: K003699(TRADITIONAL)
ATTN: SANDRA WILLIAMSON PHONE NO : 610-647-9700
1301 GOSHEN PARKWAY SE DECISION MADE: 27-FEB-01
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDITHERM MED2000
MEDITHERM INC. 510(k) NO: K003332(TRADITIONAL)
ATTN: PETER LEANDO PHONE NO : 954-575-1076
7407 DOVER LANE SE DECISION MADE: 21-FEB-01
PARKLAND, FL 33067 510(k) STATEMENT
DEVICE: MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPES
MEDLINE INDUSTRIES, INC. 510(k) NO: K003755(TRADITIONAL)
ATTN: LARA N SIMMONS PHONE NO : 847-949-2639
ONE MEDLINE PL. SE DECISION MADE: 16-FEB-01
MUNDELEIN, IL 60060-4486 510(k) STATEMENT
DEVICE: PROFILE II ER
MEDTOX DIAGNOSTICS, INC. 510(k) NO: K010138(SPECIAL)
ATTN: MICHAEL TURANCHIK PHONE NO : 336-226-6311
1238 ANTHONY RD. SE DECISION MADE: 14-FEB-01
BURLINGTON, NC 27215 510(k) STATEMENT
DEVICE: MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP
MEDTRONIC CARDIAC SURGICAL PRODUCT510(k) NO: K000776(TRADITIONAL)
ATTN: JAMES BALUN PHONE NO : 616-643-5283
620 WATSON S.W. SE DECISION MADE: 07-FEB-01
GRAND RAPIDS, MI 49504 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043
MEDTRONIC FUNCTIONAL DIAGNOSTICS A510(k) NO: K010130(SPECIAL)
ATTN: TOVE KJAER PHONE NO : 454 457 9000
16-18 TONSBAKKEN SE DECISION MADE: 07-FEB-01
SKOVLUNDE, DENMARK DK-2740 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES
MEDTRONIC PS MEDICAL 510(k) NO: K003914(ABBREVIATED)
ATTN: JANET MCAULEY PHONE NO : 805-968-1546
125 CREMONA DR. SE DECISION MADE: 22-FEB-01
GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TITANIUM CEMENT RESTRICTOR (TCR)
MEDTRONIC SOFAMOR DANEK 510(k) NO: K003718(TRADITIONAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-344-0807
1800 PYRAMID PLACE SE DECISION MADE: 14-FEB-01
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K010249(SPECIAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 23-FEB-01
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STYLET KIT, MODELS 6254,6282,6293
MEDTRONIC, INC. 510(k) NO: K003535(TRADITIONAL)
ATTN: KAREN CLEMENT PHONE NO : 763-514-9933
4000 LEXINGTON AVE., NORTH SE DECISION MADE: 08-FEB-01
SHOREVIEW, MN 55126-2893 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVEAL PLUS INSERTABLE LOOP RECORDER
MEDTRONIC, INC. 510(k) NO: K003667(TRADITIONAL)
ATTN: STACEY P WESSMAN PHONE NO : 763-514-9840
7000 CENTRAL AVENUE N.E. SE DECISION MADE: 14-FEB-01
MINNEAPOLIS, MN 55432-3576 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460
METRON MEDICAL AUSTRALIA P/L 510(k) NO: K003260(SPECIAL)
ATTN: ROB HOPKINS PHONE NO : 039 775 1234
57 ASTER AVE. SE DECISION MADE: 22-FEB-01
CARRUM DOWNS, VICTORIA, AUSTRALIA 510(k) STATEMENT
DEVICE: SONIC MODEL SO-300
METRON MEDICAL AUSTRALIA P/L 510(k) NO: K010102(SPECIAL)
ATTN: ROB HOPKINS PHONE NO : 613 977 51234
57 ASTER AVE. SE DECISION MADE: 09-FEB-01
CARRUM DOWNS, VICTORIA, AUSTRALIA 510(k) STATEMENT
DEVICE: FLOWRIDER FLOW DIRECTED MICRO CATHETER, MODEL 105-5065
MICRO THERAPEUTICS, INC. 510(k) NO: K010004(SPECIAL)
ATTN: EBEN GORDEN PHONE NO : 949-837-3700
2 GOODYEAR SE DECISION MADE: 13-FEB-01
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCOPE-STAINLESS STEEL/FIBER OPTIC: .5-2.6MM MODEL MMD 4500
MICRO-MEDICAL DEVICES, INC. 510(k) NO: K003695(TRADITIONAL)
ATTN: GEORGE COLEMAN PHONE NO : 216-229-8332
11000 CEDAR AVENUE SE DECISION MADE: 14-FEB-01
SUITE 445 510(k) SUMMARY AVAILABLE FROM FDA
CLEVELAND, OH 44106
DEVICE: MITEK 2GII MENISCAL REPAIR SYSTEM
MITEK PRODUCTS 510(k) NO: K002406(TRADITIONAL)
ATTN: CAROL CHAOUI PHONE NO : 781-251-2700
249 VANDERBILT AVE. SE DECISION MADE: 15-FEB-01
NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHS-63 PEDIATRIC HEAD AND SPINE ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K003655(TRADITIONAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DRIVE SE DECISION MADE: 02-FEB-01
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: HRH-127 HEAD ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K010140(TRADITIONAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DRIVE SE DECISION MADE: 22-FEB-01
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: CURRY MULTIMODAL NEUROIMAGING SOFTWARE
NEUROSOFT, INC. 510(k) NO: K001781(TRADITIONAL)
ATTN: DAVID B JONES PHONE NO : 915-845-5600
5700 CROMO DRIVE SE DECISION MADE: 05-FEB-01
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
EL PASO, TX 79912
DEVICE: TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018
NEW ENGLAND MEDICAL CORP. 510(k) NO: K002042(TRADITIONAL)
ATTN: STEVEN FODOR PHONE NO : 845-778-4200
2274 ALBANY POST RD. SE DECISION MADE: 01-FEB-01
WALDEN, NY 12586 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORG-9200A
NIHON KOHDEN AMERICA, INC. 510(k) NO: K002068(TRADITIONAL)
ATTN: BONNIE BISHOP PHONE NO : 949-580-1555
90 ICON STREET SE DECISION MADE: 08-FEB-01
FOOTHILL RANCH, CA 92610 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFE-POINT VAC, SAFE-POINT M-D BLOOD COLLECTION SYSTEMS
NORTH AMERICAN MEDICAL PRODUCTS, I510(k) NO: K001965(TRADITIONAL)
ATTN: ARTHUR GIANAKOS PHONE NO : 518-218-0402
3 WALKER WAY SE DECISION MADE: 02-FEB-01
ALBANY, NY 12205 510(k) STATEMENT
DEVICE: COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX
NOVARTIS NUTRITION CORP. 510(k) NO: K001916(TRADITIONAL)
ATTN: SHARON MARTIN PHONE NO : 612-591-2976
5320 WEST 23RD STREET SE DECISION MADE: 16-FEB-01
PO BOX 370 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55440
DEVICE: SELECT SEED I-125
NUCLETRON CORPORATION 510(k) NO: K002429(TRADITIONAL)
ATTN: ROBERT APPLEBAUM PHONE NO : 410-312-4103
7080 COLUMBIA GATEWAY DRIVE SE DECISION MADE: 02-FEB-01
COLUMBIA, MD 21046 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUF
OCU-EASE OPTICAL PRODUCTS, INC. 510(k) NO: K003996(TRADITIONAL)
ATTN: CHARLES R VERMETTE PHONE NO : 800-521-8984
629 TENNENT AVE SE DECISION MADE: 21-FEB-01
PINOLE, CA 94564 510(k) STATEMENT
DEVICE: OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOX
OCU-EASE OPTICAL PRODUCTS, INC. 510(k) NO: K004000(TRADITIONAL)
ATTN: CHARLES R VERMETTE PHONE NO : 800-521-8984
629 TENNENT AVE SE DECISION MADE: 21-FEB-01
PINOLE, CA 94564 510(k) STATEMENT
DEVICE: OLYMPUS ENDOSCOPIC LIGATION DEVICE
OLYMPUS AMERICA, INC. 510(k) NO: K001744(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
TWO CORPORATE CENTER DR. SE DECISION MADE: 27-FEB-01
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SALUTE
ONUX MEDICAL, INC. 510(k) NO: K003522(TRADITIONAL)
ATTN: GREGORY E SANCOFF PHONE NO : 603-929-6200
5 MERRILL DR. SE DECISION MADE: 13-FEB-01
HAMPTON, NH 03842 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE
OPTOVENT AB 510(k) NO: K003704(TRADITIONAL)
ATTN: CLAES RYMOND PHONE NO : 201-224-3688
1350 15TH STREET, SUITE 4H SE DECISION MADE: 05-FEB-01
FORT LEE, NJ 07024 510(k) STATEMENT
DEVICE: PROCLUDE-SENSITIVE
ORTEK THERAPEUTICS, INC. 510(k) NO: K003482(TRADITIONAL)
ATTN: JULES T MITCHEL PHONE NO : 212-681-2100
305 MADISON AVENUE SE DECISION MADE: 01-FEB-01
SUITE 2501 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10165
DEVICE: LIVESURE THC SCREEN TEST
PAN PROBE, INC. 510(k) NO: K010001(TRADITIONAL)
ATTN: ALICE H YU PHONE NO : 858-689-9936
8515 ARJONS DR., SUITE A SE DECISION MADE: 05-FEB-01
SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FLUOROPERM 151-OK, PARAGON HDS 100-OK
PARAGON VISION SCIENCES 510(k) NO: K010109(TRADITIONAL)
ATTN: WILLIAM E MEYERS PHONE NO : 480-507-7606
947 EAST IMPALA AVE. SE DECISION MADE: 28-FEB-01
MESA, AZ 85204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARE ENDOSCOPIC SUTURING SYSTEM
PARE SURGICAL, INC. 510(k) NO: K003102(TRADITIONAL)
ATTN: RICHARD P FLEENOR PHONE NO : 303-689-0187
7332 SOUTH ALTON WAY, UNIT H SE DECISION MADE: 27-FEB-01
ENGLEWOOD, CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LA
PERUSAHAAN GETAH ASAS SDN BHD 510(k) NO: K003737(TRADITIONAL)
ATTN: TAN KONG CHANG PHONE NO : 603 391 1949
LOT 754, JALAN HAJI SIRAT SE DECISION MADE: 01-FEB-01
SELANGOR, MALAYSIA 41720 510(k) STATEMENT
DEVICE: MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175
PHAMATECH 510(k) NO: K003858(TRADITIONAL)
ATTN: CARL A MONGIOVI PHONE NO : 858-635-5840
9520 PADGETT STREET #101 SE DECISION MADE: 12-FEB-01
SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANNULATED SCREW SYSTEM
PIONEER LABORATORIES, INC. 510(k) NO: K003496(TRADITIONAL)
ATTN: AMY H MOMMAERTS PHONE NO : 906-226-9909
375 RIVER PARK CIRCLE SE DECISION MADE: 08-FEB-01
MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY
POLYMER TECHNOLOGY 510(k) NO: K003932(TRADITIONAL)
ATTN: NANCY ABRAHAM PHONE NO : 716-338-8227
1400 N GOODMAN STREET SE DECISION MADE: 16-FEB-01
ROCHESTER, NY 14603-0450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY
POLYMER TECHNOLOGY 510(k) NO: K003933(TRADITIONAL)
ATTN: NANCY ABRAHAM PHONE NO : 716-338-8227
1400 N GOODMAN STREET SE DECISION MADE: 16-FEB-01
ROCHESTER, NY 14603-0450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENVIVE MINIFORMS
PROCTER & GAMBLE CO. 510(k) NO: K003843(TRADITIONAL)
ATTN: KATHLEEN C BLIEZNER PHONE NO : 513-634-3265
6110 CENTER HILL AVENUE SE DECISION MADE: 08-FEB-01
CINCINNATI, OH 45224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION G
PWA INDUSTRIES SDN. BHD. 510(k) NO: K010077(TRADITIONAL)
ATTN: K. KARUNAKARAN PHONE NO : 001 609 5670835
LOT 93, SEMAMBU INDUST. ESTATE SE DECISION MADE: 28-FEB-01
KUANTAN, PAHANG, MALAYSIA 25350 510(k) STATEMENT
DEVICE: COMFOR-CLINER
RECLINER CARE, INC. 510(k) NO: K010194(TRADITIONAL)
ATTN: MARK D BROWN PHONE NO : 210-496-0915
122 AVENIDA DEL SOL SE DECISION MADE: 15-FEB-01
SAN ANTONIO, TX 78232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REMVIEW SLEEP RECORDER, MODEL 320
RESPIRONICS, INC. 510(k) NO: K003499(ABBREVIATED)
ATTN: DAVID J VANELLA PHONE NO : 724-733-5866
1001 MURRY RIDGE LANE SE DECISION MADE: 09-FEB-01
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COBAS INTEGRA AMPHETAMINES
ROCHE DIAGNOSTICS CORP. 510(k) NO: K003865(TRADITIONAL)
ATTN: JENNIFER TRIBBETT PHONE NO : 317-576-3742
9115 HAGUE RD. SE DECISION MADE: 28-FEB-01
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS HCG+B CALCHECK
ROCHE DIAGNOSTICS CORP. 510(k) NO: K010237(TRADITIONAL)
ATTN: HELEN T TORNEY PHONE NO : 317-576-7643
9115 HAGUE RD. SE DECISION MADE: 14-FEB-01
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WRISTWATCH BLOOD PRESSURE MONITOR, MODEL A43
ROSSMAX INTERNATIONL LTD. 510(k) NO: K010190(SPECIAL)
ATTN: MICHAEL YEH PHONE NO : 011 886 226597888
12F, NO. 189, KANG CHIEN RD. SE DECISION MADE: 08-FEB-01
TAIPEI, CHINA (TAIWAN) 114 510(k) STATEMENT
DEVICE: RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM
RUSCH INTL. 510(k) NO: K010068(ABBREVIATED)
ATTN: KARENANN J BROZOWSKI PHONE NO : 603-532-7706
50 PLANTATION DRIVE SE DECISION MADE: 08-FEB-01
JAFFERY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LC PROVIFILL
S & C POLYMER GMBH 510(k) NO: K010012(TRADITIONAL)
ATTN: JURGEN ENGELBRECHT PHONE NO : 004 941 214830
ROBERT-BOSCH-STRASSE 5 SE DECISION MADE: 14-FEB-01
ELMSHORN, GERMANY D-25335 510(k) STATEMENT
DEVICE: THERMO TEK IR FOREHEAD THERMOMETER, MODEL 718F
S.A.A.T., LTD. 510(k) NO: K002712(TRADITIONAL)
ATTN: SHOSHANA FRIEDMAN PHONE NO : 972 977 18130
117 AHUZAH ST. SE DECISION MADE: 08-FEB-01
PUSH-MED LTD 510(k) SUMMARY AVAILABLE FROM FDA
RA'ANANNA, ISRAEL 43373
DEVICE: MODEL THERMO TEK QUICKCARE
SAAT LTD. 510(k) NO: K010502(TRADITIONAL)
ATTN: E. J SMITH PHONE NO : 410-451-0639
1468 HARWELL AVENUE SE DECISION MADE: 27-FEB-01
CROFTON,, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NONSTERILE POWDERED PURPLE LATEX EXAMINATION GLOVES, WITH & WITH
SGMP CO., LTD. 510(k) NO: K010095(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 09-FEB-01
SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHANGHAI CHINASTAR POWER-FREE BLUE NITRIL EXAMINATION GLOVES
SHANGHAI CHINASTAR CORP. 510(k) NO: K010247(TRADITIONAL)
ATTN: LEE HUNG TE CHIH PHONE NO : 886 227 138677
NO. 283, CHE XING ROAD SE DECISION MADE: 06-FEB-01
CHE DUN ZHEN,SONG JIANG COUNTY 510(k) SUMMARY AVAILABLE FROM FDA
SHANGHAI, CHINA THIRD PARTY REVIEW
DEVICE: ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-220
SHIMADZU MEDICAL SYSTEMS 510(k) NO: K003514(TRADITIONAL)
ATTN: MASAAKI SHIBATA PHONE NO : 310-217-8855
20101 SOUTH VERMONT AVE. SE DECISION MADE: 12-FEB-01
TORRANCE, CA 90502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-120
SHIMADZU MEDICAL SYSTEMS 510(k) NO: K003515(TRADITIONAL)
ATTN: MASAAKI SHIBATA PHONE NO : 310-217-8855
20101 SOUTH VERMONT AVE. SE DECISION MADE: 12-FEB-01
TORRANCE, CA 90502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REGUTHERM 952 THERMOGRAPHIC SYSTEM
SIE-MED, INC. 510(k) NO: K003130(TRADITIONAL)
ATTN: CHARLES H KYPER PHONE NO : 301-776-3546
11902 SIMPSON ROAD SE DECISION MADE: 16-FEB-01
CLARKSVILLE, MD 21029 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPDIMA
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K003945(TRADITIONAL)
ATTN: PRAVEEN NADKARNI PHONE NO : 732-321-4950
186 WOOD AVENUE SOUTH SE DECISION MADE: 02-FEB-01
ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORBITER II CCI/SPECT ORBITER I
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K010137(SPECIAL)
ATTN: RONALD NOLTE PHONE NO : 847-304-7504
2501 NORTH BARRINGTON RD. SE DECISION MADE: 13-FEB-01
HOFFMAN ESTATES, IL 60195-7372 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTROSTATIC HYDROPHOBIC BREATHING FILTER
SIMS PORTEX, INC. 510(k) NO: K002201(TRADITIONAL)
ATTN: TIMOTHY J TALCOTT PHONE NO : 603-352-3812
10 BOWMAN DR. SE DECISION MADE: 05-FEB-01
KEENE, NH 03431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS
SMITH & NEPHEW, INC. 510(k) NO: K003566(TRADITIONAL)
ATTN: DAVID HENLEY PHONE NO : 901-399-6487
1450 E. BROOKS ROAD SE DECISION MADE: 14-FEB-01
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYONICS CONTROL RF SYSTEM
SMITH & NEPHEW, INC. 510(k) NO: K003572(TRADITIONAL)
ATTN: MARK KIERAS PHONE NO : 978-749-1121
160 DASCOMB RD. SE DECISION MADE: 15-FEB-01
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW SUTURE ANCHOR
SMITH & NEPHEW, INC. 510(k) NO: K003599(TRADITIONAL)
ATTN: WILLIAM MCCALLUM PHONE NO : 508-261-3620
160 DASCOMB RD. SE DECISION MADE: 15-FEB-01
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048; DYONI
SMITH & NEPHEW, INC. 510(k) NO: K003710(TRADITIONAL)
ATTN: JANICE HASELTON PHONE NO : 978-749-1494
160 DASCOMB RD. SE DECISION MADE: 02-FEB-01
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOSITE HAND-CARRIED ULTRASOUND SYSTEM
SONOSITE,INC. 510(k) NO: K010374(TRADITIONAL)
ATTN: MICHAEL A HOFFMAN PHONE NO : 425-951-1297
21919 30TH DRIVE SE. SE DECISION MADE: 21-FEB-01
BOTHELL, WA 98021-3904 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SPECIALTY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
SPECIALTY ULTRAVISION, INC. 510(k) NO: K003526(TRADITIONAL)
ATTN: GAROLD L EDWARDS PHONE NO : 408-341-0700
307 ORCHARD CITY DRIVE SE DECISION MADE: 12-FEB-01
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
CAMPBELL, CA 95008
DEVICE: SPECIALITY 56 UV (HEFILCON C) SOFT (HYDROPHILLIC) CONTACT LENS F
SPECIALTY ULTRAVISION, INC. 510(k) NO: K003789(TRADITIONAL)
ATTN: DEBBIE MCINTIRE PHONE NO : 408-341-0700
307 ORCHARD CITY DRIVE SE DECISION MADE: 21-FEB-01
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
CAMPBELL, CA 95008
DEVICE: ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055
ST. FRANCIS MEDICAL EQUIPMENT CO.,510(k) NO: K003423(TRADITIONAL)
ATTN: FRANCIS HONG PHONE NO : 886 222 781555
P.O. BOX 129 SE DECISION MADE: 22-FEB-01
SHIEN CHUANG 24299 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI SHIEN, TAIWAN, R.O.C., CHINA (TAIWAN)
DEVICE: PROTRACT PRESS FIT HIP STEM-HA COATED
STELKAST CO. 510(k) NO: K010241(SPECIAL)
ATTN: DONALD A STEVENS PHONE NO : 412-322-8280
800 VINIAL ST. #210 SE DECISION MADE: 08-FEB-01
PITTSBURGH, PA 15212 510(k) STATEMENT
DEVICE: LATERAL OFFSET PROTRACT PRESS FIT HIP STEM
STELKAST CO. 510(k) NO: K010282(SPECIAL)
ATTN: DONALD A STEVENS PHONE NO : 412-322-8280
800 VINIAL ST. #210 SE DECISION MADE: 09-FEB-01
PITTSBURGH, PA 15212 510(k) STATEMENT
DEVICE: VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 6000
STERINC 510(k) NO: K002912(TRADITIONAL)
ATTN: GARY FRUGARD PHONE NO : 949-493-5829
3520 W. WARNER AVENUE SE DECISION MADE: 21-FEB-01
SANTA ANTA, CA 92704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CROSS-CHECKS LF, MODEL CI 119/S &CI; 119/L
STERITEC PRODUCTS, INC. 510(k) NO: K003533(ABBREVIATED)
ATTN: LINDA NELSON PHONE NO : 303-660-4201
599 TOPEKA WAY, SUITE 700 SE DECISION MADE: 07-FEB-01
CASTLE ROCK, CO 80104 510(k) STATEMENT
DEVICE: STRYKER HEATED INSUFFLATOR TUBE SET
STRYKER CORP. 510(k) NO: K003792(TRADITIONAL)
ATTN: MICHAEL BAYCURA PHONE NO : 408-567-9100
2590 WALSH AVE. SE DECISION MADE: 21-FEB-01
SANTA CLARA, CA 95051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANATOMICAL PRESS-FIT HUMERAL STEM
SULZER ORTHOPEDICS, INC. 510(k) NO: K003801(TRADITIONAL)
ATTN: MITCHELL A DHORITY PHONE NO : 512-432-9202
9900 SPECTRUM DR. SE DECISION MADE: 28-FEB-01
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILE POWDERED LATEX SURGEON GLOVES
SUPERMAX GLOVE MANUFACTURING SDN B510(k) NO: K010198(TRADITIONAL)
ATTN: STANLEY THAI PHONE NO : 603 615 72328
47000 SUNGAI BULOH SE DECISION MADE: 23-FEB-01
SELANGOR, MALAYSIA 510(k) STATEMENT
DEVICE: SURGI-VISION GUIDEWIRE COIL
SURGI-VISION, INC. 510(k) NO: K003436(TRADITIONAL)
ATTN: NANCY E TALOR PHONE NO : 410-730-8998
9250 RUMSEY RD., SUITE 100 SE DECISION MADE: 02-FEB-01
COLUMBIA, MD 21045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIRSTSAVE BIPHASIC MODEL #9200 AND 9210
SURVIVALINK CORP. 510(k) NO: K010214(SPECIAL)
ATTN: SEW-WAH TAY PHONE NO : 952-939-4181
5420 FELTL RD. SE DECISION MADE: 22-FEB-01
MINNEAPOLIS, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINIENDO III
SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K003640(TRADITIONAL)
ATTN: COLLEEN BOSELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 22-FEB-01
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERMLASTIC 3
SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K003650(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 15-FEB-01
ORANGE, CA 92667 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUISPX HDL/LDL LIQUID CHOLESTEROL CALIBRATOR
SYNERGENT BIOCHEM INC.-CLINICAL CO510(k) NO: K010030(TRADITIONAL)
ATTN: JAMES F GODFREY PHONE NO : 800-585-8580
12038 CENTRAILIA AVE SE DECISION MADE: 14-FEB-01
SUITE C 510(k) SUMMARY AVAILABLE FROM FDA
HAWAIIAN GARDENS, CA 90716
DEVICE: SYNTHES HAMSTRING LOOP
SYNTHES (USA) 510(k) NO: K003700(TRADITIONAL)
ATTN: THOMAS M MAGUIRE PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 20-FEB-01
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES MODIFIED BIORESORBABLE SUTURE ANCHOR SYSTEM
SYNTHES (USA) 510(k) NO: K003743(TRADITIONAL)
ATTN: ANGELA J SILVESTRI PHONE NO : 610-647-9700
1690 RUSSELL ROAD SE DECISION MADE: 09-FEB-01
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMF RESORBABLE MESHES AND SHEETS
SYNTHES (USA) 510(k) NO: K003786(TRADITIONAL)
ATTN: THOMAS M MAGUIRE PHONE NO : 610-647-9700
P.O. BOX 1766 SE DECISION MADE: 27-FEB-01
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301-1222
DEVICE: STERILE BUTTON PLATE
SYNTHES (USA) 510(k) NO: K010121(SPECIAL)
ATTN: THOMAS M MAGUIRE PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 09-FEB-01
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAUT-INSUFFLATION NEEDLE
TAUT, INC. 510(k) NO: K003703(TRADITIONAL)
ATTN: RONALD KENSETH PHONE NO : 630-232-2507
2571 KANEVILLE COURT SE DECISION MADE: 22-FEB-01
GENEVA, IL 60134 510(k) STATEMENT
DEVICE: ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP
TAUT, INC. 510(k) NO: K010007(TRADITIONAL)
ATTN: RONALD KENSETH PHONE NO : 630-232-8005
2571 KANEVILLE COURT SE DECISION MADE: 22-FEB-01
GENEVA, IL 60134 510(k) STATEMENT
DEVICE: TE ME NA EPIDURAL CATHETER
TE ME NA S.A.R.L. 510(k) NO: K991259(TRADITIONAL)
ATTN: ARTHUR WARD PHONE NO : 813-645-2855
390 SCARLET BLVD SE DECISION MADE: 21-FEB-01
OLDSMAR, FL 34677 510(k) STATEMENT
DEVICE: A & I WHEELCHAIRS
TECH-MED SERVICES, INC. 510(k) NO: K010094(TRADITIONAL)
ATTN: RICHARD GRAVER PHONE NO : 631-582-7320
933A MOTOR PARKWAY SE DECISION MADE: 15-FEB-01
HAUPPAQUE, NY 11788 510(k) STATEMENT
DEVICE: TENSCARE, MODEL TENS XL-2
TENS CARE LTD. 510(k) NO: K003591(TRADITIONAL)
ATTN: BERNARD J TREMAINE PHONE NO : 441 019 804310
76, STOCKPORT ROAD SE DECISION MADE: 14-FEB-01
TIMPERLRY, UNITED KINGDOM WA15 7SN510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MTP RESESURFACING JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE/930
TERRAY CORP. 510(k) NO: K003629(TRADITIONAL)
ATTN: STEVE WANG PHONE NO : 613 623 3310
49 JACKSON LANE SE DECISION MADE: 22-FEB-01
ARNPRIOR, CANADA K7S3G8 510(k) STATEMENT
DEVICE: ADAPTERS WITH X-COATING
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K003604(TRADITIONAL)
ATTN: GARRY A COURTNEY PHONE NO : 800-283-7866
125 BLUE BALL ROAD SE DECISION MADE: 07-FEB-01
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLIRANS E-SERIES HOLLOW FIBER DIALYZERS
TERUMO MEDICAL CORPORATION 510(k) NO: K003425(TRADITIONAL)
ATTN: YUK-TING LEWIS PHONE NO : 410-392-7213
125 BLUE BALL ROAD SE DECISION MADE: 01-FEB-01
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML S
TERUMO MEDICAL CORPORATION 510(k) NO: K003571(ABBREVIATED)
ATTN: BARBARA SMITH PHONE NO : 410-392-7241
125 BLUE BALL ROAD SE DECISION MADE: 12-FEB-01
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KAPPA IMMAGE FREELITE KIT
THE BINDING SITE, LTD. 510(k) NO: K003669(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
WEST TOWER, SUITE 4000 SE DECISION MADE: 01-FEB-01
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: LAMBDA IMMAGE FREELITE KIT
THE BINDING SITE, LTD. 510(k) NO: K003671(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
WEST TOWER, SUITE 4000 SE DECISION MADE: 01-FEB-01
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: ANA EIA DIAGNOSTIC TEST KIT
THE BINDING SITE, LTD. 510(k) NO: K004019(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
WEST TOWER, SUITE 4000 SE DECISION MADE: 15-FEB-01
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: ENA SCREEN EIA KIT
THE BINDING SITE, LTD. 510(k) NO: K010148(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
WEST TOWER, SUITE 4000 SE DECISION MADE: 23-FEB-01
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: ACTICOAT FOAM DRESSING, ALGISITE M CALCIUM ALGINATE DRESSING
THE WESTAIM CORP. 510(k) NO: K002896(TRADITIONAL)
ATTN: STEVEN CHARTIER PHONE NO : 603-775-7300
1 HAMPTON RD., #302 SE DECISION MADE: 21-FEB-01
EXETER, NH 03833-4807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSIGRIP LTC POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN C
TILLOTSON HEALTHCARE CORPORATION 510(k) NO: K004048(TRADITIONAL)
ATTN: F.W. PERRELLA PHONE NO : 603-472-6600
360 ROUTE 101 SE DECISION MADE: 06-FEB-01
BEDFORD, NH 03110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALFIQUE ESTELITE LV CLEAR
TOKUYAMA AMERICA, INC. 510(k) NO: K010267(TRADITIONAL)
ATTN: DANIEL J MANELLI PHONE NO : 202-261-1040
2000 M STREET (SUITE 700) SE DECISION MADE: 27-FEB-01
WASHINGTON, DC 20036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING
TOMTEC IMAGING SYSTEMS, GMBH 510(k) NO: K003936(TRADITIONAL)
ATTN: FLORIAN EISENBERGER PHONE NO : 011 49 8932175830
EDISONSTRASSE 6 SE DECISION MADE: 14-FEB-01
UNTERSCHLEISSHEIM, GERMANY D-85716510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
TOTAL WATER TREATMENT SYSTEMS, INC510(k) NO: K002045(TRADITIONAL)
ATTN: KENNETH J CLARK PHONE NO : 608-221-2236
4806 EAST BROADWAY SE DECISION MADE: 16-FEB-01
MADISON, WI 53716 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K003834(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-216-9036
29299 CLEMENS RD., SUITE 1-K SE DECISION MADE: 23-FEB-01
WESTLAKE, OH 44145 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSITIRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K003868(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-216-9036
29299 CLEMENS RD., SUITE 1-K SE DECISION MADE: 27-FEB-01
WESTLAKE, OH 44145 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870
TUTTNAUER CO. LTD. 510(k) NO: K003470(ABBREVIATED)
ATTN: MARK YACURA PHONE NO : 202-452-7949
1776 K STREET N.W. SE DECISION MADE: 20-FEB-01
SUITE 800 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20006-2365
DEVICE: TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP
TUTTNAUER USA CO. LTD. 510(k) NO: K993856(TRADITIONAL)
ATTN: MARK M YACURA PHONE NO : 202-452-7949
1776 K STREET, N.W. SE DECISION MADE: 09-FEB-01
SUITE 800 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20006-7910
DEVICE: PALMLIGHT
ULTRADENT PRODUCTS, INC. 510(k) NO: K003383(TRADITIONAL)
ATTN: MARKUS R GEE PHONE NO : 800-552-5512
505 WEST 10200 SOUTH SE DECISION MADE: 06-FEB-01
SOUTH JORDAN, UT 84065 510(k) STATEMENT
DEVICE: MODIFICATION TO CAVERMAP SURGICAL AID
UROMED CORP. 510(k) NO: K010098(SPECIAL)
ATTN: FREDERICK TOBIA PHONE NO : 781-762-2080
1400 PROVIDENCE HWY. SE DECISION MADE: 01-FEB-01
NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTALVISION
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K003636(TRADITIONAL)
ATTN: LINDA S NASH PHONE NO : 650-424-6990
3100 HANSEN WAY SE DECISION MADE: 02-FEB-01
PALO ALTO, CA 94304-1129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASCULAR ARCHITECTS PERISCOPE DEVICE
VASCULAR ARCHITECTS, INC. 510(k) NO: K003719(TRADITIONAL)
ATTN: JEAN M CAILLOUETTE PHONE NO : 408-392-7437
1830 BERING DR. SE DECISION MADE: 28-FEB-01
SAN JOSE, CA 95112-4226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM
VIDAMED, INC. 510(k) NO: K002583(TRADITIONAL)
ATTN: TOM MCGAFFIGAN PHONE NO : 510-492-4930
46107 LANDING PKWY. SE DECISION MADE: 13-FEB-01
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500
VISUALIZATION TECHNOLOGY, INC. 510(k) NO: K003510(TRADITIONAL)
ATTN: NORMA LEMAY PHONE NO : 978-933-1000
200 RESEARCH DR. SE DECISION MADE: 12-FEB-01
WILMINGTON, MA 01887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONYX-RAD TELEMEDICINE PACS
VIZTEK, INC. 510(k) NO: K003607(TRADITIONAL)
ATTN: JOSIP CERMIN PHONE NO : 904-733-3656
6491 POWERS AVE. SE DECISION MADE: 15-FEB-01
JACKSONVILLE, FL 32217 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERCUSSIVENEB, MODEL PN-2001
VORTRAN MEDICAL TECHNOLOGY 1, INC.510(k) NO: K003684(SPECIAL)
ATTN: GORDON A WONG PHONE NO : 916-733-6870
3941 J ST., SUITE 354 SE DECISION MADE: 23-FEB-01
SACRAMENTO, CA 95819 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)
W & H DENTALWERK BUERMOOS GMBH 510(k) NO: K002469(TRADITIONAL)
ATTN: HERBERT TRASCHWANDTNER PHONE NO : 011 436 27462360
IGNAZ GLASER STR. 53 SE DECISION MADE: 07-FEB-01
A-5111 510(k) STATEMENT
BUERMOOS, AUSTRIA A-5111
DEVICE: GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
W.L. GORE & ASSOCIATES,INC 510(k) NO: K010228(SPECIAL)
ATTN: R. LARRY PRATT PHONE NO : 800-528-1866
3750 WEST KILTIE LN. SE DECISION MADE: 21-FEB-01
FLAGSTAFF, AZ 86002-0900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DELFIA NEONATAL IRT KIT, MODEL A005-110
WALLAC OY 510(k) NO: K003664(TRADITIONAL)
ATTN: GUNNEL LAAKSONEN PHONE NO : 358 226 78111
MUSTIONKATU 6 SE DECISION MADE: 14-FEB-01
TURKU, FINLAND 20750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTODELFIA NEONATAL IRT KIT, MODEL B005-112
WALLAC OY 510(k) NO: K003668(TRADITIONAL)
ATTN: GUNNEL LAAKSONEN PHONE NO : 358 226 78111
MUSTIONKATU 6 SE DECISION MADE: 12-FEB-01
TURKU, FINLAND 20750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LORENZ RESORBABLE DISTRACTOR SYSTEM
WALTER LORENZ SURGICAL, INC. 510(k) NO: K002083(TRADITIONAL)
ATTN: STEVE HERRINGTON PHONE NO : 904-741-4400
1520 TRADEPORT DR. SE DECISION MADE: 12-FEB-01
JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE
WANDY RUBBER INDUSTRIAL CO., LTD 510(k) NO: K002219(TRADITIONAL)
ATTN: JANIS YANG PHONE NO : 886 269 43184
NO. 22, ALLAY 37, LANE 266 SE DECISION MADE: 02-FEB-01
FU TEH I RD. 510(k) STATEMENT
SHI-CHIH, TAIPEI, CHINA (TAIWAN)
DEVICE: WANDY SILICONE CONDUCTIVE RUBBER PAD
WANDY RUBBER INDUSTRIAL CO., LTD 510(k) NO: K002227(TRADITIONAL)
ATTN: JANIS YANG PHONE NO : 886 269 43184
NO. 22, ALLAY 37, LANE 266 SE DECISION MADE: 02-FEB-01
FU TEH I RD. 510(k) STATEMENT
SHI-CHIH, TAIPEI, CHINA (TAIWAN)
DEVICE: CLEAN SCRAPE
WEBB RESEARCH II, INC. 510(k) NO: K003773(TRADITIONAL)
ATTN: STEVEN KRUPNICK PHONE NO : 215-336-5570
1241 CARPENTER STREET SE DECISION MADE: 02-FEB-01
PHILADELPHIA, PA 19147 510(k) STATEMENT
DEVICE: ACTICOAT COMPOSITE DRESSING
WESTAIM BIOMEDICAL, INC. 510(k) NO: K002466(TRADITIONAL)
ATTN: STEVE CHARTIER PHONE NO : 603-775-7300
ONE HAMPTON RD. SUITE 302 SE DECISION MADE: 16-FEB-01
EXETER, NH 03833 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENGPLUS
WESTERN SYSTEMS RESEARCH, INC. 510(k) NO: K010059(TRADITIONAL)
ATTN: LINDA DAVIS-O'LEARY PHONE NO : 626-578-7363
260 S. LOS ROBLES AVE. STE 106 SE DECISION MADE: 27-FEB-01
PASADENA, CA 91101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERFECTA AND EXTEND
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K004032(ABBREVIATED)
ATTN: EHAB M ESMAIL PHONE NO : 901-867-4732
5677 AIRLINE RD. SE DECISION MADE: 15-FEB-01
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER
ZCV ,INC. 510(k) NO: K010099(SPECIAL)
ATTN: JING ZHANG PHONE NO : 732-225-3800
298 FERNWOOD AVE. SE DECISION MADE: 01-FEB-01
EDISON, NJ 08837 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIOLOGY ACETABULAR SYSTEM 46MM LARGE HEAD LINERS, MODEL 6310
ZIMMER, INC. 510(k) NO: K003478(TRADITIONAL)
ATTN: KAREN CAIN PHONE NO : 219-372-4219
P.O. BOX 708 SE DECISION MADE: 05-FEB-01
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZOLL M SERIES
ZOLL MEDICAL CORP. 510(k) NO: K010257(SPECIAL)
ATTN: PAUL DIAS PHONE NO : 781-229-0020
32 SECOND AVE. SE DECISION MADE: 28-FEB-01
BURLINGTON, MA 01803 510(k) STATEMENT
TOTAL 510(k)s THIS PERIOD 265
TOTAL WITH SUMMARIES 190
TOTAL WITH STATEMENTS 75
Updated 5/10/2002
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