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510(k)s Final Decisions Rendered for January 2002 |
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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-JAN-2002 THROUGH 31-JAN-2002
DEVICE: EVTOOL MODEL # V. 1.0
3D LINE USA, INC. 510(k) NO: K013535(TRADITIONAL)
ATTN: KAREN RIGAMONTI PHONE NO : 410-580-1730
2807 OLD COURT ROAD SE DECISION MADE: 18-JAN-02
BALTIMORE, MD 21208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3DFIS, MODEL IES-FL-101
3DSHARP, INC. 510(k) NO: K013841(TRADITIONAL)
ATTN: DONALD KRIEGER PHONE NO : 412-648-9211
6425 FORWARD AVE. SE DECISION MADE: 17-JAN-02
PITTSBURGH, PA 15217 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHI
ADVANCED CARDIOVASCULAR SYSTEMS, I510(k) NO: K012534(TRADITIONAL)
ATTN: JOANNA MROZ PHONE NO : 408-845-3956
3200 LAKESIDE DRIVE SE DECISION MADE: 24-JAN-02
SANTA CLARA, CA 95052-8167 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009
AIRSEP CORP. 510(k) NO: K012037(TRADITIONAL)
ATTN: CHARLOTTE H HAMILTON PHONE NO : 716-691-0202
290 CREEKSIDE DR. SE DECISION MADE: 17-JAN-02
BUFFALO, NY 14228-2070 510(k) STATEMENT
DEVICE: SEAL-ON TOPICAL HEMPSTATIC POWDER SPRAY
ALLTRACEL PHARMA LTD. 510(k) NO: K010933(ABBREVIATED)
ATTN: CHARLES H KYPER PHONE NO : 919-960-0049
103 NOLEN LANE SE DECISION MADE: 08-JAN-02
CHAPEL HILL, NC 27516 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CIC-C1Q EIA
AMERICAN LABORATORY PRODUCTS CO., 510(k) NO: K012576(TRADITIONAL)
ATTN: RICHARD E CONLEY PHONE NO : 603-893-8914
P.O. BOX 451 SE DECISION MADE: 29-JAN-02
WINDHAM, NH 03087 510(k) STATEMENT
DEVICE: APEX MEDICAL MINI TENS
APEX MEDICAL CORP. 510(k) NO: K020032(SPECIAL)
ATTN: ALAN CHANG PHONE NO : 886 226 954170
10TH FL., NO. 31, LANE 169, SE DECISION MADE: 31-JAN-02
KANG NING ST. 510(k) STATEMENT
SHI-CHIH, TAIPEI HSIEN, CHINA (TAIWAN)
DEVICE: DILATING TIP OBTURATOR
APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K012884(TRADITIONAL)
ATTN: ANIL BHALANI PHONE NO : 949-713-8000
22872 AVENIDA EMPRESSA SE DECISION MADE: 17-JAN-02
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROCARE CONTROLLER, PATIENT CABLE, FOOT CONTROL, POWER CORD
ARTHROCARE CORP. 510(k) NO: K014222(SPECIAL)
ATTN: BRUCE PROTHRO PHONE NO : 408-736-0224
595 NORTH PASTORIA AVE. SE DECISION MADE: 18-JAN-02
SUNNYVALE, CA 94085-2936 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRAMAX WOVEN VELOUR VASCULAR GRAFT
ATRIUM MEDICAL CORP. 510(k) NO: K013577(TRADITIONAL)
ATTN: JOSEPH P PAOLO PHONE NO : 603-880-1433
5 WENTWORTH DR. SE DECISION MADE: 25-JAN-02
HUDSON, NH 03051 510(k) STATEMENT
DEVICE: MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX
AUGUSTINE MEDICAL, INC. 510(k) NO: K020077(SPECIAL)
ATTN: SCOTT D AUGUSTINE PHONE NO : 952-947-1200
10393 WEST 70TH ST. SE DECISION MADE: 31-JAN-02
EDEN PRAIRIE, MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FINGER JOINT PROSTHESIS
AVANTA ORTHOPAEDICS, INC. 510(k) NO: K013629(TRADITIONAL)
ATTN: LOUISE M FOCHT PHONE NO : 858-452-8580
9369 CARROLL PARK DRIVE, STE.A SE DECISION MADE: 25-JAN-02
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERIFIX SAFETY EPIDURAL NEEDLES
B. BRAUN MEDICAL, INC. 510(k) NO: K013610(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-266-0500
901 MARCON BLVD. SE DECISION MADE: 25-JAN-02
ALLENTOWN, PA 18109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORONIS 3MP MEDICL FLAT PANEL DISPLAY SYSTEM
BARCO NV 510(k) NO: K013922(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 858-587-1147
P.O. BOX 12038 SE DECISION MADE: 28-JAN-02
LA JOLLA, CA 92039-2038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA 1650 CHOLINESTERASE ASSAY
BAYER DIAGNOSTICS CORP. 510(k) NO: K013750(TRADITIONAL)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE SE DECISION MADE: 18-JAN-02
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANAL
BAYER DIAGNOSTICS CORP. 510(k) NO: K013959(TRADITIONAL)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE SE DECISION MADE: 29-JAN-02
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3420 DIGIT PULSE OXIMETER, MODEL 3420
BCI, INC. 510(k) NO: K013171(TRADITIONAL)
ATTN: DONALD ALEXANDER PHONE NO : 262-542-3100
N7 W22025 JOHNSON ROAD SE DECISION MADE: 03-JAN-02
WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CHLORIDE INJECTI
BD 510(k) NO: K011967(TRADITIONAL)
ATTN: GREGORY W MORGAN PHONE NO : 201-847-4344
1 BECTON DR. MC 226 SE DECISION MADE: 23-JAN-02
FRANKLIN LAKES, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT
BECKMAN COULTER, INC. 510(k) NO: K013978(TRADITIONAL)
ATTN: MARY BETH TANG PHONE NO : 714-961-3777
200 SOUTH KRAEMER BLVD.,W-104 SE DECISION MADE: 15-JAN-02
P.O. BOX 8000 510(k) SUMMARY AVAILABLE FROM FDA
BREA, CA 92822-8000
DEVICE: SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR
BECKMAN COULTER, INC. 510(k) NO: K014103(TRADITIONAL)
ATTN: MARY BETH TANG PHONE NO : 714-961-3777
200 SOUTH KRAEMER BLVD.,W-104 SE DECISION MADE: 28-JAN-02
BREA, CA 92822-8000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELD
BECTON DICKINSON INFUSION THERAPY 510(k) NO: K013304(TRADITIONAL)
ATTN: LESLIE WOOD PHONE NO : 801-565-2504
9450 SOUTH STATE ST. SE DECISION MADE: 02-JAN-02
SANDY, UT 84070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664
BIOCARDIA, INC. 510(k) NO: K012749(TRADITIONAL)
ATTN: DANIEL C ROSENMAN PHONE NO : 650-624-0120
384 OYSTER POINT BLVD. #6 SE DECISION MADE: 24-JAN-02
SOUTH SAN FRANCISCO, CA 94080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT
BIOCHECK, INC. 510(k) NO: K013062(TRADITIONAL)
ATTN: ROBIN J HELLEN PHONE NO : 818-709-5646
9418 LASAINE AVE SE DECISION MADE: 08-JAN-02
NORTHRIDGE, CA 91325 510(k) STATEMENT
DEVICE: COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 00080
BIOFORM, INC. 510(k) NO: K013243(TRADITIONAL)
ATTN: VICTOR M BOWERS PHONE NO : 262-835-9800
4133 COURTNEY ROAD, #10 SE DECISION MADE: 09-JAN-02
FRANKSVILLE, WI 53126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO THE MAESTRO SYSTEM
BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K020133(SPECIAL)
ATTN: DONALD E DALTON PHONE NO : 205-967-7880
ONE PERIMETER PARK SOUTH SE DECISION MADE: 25-JAN-02
SUITE 230, SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
BIRMINGHAM, AL 35243
DEVICE: WATERLASE MILLENNIUM
BIOLASE TECHNOLOGY, INC. 510(k) NO: K012511(TRADITIONAL)
ATTN: IOANA M RIZOIU PHONE NO : 949-361-1200
981 CALLE AMANECER SE DECISION MADE: 18-JAN-02
SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOLIGHT PCD
BIOLIGHT INTERNATIONAL AB 510(k) NO: K011355(TRADITIONAL)
ATTN: CONSTANCE G BUNDY PHONE NO : 763-574-1976
6740 RIVERVIEW TERRACE SE DECISION MADE: 17-JAN-02
MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOHEX ONE-PIECE ONE STAGE DENTAL IMPLANT SYSTEM
BIOMEDICAL IMPLANT TECHNOLOGY, INC510(k) NO: K013383(TRADITIONAL)
ATTN: RODNEY J SHAUGHNESSY PHONE NO : 514 631 2649
206 KING ST. SE DECISION MADE: 10-JAN-02
ST. CATHERINES, ONTARIO, CANADA L2510(k) STATEMENT
DEVICE: 3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM
BIOMET ORTHOPEDICS, , INC. 510(k) NO: K020045(SPECIAL)
ATTN: DALENE T BINKLEY PHONE NO : 219-267-6639
P.O. BOX 587 SE DECISION MADE: 30-JAN-02
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PATRIOT PROTRUSIO CAGE
BIOMET ORTHOPEDICS, , INC. 510(k) NO: K020076(SPECIAL)
ATTN: TRACY J BICKEL PHONE NO : 219-267-6639
P.O. BOX 587 SE DECISION MADE: 30-JAN-02
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE
BIOMET, INC. 510(k) NO: K012551(TRADITIONAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 219-267-6639
56 EAST BELL SE DECISION MADE: 30-JAN-02
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46582
DEVICE: TRIAGE TOX DRUG SCREEN, CATALOG #94000
BIOSITE DIAGNOSTICS 510(k) NO: K012745(TRADITIONAL)
ATTN: JEFFREY R DAHLEN PHONE NO : 858-455-4808
11030 ROSELLE ST. SE DECISION MADE: 10-JAN-02
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMPLE
BISCO, INC. 510(k) NO: K013519(TRADITIONAL)
ATTN: STEPHEN D SMITH PHONE NO : 847-534-6146
1100 WEST IRVING PARK RD. SE DECISION MADE: 17-JAN-02
SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM
BLACKSTONE MEDICAL, INC. 510(k) NO: K012184(TRADITIONAL)
ATTN: ALAN LOMBARDO PHONE NO : 973-633-9968
90 BROOKSDALE DR. SE DECISION MADE: 30-JAN-02
SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW
BLACKSTONE MEDICAL, INC. 510(k) NO: K013558(TRADITIONAL)
ATTN: ALAN LOMBARDO PHONE NO : 973-633-9968
90 BROOKSDALE DR. SE DECISION MADE: 23-JAN-02
SPRINGFIELD, MA 01104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOEHRINGER MRI SUCTION REGULATORY
BOEHRINGER LABORATORIES 510(k) NO: K013976(TRADITIONAL)
ATTN: JOHN KARPOWICZ PHONE NO : 610-278-0900
500 E. WASHINGTON STREET SE DECISION MADE: 08-JAN-02
NORRISTOWN, PA 19401 510(k) STATEMENT
DEVICE: 6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F M
BOSTON SCIENTIFIC 510(k) NO: K020028(SPECIAL)
ATTN: TODD KORNMANN PHONE NO : 763-694-5857
ONE SCIMED PLACE SE DECISION MADE: 22-JAN-02
MAPLE GROVE, MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MATRIX DETACHABLE COILS
BOSTON SCIENTIFIC, TARGET 510(k) NO: K012985(TRADITIONAL)
ATTN: SETH A SCHULMAN PHONE NO : 510-440-7753
47900 BAYSIDE PARKWAY SE DECISION MADE: 31-JAN-02
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETER
BOSTON SCIENTIFIC/MEDI-TECH 510(k) NO: K020012(SPECIAL)
ATTN: JODI L GREENIZEN PHONE NO : 518-742-4338
ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 29-JAN-02
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JOBST READY-TO-WEAR GAUNTLET
BSN-JOBST, INC. 510(k) NO: K013852(TRADITIONAL)
ATTN: ANGELO R PEREIRA PHONE NO : 704-551-7178
5825 CARNEGIE BLVD. SE DECISION MADE: 28-JAN-02
CHARLOTTE, NC 28209-4633 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REUSE CLAIM FOR THE BARD ELECTROPHYSIOLOGY SURELINK, TEMPLINK, A
C.R. BARD, INC. 510(k) NO: K013598(TRADITIONAL)
ATTN: EBORAH L HERRINGTON PHONE NO : 978-323-2216
55 TECHNOLOGY DR. SE DECISION MADE: 11-JAN-02
LOWELL, MA 01851 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARD CONQUEST PTA BALLOON DILATATION CATHETER
C.R. BARD, INC. 510(k) NO: K014212(SPECIAL)
ATTN: CAROL VIERLING PHONE NO : 770-385-2347
13183 HARLAND DR. SE DECISION MADE: 17-JAN-02
COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31
CANON U.S.A., INC. 510(k) NO: K003689(TRADITIONAL)
ATTN: SHEILA DRISCOLL PHONE NO : 516-328-5602
ONE CANON PLAZA SE DECISION MADE: 02-JAN-02
LAKE SUCCESS, NY 11042-1198 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLOBALCARDIO
CARDIOCOMM SOLUTIONS, INC. 510(k) NO: K013354(TRADITIONAL)
ATTN: ANGELA HALWAS PHONE NO : 250 744 1822
3060 CEDAR HILL ROAD SE DECISION MADE: 31-JAN-02
SUITE 201 510(k) SUMMARY AVAILABLE FROM FDA
VICTORIA, B.C., CANADA V8T 3J5
DEVICE: HUMPHREY OCT3
CARL ZEISS OPHTHALMIC SYSTEMS, INC510(k) NO: K012727(TRADITIONAL)
ATTN: MELISSSA R HORNE PHONE NO : 925-557-4100
5160 HACIENDA DR. SE DECISION MADE: 31-JAN-02
DUBLIN, CA 94568 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WAMPOLE HS-CRP ELISA
CARTER-WALLACE, INC. 510(k) NO: K011855(TRADITIONAL)
ATTN: MAUREEN GARNER PHONE NO : 609-655-6345
P.O. BOX 1001 SE DECISION MADE: 08-JAN-02
HALF ACRE ROAD 510(k) SUMMARY AVAILABLE FROM FDA
CRANBURY, NJ 08512
DEVICE: CATHEFFECTS' DESAI VECTORCATH MAPPING SYSTEM
CATHEFFECTS, LLC. 510(k) NO: K012089(TRADITIONAL)
ATTN: SHAWN FOJTIK PHONE NO : 916-677-1790
1100 MELODY LANE; SUITE 108 SE DECISION MADE: 28-JAN-02
ROSEVILLE, CA 95678 510(k) STATEMENT
DEVICE: VENTED VIAL ACCESS DEVICE
CHURCHILL MEDICAL SYSTEMS, INC. 510(k) NO: K013950(TRADITIONAL)
ATTN: KEITH PALUCH PHONE NO : 603-743-5988
87 VENTURE DR. SE DECISION MADE: 10-JAN-02
DOVER, NH 03820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: USA SERIES LAPAROSCOPES
CIRCON ACMI 510(k) NO: K013165(TRADITIONAL)
ATTN: WAYNE B STERNER PHONE NO : 805-961-3290
300 STILLWATER AVE. SE DECISION MADE: 18-JAN-02
P.O. BOX 1971 510(k) SUMMARY AVAILABLE FROM FDA
STAMFORD, CT 06904-1971
DEVICE: DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2
CIRCON VIDEO 510(k) NO: K011876(TRADITIONAL)
ATTN: JOHN DELUCIA PHONE NO : 508-879-4835
492 OLD CONNECTICUT PATH SE DECISION MADE: 08-JAN-02
FRAMINGHAM, MA 01701-4584 510(k) STATEMENT
DEVICE: COALESCENT SURGICAL U-CLIP
COALESCENT SURGICAL 510(k) NO: K013664(TRADITIONAL)
ATTN: MICHAEL A DANIEL PHONE NO : 415-407-0223
559 EAST WEDDELL DR. SE DECISION MADE: 24-JAN-02
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IDENT-A100 INTRAORAL VIDEO CAMERA
CONFIDENT TECHNOLOGY, INC. 510(k) NO: K013690(TRADITIONAL)
ATTN: LEWIS LIN PHONE NO : 909-590-8665
13841 ROSWELL AVE. # K SE DECISION MADE: 30-JAN-02
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCENT
CONFIRMA 510(k) NO: K013574(TRADITIONAL)
ATTN: CHERYL SHEA PHONE NO : 425-576-3247
821 KIRKLAND AVENUE SE DECISION MADE: 15-JAN-02
KIRKLAND, WA 98033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-S
CONTINUUM ELECTRO-OPTICS, INC. 510(k) NO: K014234(SPECIAL)
ATTN: RONALD KOHLHARDT PHONE NO : 408-727-3240
3150 CENTRAL EXPRESSWAY SE DECISION MADE: 17-JAN-02
SANTA CLARA, CA 95051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COSMO'S COSMO TENS PF-990 MINI DIGITAL WIRELESS MASSAGE PATCH
COSMO HEALTH, INC. 510(k) NO: K013507(TRADITIONAL)
ATTN: ROBERT SCHIFF PHONE NO : 973-227-1830
1129 BLOOMFLIED AVE. SE DECISION MADE: 25-JAN-02
WEST CALDWELL, NJ 07006 510(k) STATEMENT
DEVICE: MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS
CP MEDICAL 510(k) NO: K013964(SPECIAL)
ATTN: MARY ANN GREENWALT PHONE NO : 503-232-1555
P.O. BOX 6724 SE DECISION MADE: 24-JAN-02
PORTLAND, OR 97208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOC BAND
CRANIAL TECHNOLOGIES, INC. 510(k) NO: K014012(TRADITIONAL)
ATTN: TIMOTHY R LITTLEFIELD PHONE NO : 480-505-1840
1395 WEST AUTO DR. SE DECISION MADE: 28-JAN-02
TEMPE, AZ 85284 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUI
CROSSTEX INTL. 510(k) NO: K012602(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 22-JAN-02
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N LATEX LP(A)
DADE BEHRING, INC. 510(k) NO: K013128(TRADITIONAL)
ATTN: REBECCA S AYASH PHONE NO : 302-631-6276
GLASGOW SITE SE DECISION MADE: 18-JAN-02
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714
DEVICE: DADE THROMBOPLASTIN C PLUS
DADE BEHRING, INC. 510(k) NO: K013155(TRADITIONAL)
ATTN: RADAMES RIESGO PHONE NO : 305-480-7558
13251 NW 9TH TERRACE SE DECISION MADE: 18-JAN-02
MIAMI, FL 33182 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA S/5 WEB VIEWER
DATEX-OHMEDA 510(k) NO: K013387(TRADITIONAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 08-JAN-02
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES
DATEX-OHMEDA 510(k) NO: K013389(TRADITIONAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 10-JAN-02
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER
DATEX-OHMEDA, INC. 510(k) NO: K012924(SPECIAL)
ATTN: BILL EXNER PHONE NO : 608-221-1551
P.O. BOX 7550 SE DECISION MADE: 30-JAN-02
MADISON, WI 53707-7550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINIBLASTER
DELDENT LTD. 510(k) NO: K013969(TRADITIONAL)
ATTN: ALAN EDEL PHONE NO : 723-921-1492
19 KEREN KAYEMET STREET SE DECISION MADE: 10-JAN-02
PETACH TIKVAH, ISRAEL 49372 510(k) STATEMENT
DEVICE: DELSONIC 2000
DELDENT LTD. 510(k) NO: K014238(TRADITIONAL)
ATTN: ALAN EDEL PHONE NO : 972 3 9049668
19 KEREN KAYEMET STREET SE DECISION MADE: 24-JAN-02
PETACH TIKVAH, ISRAEL 49372 510(k) STATEMENT
DEVICE: JETSONIC 2000
DELDENT LTD. 510(k) NO: K014245(TRADITIONAL)
ATTN: ALAN EDEL PHONE NO : 972 3 9049668
19 KEREN KAYEMET STREET SE DECISION MADE: 29-JAN-02
PETACH TIKVAH, ISRAEL 49372 510(k) STATEMENT
DEVICE: SLEEPBITE
DENTAL IMAGINEERS & ASSOCIATES 510(k) NO: K013808(TRADITIONAL)
ATTN: WILLIAM A BELFER PHONE NO : 732-493-4747
804 WEST PARK AVE. SE DECISION MADE: 30-JAN-02
OCEAN, NJ 07712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V AND Z-TO
DENTAL MANUFACTURING S.P.A 510(k) NO: K013824(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LANE SE DECISION MADE: 30-JAN-02
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: COOLBLU2 DENTAL RESIN CURING DEVICE
DENTAL SYSTEMS.COM, INC. 510(k) NO: K020171(SPECIAL)
ATTN: SHINOBU DOI PHONE NO : 407-927-4302
1187 TADSWORTH TERRACE SE DECISION MADE: 29-JAN-02
HEATHROW, FL 32746 510(k) STATEMENT
DEVICE: DEPUY FEMORAL HEADS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K011533(TRADITIONAL)
ATTN: LYNNETTE WHITAKER PHONE NO : 219-371-4903
700 ORTHOPAEDIC DR. SE DECISION MADE: 28-JAN-02
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER
DI-CHEM, INC. 510(k) NO: K012328(TRADITIONAL)
ATTN: KEITH A BUCHHOLZ PHONE NO : 800-847-2598
12297 ENSIGN AVE. NORTH SE DECISION MADE: 18-JAN-02
CHAMPLIN, MN 55316 510(k) STATEMENT
DEVICE: HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION
DI-CHEM, INC. 510(k) NO: K012547(TRADITIONAL)
ATTN: KEITH A BUCHHOLZ PHONE NO : 800-847-2598
12297 ENSIGN AVE. NORTH SE DECISION MADE: 18-JAN-02
CHAMPLIN, MN 55316 510(k) STATEMENT
DEVICE: ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT
DIABETES TECHNOLOGIES, INC. 510(k) NO: K013465(TRADITIONAL)
ATTN: ARTHUR G WILLIAMS PHONE NO : 229-227-1245
216 WEST JACKSON ST. SE DECISION MADE: 22-JAN-02
THOMASVILLE, GA 31792 510(k) STATEMENT
DEVICE: IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TO
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K012075(TRADITIONAL)
ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 10-JAN-02
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MO
DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K012077(TRADITIONAL)
ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200
5700 WEST 96TH ST. SE DECISION MADE: 10-JAN-02
LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN
DIAMEDIX CORP. 510(k) NO: K013956(TRADITIONAL)
ATTN: LYNNE STIRLING PHONE NO : 305-324-2300
2140 NORTH MIAMI AVE. SE DECISION MADE: 08-JAN-02
MIAMI, FL 33127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE
DIAMETRICS MEDICAL, INC. 510(k) NO: K013938(TRADITIONAL)
ATTN: NANCY RING PHONE NO : 651-638-1250
2658 PATTON RD. SE DECISION MADE: 28-JAN-02
ROSEVILLE, MN 55113 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEX ADULT HOLLOWE FIBER OXYGENATOR
DIDECO S.P.A. 510(k) NO: K014080(SPECIAL)
ATTN: BARRY S SALL PHONE NO : 781-434-4742
195 WEST STREET SE DECISION MADE: 08-JAN-02
WALTHAM, MA 02451-1163 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIOMED 15 DIODE LASER
DIOMED, LTD. 510(k) NO: K012398(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245
5 TIMBER LANE SE DECISION MADE: 22-JAN-02
NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGICFIL
DMG USA, INC. 510(k) NO: K013571(ABBREVIATED)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVENUE SE DECISION MADE: 17-JAN-02
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUXATEMP/LUXATEMP SOLAR/INSTATEMP
DMG USA, INC. 510(k) NO: K013674(TRADITIONAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVENUE SE DECISION MADE: 24-JAN-02
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRG QUICKMIX
DOCTOR'S RESEARCH GROUP, INC. 510(k) NO: K011736(TRADITIONAL)
ATTN: RICHARD DESLAURIES PHONE NO : 203-879-9422
143 WOLCOTT RD. SE DECISION MADE: 30-JAN-02
WOLCOTT, CT 06716 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOXADENT DENTAL COMPOSITE, MODELS A, B, C, 12A, 12B, 12C, 6A, 6B
DOXA CERTEX AB 510(k) NO: K011839(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5600
555 13TH STREET N.W. SE DECISION MADE: 17-JAN-02
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VAMOS ANESTHETIC GAS MONITOR
DRAEGER MEDICAL, INC. 510(k) NO: K012139(ABBREVIATED)
ATTN: JAMES J BRENNAN PHONE NO : 215-721-5400
3135 QUARRY RD. SE DECISION MADE: 17-JAN-02
TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES, MODEL: POLYSULFONE 100
DYNAMIC TECHNOLOGY CORP. 510(k) NO: K011537(TRADITIONAL)
ATTN: YAW C YANG PHONE NO : 886 357 89566
SCIENCE-BASED INDUSTRIAL PARK SE DECISION MADE: 07-JAN-02
HSINCHU, CHINA (TAIWAN) R.O.C. 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO EBI OMEGA 21 SYSTEM
EBI, L.P. 510(k) NO: K014137(SPECIAL)
ATTN: FREDERIC TESTA PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 16-JAN-02
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
EBI, L.P. 510(k) NO: K014194(SPECIAL)
ATTN: PATRICIA M FLOOD PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 17-JAN-02
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SALINE IV FLUSH SYRINGE
EMT-RX 510(k) NO: K002142(TRADITIONAL)
ATTN: ROBERT J BARD PHONE NO : 919-552-9689
9400 RANSDELL RD., SUITE 10 SE DECISION MADE: 28-JAN-02
RALEIGH, NC 27603 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASS SPINAL SYSTEM
ENCORE ORTHOPEDICS, INC. 510(k) NO: K013442(TRADITIONAL)
ATTN: JOANNA DROEGE PHONE NO : 512-832-9500
9800 METRIC BLVD. SE DECISION MADE: 15-JAN-02
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEMENTED CALCAR HIP SYSTEM
ENCORE ORTHOPEDICS, INC. 510(k) NO: K013490(TRADITIONAL)
ATTN: JOANNA DROEGE PHONE NO : 512-832-9500
9800 METRIC BLVD. SE DECISION MADE: 17-JAN-02
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYOCARE SURGICAL SYSTEM
ENDOCARE, INC. 510(k) NO: K011074(TRADITIONAL)
ATTN: VINCENT CUTARTELLI PHONE NO : 949-595-4770
7 STUDEBAKER SE DECISION MADE: 25-JAN-02
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, M
ENDOTEC, INC. 510(k) NO: K012702(TRADITIONAL)
ATTN: ALEX CANONACO PHONE NO : 973-762-0095
20 VALLEY STREET SE DECISION MADE: 30-JAN-02
SOUTH ORANGE, NJ 07079 510(k) STATEMENT
DEVICE: FINN CHAMBER (R)
EPITEST LTD. OY 510(k) NO: K013820(TRADITIONAL)
ATTN: CLAWSON BOWMAN PHONE NO : 707-793-2600
1330A REDWOOD WAY SE DECISION MADE: 30-JAN-02
PETALUMA, CA 94954-1169 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERICSCOPE, MODEL # PERISC1
ETHICON ENDO-SURGERY, INC. 510(k) NO: K013576(TRADITIONAL)
ATTN: DOUG KENTZ PHONE NO : 513-337-8699
4545 CREEK RD. SE DECISION MADE: 25-JAN-02
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DURQ/ QUALIDURA
EVER-SAFETY TECHNICAL SERVICE 510(k) NO: K013116(TRADITIONAL)
ATTN: DANIEL YANG PHONE NO :
NO 13 ALLEY 28 LANE 108 SE DECISION MADE: 18-JAN-02
YOUNG FENG RD 510(k) SUMMARY AVAILABLE FROM FDA
TAICHUNG HSIEN, TAIWAN, CHINA
DEVICE: EXEL COMFORTPOINT INSULIN PEN NEEDLE
EXELINT INTL. CO. 510(k) NO: K011757(TRADITIONAL)
ATTN: ARMAND HAMID PHONE NO : 310-649-0707
P.O. BOX 3194 SE DECISION MADE: 23-JAN-02
CULVER CITY, CA 90231-3194 510(k) STATEMENT
DEVICE: EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE
EXELINT INTL. CO. 510(k) NO: K012879(TRADITIONAL)
ATTN: ARMAND HAMID PHONE NO : 310-649-0707
5840 WEST CENTINELA AVE. SE DECISION MADE: 17-JAN-02
LOS ANGELES, CA 90045 510(k) STATEMENT
DEVICE: SEEDNET, MODEL FP6T5, FP5T5, FP5T3
GALIL MEDICAL LTD. 510(k) NO: K011950(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEEN ST.,N.W. SE DECISION MADE: 29-JAN-02
WASHINGTON, DC 20009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRISMASATE
GAMBRO RENAL PRODUCTS 510(k) NO: K013448(TRADITIONAL)
ATTN: FEI LAW PHONE NO : 386-274-2811
1845 MASON AVE. SE DECISION MADE: 15-JAN-02
DAYTONA BEACH, FL 32117-5102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BICART
GAMBRO RENAL PRODUCTS 510(k) NO: K013724(TRADITIONAL)
ATTN: FEI LAW PHONE NO : 386-274-2811
1845 MASON AVE. SE DECISION MADE: 08-JAN-02
DAYTONA BEACH, FL 32117-5102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGNA INFINITY MAGNETIC RESONANCE SYSTEM
GE MEDICAL SYSTEMS 510(k) NO: K013636(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
P.O. BOX 414 SE DECISION MADE: 24-JAN-02
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE LOGIQ 5
GE MEDICAL SYSTEMS 510(k) NO: K014097(SPECIAL)
ATTN: ALLEN SCHUH PHONE NO : 414-647-4385
P.O. 414 SE DECISION MADE: 10-JAN-02
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000)
GENERAL DEVICES 510(k) NO: K013533(TRADITIONAL)
ATTN: MICHAEL SMITH PHONE NO : 201-313-7075
1000 RIVER ST. SE DECISION MADE: 18-JAN-02
RIDGEFIELD, NJ 07657 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOGIQBOOK
GENERAL ELECTRIC CO. 510(k) NO: K014206(SPECIAL)
ATTN: ALLEN SCHUH PHONE NO : 414-647-4385
P.O. BOX 414 SE DECISION MADE: 16-JAN-02
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAC 5000 ECG ANALYSIS SYSTEM
GENERAL ELECTRIC MEDICAL SYSTEMS I510(k) NO: K014108(SPECIAL)
ATTN: DAVID WAHLIG PHONE NO : 414-362-2090
8200 WEST TOWER AVE. SE DECISION MADE: 10-JAN-02
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIMSTEP PREGNANCY
GERMAINE LABORATORIES, INC. 510(k) NO: K013857(TRADITIONAL)
ATTN: MARTIN O'CONNOER PHONE NO : 210-692-4192
4139 GARDENDALE CENTER SE DECISION MADE: 22-JAN-02
SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA
SAN ANTONIO, TX 78229
DEVICE: GLOBAL HEALTHCARE VAGINAL SPECULUM
GLOBAL HEALTHCARE 510(k) NO: K013835(TRADITIONAL)
ATTN: ALAM AHMED PHONE NO : 770-522-7520
1144 CANTON ST., SUITE 103 SE DECISION MADE: 17-JAN-02
ROSWELL, GA 30075 510(k) STATEMENT
DEVICE: WEINMANN SOMNOMASK
GOTTLIEB WEINMANN 510(k) NO: K013738(TRADITIONAL)
ATTN: ECKHARDT ALBERS PHONE NO : 011 494 0547020
KRONSAALSWEG 40 SE DECISION MADE: 22-JAN-02
HAMBURG, GERMANY 22525 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
GREAT GLOVE (THAILAND) CO. LTD. 510(k) NO: K013262(TRADITIONAL)
ATTN: KM LEE PHONE NO : 603 339 21992
180/3 M. 7 SRISONTHON RD. SE DECISION MADE: 22-JAN-02
T. SRISONTHON, 510(k) STATEMENT
A. THALANG, PHUKET, THAILAND 83110
DEVICE: ANCURE SHEATH MODEL # 40315, 40320, 40325
GUIDANT CARDIAC AND VASCULAR SURGE510(k) NO: K003889(TRADITIONAL)
ATTN: JACQUELINE J JACKSON PHONE NO : 650-470-6200
1525 O'BRIEN DR. SE DECISION MADE: 24-JAN-02
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HI-TOQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WITH HYDROCOA
GUIDANT CORP. 510(k) NO: K013833(TRADITIONAL)
ATTN: JENNIFER PAE RIGGS PHONE NO : 909-914-4581
26531 YNEZ ROAD SE DECISION MADE: 16-JAN-02
TEMECULA, CA 92592-4628 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM
GUIDANT CORP. 510(k) NO: K014007(SPECIAL)
ATTN: SABA MODJARRAD PHONE NO : 408-845-1067
3200 LAKESIDE DR. SE DECISION MADE: 07-JAN-02
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTE
GUIDANT CORP. 510(k) NO: K014184(SPECIAL)
ATTN: SABA MODJARRAD PHONE NO : 408-845-1067
3200 LAKESIDE DR. SE DECISION MADE: 18-JAN-02
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 7MM EXTENDED LENGTH ENDOSCOPE,DISSECTION TIPS, MODELS VH-1111, V
GUIDANT CORP. 510(k) NO: K014250(TRADITIONAL)
ATTN: ANNE SCHLAGENHAFT PHONE NO : 408-845-1842
3200 LAKESIDE DRIVE SE DECISION MADE: 10-JAN-02
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SU
GYNECARE, A DIV. OF ETHICON, INC. 510(k) NO: K013718(TRADITIONAL)
ATTN: GREGORY R JONES PHONE NO : 908-218-2481
P.O. BOX 151 SE DECISION MADE: 08-JAN-02
SOMERVILLE, NJ 08876-0151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECG HOME
H&C MEDICAL DEVICES SPA 510(k) NO: K012012(ABBREVIATED)
ATTN: ATTILIO CASTELLI PHONE NO : 390 222 476861
VIA PISA 250 SE DECISION MADE: 17-JAN-02
SESTO SAN GIOVANNI, ITALY 20099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM
HAEMONETICS CORP. 510(k) NO: K014083(SPECIAL)
ATTN: JOHN SOKOLOWSKI PHONE NO : 781-356-9488
400 WOOD RD. SE DECISION MADE: 08-JAN-02
P.O. BOX 9114 510(k) SUMMARY AVAILABLE FROM FDA
BRAINTREE, MA 02184
DEVICE: HL168E
HEALTH & LIFE CO., LTD. 510(k) NO: K014122(SPECIAL)
ATTN: SUSAN CHEN PHONE NO : 886 232 349600
6F,NO.407, CHUNG SHAN RD. SE DECISION MADE: 16-JAN-02
SEC.02, CHUNG HO CITY 510(k) STATEMENT
TAIPEI HSIEN, CHINA (TAIWAN) 235
DEVICE: BODYGEM, MODEL HB211
HEALTHETECH, INC. 510(k) NO: K010577(TRADITIONAL)
ATTN: NOEL L JOHNSON PHONE NO : 408-395-8210
325 LOS GATOS-SARATOGA ROAD SE DECISION MADE: 10-JAN-02
LOS GATOS, CA 95070 510(k) STATEMENT
DEVICE: ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/57
HELENA LABORATORIES 510(k) NO: K013078(TRADITIONAL)
ATTN: PATRICIA FRANKS PHONE NO : 409-842-3714
1530 LINDBERGH DR. SE DECISION MADE: 10-JAN-02
P.O. BOX 752 510(k) SUMMARY AVAILABLE FROM FDA
BEAUMONT, TX 77704
DEVICE: MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEME
HILL-ROM MANUFACTURING, , INC. 510(k) NO: K014094(SPECIAL)
ATTN: CINDY L CROSBY PHONE NO : 919-468-2300
11000 REGENCY PKWY SE DECISION MADE: 11-JAN-02
WEST TOWER, SUITE 205 510(k) SUMMARY AVAILABLE FROM FDA
CARY, NC 27511
DEVICE: INCARE INTERMITTENT CATHETER
HOLLISTER, INC. 510(k) NO: K013345(TRADITIONAL)
ATTN: JOSEPH S TOKARZ PHONE NO : 847-680-2849
2000 HOLLISTER DR. SE DECISION MADE: 07-JAN-02
LIBERTYVILLE, IL 60048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETE
HOLLISTER, INC. 510(k) NO: K013483(TRADITIONAL)
ATTN: JOSEPH TOKARZ PHONE NO : 847-680-2849
2000 HOLLISTER DR. SE DECISION MADE: 14-JAN-02
LIBERTYVILLE, IL 60048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T2 FEMORAL NAIL SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K014220(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187
59 ROUTE 17 SE DECISION MADE: 25-JAN-02
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNITRAX MODULAR UNIPOLAR SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K014226(SPECIAL)
ATTN: JENNIFER A DAUDELIN PHONE NO : 201-831-5379
59 ROUTE 17 SE DECISION MADE: 25-JAN-02
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO OPUS SPINAL SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K014229(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187
59 ROUTE 17 SE DECISION MADE: 25-JAN-02
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA), MODEL 325
HUTCHINSON TECHNOLOGY, INC. 510(k) NO: K012759(TRADITIONAL)
ATTN: JOSEPH ORTNER PHONE NO : 320-587-1926
40 WEST HIGHLAND PARK SE DECISION MADE: 17-JAN-02
HUTCHINSON, MN 55350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYDROFERA BACTERIOSTATIC WOUND DRESSING
HYDROFERA, LLC. 510(k) NO: K013462(TRADITIONAL)
ATTN: HEATHER H BOND PHONE NO : 860-456-0677
322 MAIN ST., SUITE 1101 SE DECISION MADE: 11-JAN-02
WILLIMANTIC, CT 06226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NLITE SYSTEM,MODEL A00-1025
ICN PHOTONICS LTD. 510(k) NO: K013461(TRADITIONAL)
ATTN: MIKE KIERMAN PHONE NO : 441 554 755444
UNITS 1&2 HEOL RHOSYN, SE DECISION MADE: 17-JAN-02
DAFEN PARK 510(k) SUMMARY AVAILABLE FROM FDA
LLANELLI, UNITED KINGDOM SA148QG
DEVICE: NLITE SYSTEM
ICN PHOTONICS LTD. 510(k) NO: K014130(SPECIAL)
ATTN: IAN MORTIMER PHONE NO : 441 554 755444
UNITS 1&2 HEOL RHOSYN, SE DECISION MADE: 08-JAN-02
DAFEN PARK 510(k) STATEMENT
LLANELLI, UNITED KINGDOM SA148QG
DEVICE: METAVISION CLINICAL INFORMATION SYSTEM
IMDSOFT, LTD. 510(k) NO: K012349(TRADITIONAL)
ATTN: T. WHIT ATHEY PHONE NO : 301-770-9590
12300 TWINBROOK PARKWAY, SE DECISION MADE: 29-JAN-02
SUITE 625 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20852
DEVICE: HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ
IMPLEX CORP. 510(k) NO: K010378(TRADITIONAL)
ATTN: JOHN SCHALAGO PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 28-JAN-02
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTION MAX AX-4280 URINALYSIS SYSTEM
INTERNATIONAL REMOTE IMAGING SYSTE510(k) NO: K013783(TRADITIONAL)
ATTN: CYNTHIA J.M NOLTE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 18-JAN-02
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) S
INTERPORE CROSS INTL. 510(k) NO: K014145(SPECIAL)
ATTN: LYNN M RODARTI PHONE NO : 949-453-3200
181 TECHNOLOGY DR. SE DECISION MADE: 17-JAN-02
IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTUITIVE SURGICAL ENDOWRIST ENDOSCOPIC INSTRUMENT FAMILY
INTUITIVE SURGICAL, INC. 510(k) NO: K013416(TRADITIONAL)
ATTN: MICHAEL YRAMATEGUI PHONE NO : 650-237-7048
1340 WEST MIDDLEFIELD RD. SE DECISION MADE: 10-JAN-02
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMBRYO FREEZE MEDIUM, EMBRYO THAW MEDIUM
IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K013518(TRADITIONAL)
ATTN: WENDELL LEE PHONE NO : 800-437-5706
2511 DAIMLER ST. SE DECISION MADE: 18-JAN-02
SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BCC GAMMA CAMERA
IS2 RESEARCH, INC. 510(k) NO: K013667(TRADITIONAL)
ATTN: VICTOR WOODBURN PHONE NO : 613 228 8755
20 GURDWARA RD., BAYS 3-6 SE DECISION MADE: 28-JAN-02
NEPEAN, ONTARIO, CANADA K2E 8B3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOCHRON JR. CITRATE APTT CUVETTE
ITC, INC. 510(k) NO: K014008(SPECIAL)
ATTN: JOHN CLAY PHONE NO : 800-272-1252
8 OLSEN AVENUE SE DECISION MADE: 24-JAN-02
EDISON, NJ 08820 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXCITE SELF ETCH
IVOCLAR VIVADENT, INC. 510(k) NO: K013584(TRADITIONAL)
ATTN: DONNA M HARTNETT PHONE NO : 716-691-2260
175 PINEVIEW DR. SE DECISION MADE: 28-JAN-02
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: D.SIGN 53, MODEL NA1012204
IVOCLAR VIVADENT, INC. 510(k) NO: K014082(TRADITIONAL)
ATTN: DONNA M HARTNETT PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 30-JAN-02
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: CREATINE KINASE (CK-NAC)
JAS DIAGNOSTIC, INC. 510(k) NO: K013912(TRADITIONAL)
ATTN: DAVID JOHNSTON PHONE NO : 305-418-2320
7220 NW 58TH ST. SE DECISION MADE: 18-JAN-02
MIAMI, FL 33166 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KSEA CLEARVISION LENS IRRIGATION SYSTEM
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K013838(TRADITIONAL)
ATTN: JAMES A LEE PHONE NO : 310-410-2769
600 CORPORATE POINTE SE DECISION MADE: 16-JAN-02
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KAVO POLYLUX II
KAVO AMERICA 510(k) NO: K013500(TRADITIONAL)
ATTN: JENNIFER POTTALA PHONE NO : 800-323-8029
340 EAST MAIN ST. SE DECISION MADE: 14-JAN-02
LAKE ZURICH, IL 60047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORTISOL LIA
KMI DIAGNOSTICS, INC. 510(k) NO: K010790(TRADITIONAL)
ATTN: MARK A KOWAL PHONE NO : 763-780-2955
8201 CENTRAL AVE. NE., STE. P SE DECISION MADE: 29-JAN-02
MINNEAPOLIS, MN 55432 510(k) STATEMENT
DEVICE: KONICA LASER IMAGER, DRYPRO MODEL 751/752
KONICA CORP. 510(k) NO: K013052(TRADITIONAL)
ATTN: SHINICHI YAMANAKA PHONE NO : 011 815 96373609
319 AKENO, OBATA-CHO SE DECISION MADE: 16-JAN-02
WATARAI-GUN 510(k) SUMMARY AVAILABLE FROM FDA
MIE-KEN, JAPAN 5190501
DEVICE: CLEANTEXX POWDERFREE SYNTHETIC LATEX EXAMINATION GLOVE MADE WITH
LATEXX MANUFACTURING SDN.BHD. 510(k) NO: K013303(TRADITIONAL)
ATTN: TEOH CHOH SHEE PHONE NO : 605 891 5555
PT. 5054, SE DECISION MADE: 23-JAN-02
KAMUNTING INDUSTRIAL ESTATE 510(k) SUMMARY AVAILABLE FROM FDA
TAIPING, PERAK, MALAYSIA 34600
DEVICE: LIFEGUARD NASAL CPAP MASK AND ACCESSORIES
LIFEGUARD MEDICAL PRODUCTS, INC. 510(k) NO: K013421(TRADITIONAL)
ATTN: CRAIG JOHNSON PHONE NO : 317-837-1111
120 ELM DRIVE SE DECISION MADE: 08-JAN-02
PLAINFIELD, IN 46168 510(k) STATEMENT
DEVICE: PJ.S COMFORT PORTABLE ELECTRIC BREAST PUMP
LIMERICK, INC. 510(k) NO: K012275(TRADITIONAL)
ATTN: PATRICIA KELLY PHONE NO : 818-566-3060
903 NORTH SAN FERNANDO BLVD. SE DECISION MADE: 07-JAN-02
SUITE 5 510(k) SUMMARY AVAILABLE FROM FDA
BURBANK, CA 91504
DEVICE: MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND
LOBOB LABORATORIES, INC. 510(k) NO: K014162(SPECIAL)
ATTN: DANIEL J MANELLI PHONE NO : 202-261-1000
2000 M STREET NW # 700 SE DECISION MADE: 15-JAN-02
WASHINGTON, DC 20036-3307 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUMEND PERCUTANEOUS CATHETER
LUMEND, INC. 510(k) NO: K011562(TRADITIONAL)
ATTN: MICHAEL A DANIEL PHONE NO : 415-407-0223
400 CHESAPEAKE DR. SE DECISION MADE: 16-JAN-02
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PR
MAXTER GLOVE MANUFACTURING SDN BHD510(k) NO: K013498(TRADITIONAL)
ATTN: STANLEY THAI PHONE NO : 603 615 62191
6TH MILES OFF JALAN MERU SE DECISION MADE: 17-JAN-02
KLANG SELANGOR, MALAYSIA 41050 510(k) STATEMENT
DEVICE: POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH
MAXTER GLOVE MANUFACTURING SDN BHD510(k) NO: K013554(TRADITIONAL)
ATTN: STANLEY THAI PHONE NO : 603 615 62191
6TH MILES OFF JALAN MERU SE DECISION MADE: 17-JAN-02
KLANG SELANGOR, MALAYSIA 41050 510(k) STATEMENT
DEVICE: PERCUTANEOUS INTRODUCER SET, MODEL 042294
MEDAMICUS, INC. 510(k) NO: K013120(TRADITIONAL)
ATTN: DENNIS S MADISON PHONE NO : 763-559-2613
15301 HWY. 55 WEST SE DECISION MADE: 24-JAN-02
MINNEAPOLIS, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS)
MEDI-GLOBE CORP. 510(k) NO: K010549(TRADITIONAL)
ATTN: SCOTT KARLER PHONE NO : 480-897-2772
6202 SOUTH MAPLE AVE., SE DECISION MADE: 18-JAN-02
SUITE 131 510(k) SUMMARY AVAILABLE FROM FDA
TEMPE, AZ 85283
DEVICE: PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIO
MEDICAL BIO CARE SWEDEN AB 510(k) NO: K013365(TRADITIONAL)
ATTN: CONNIE W HOY PHONE NO : 530-666-7616
908 STETSON STREET SE DECISION MADE: 08-JAN-02
WOODLAND, CA 95776 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROLITE PULSED LIGHT SYSTEM FOR THE REMOVAL OF UNWANTED HAIR
MEDICAL BIO CARE SWEDEN AB 510(k) NO: K013366(TRADITIONAL)
ATTN: CONNIE W HOY PHONE NO : 530-666-7616
908 STETSON STREET SE DECISION MADE: 08-JAN-02
WOODLAND, CA 95776 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MO
MEDICAL DATA ELECTRONICS, INC. 510(k) NO: K014294(SPECIAL)
ATTN: GREGORY ALKIRE PHONE NO : 818-768-6411
12723 WENTWORTH ST. SE DECISION MADE: 25-JAN-02
ARLETA, CA 91331 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BODYFIX
MEDICAL INTELLIGENCE MEDIZINTECHNI510(k) NO: K013391(TRADITIONAL)
ATTN: CHRISTIAN MULLER PHONE NO : 490 823 296920
FEYERABENDSTRASSE 13-15 SE DECISION MADE: 11-JAN-02
SCHWABMUNCHEN, GERMANY 86830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTABLE INTENSIVE CARE UNIT
MEDICAL RESEARCH LABORATORIES, INC510(k) NO: K012766(TRADITIONAL)
ATTN: JOEL ORLINSKY PHONE NO : 847-520-0300
1000 ASBURY DR. NO.17 SE DECISION MADE: 23-JAN-02
BUFFALO GROVE, IL 60089 510(k) STATEMENT
DEVICE: MEDITRON II THESTERTHOSCOPE SYSTEM
MEDITRON AS 510(k) NO: K013725(TRADITIONAL)
ATTN: CHARLES H KYPER PHONE NO : 919-960-0049
103 NOLEN LANE SE DECISION MADE: 30-JAN-02
CHAPEL HILL, NC 27516 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION
MEDSTONE INTL., INC. 510(k) NO: K013620(TRADITIONAL)
ATTN: RON BERGESON PHONE NO : 949-448-7700
100 COLUMBIA, SUITE 100 SE DECISION MADE: 22-JAN-02
ALISO VIEJO, CA 92656-4114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO BRIDGE SELF-EXPANDING BILIARY STENT DELIVERY SYS
MEDTRONIC AVE, INC. 510(k) NO: K014205(SPECIAL)
ATTN: KEVIN DRISCO PHONE NO : 707-541-3193
2170-A NORTHPOINT PRKWY SE DECISION MADE: 14-JAN-02
SANTA ROSA, CA 95407 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION
MEDTRONIC PERCUSURGE, INC. 510(k) NO: K014223(SPECIAL)
ATTN: MATT MOON PHONE NO : 408-530-2370
540 OAKMEAD PKWY SE DECISION MADE: 25-JAN-02
SUNNYVALE, CA 94085 510(k) STATEMENT
DEVICE: PYRAMID ANTERIOR PLATE FIXATION SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K013665(TRADITIONAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 29-JAN-02
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BUTTERFLY PLATE FIXATION SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K014267(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 25-JAN-02
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KNEE MODULE FOR THE STEALTHSTATION SYSTEM
MEDTRONIC SURGICAL NAVIGATION TECH510(k) NO: K012937(TRADITIONAL)
ATTN: VICTORIA G RENDON PHONE NO : 720-890-3200
826 COAL CREEK CIR. SE DECISION MADE: 25-JAN-02
LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STIMULUS - DISSECTION INSTRUMENTS
MEDTRONIC XOMED, INC. 510(k) NO: K014165(TRADITIONAL)
ATTN: MARTIN D SARGENT PHONE NO : 904-279-7586
6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 22-JAN-02
JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SUR
MEDTRONIC, INC. 510(k) NO: K013392(ABBREVIATED)
ATTN: SCOTT CANDY PHONE NO : 763-391-9941
7601 NORTHLAND DRIVE SE DECISION MADE: 25-JAN-02
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BREATHTEK - UBIT UBT FOR H. PYLORI
MERETEK DIAGNOSTICS, INC. 510(k) NO: K014225(SPECIAL)
ATTN: DENISE E SPELLMAN PHONE NO : 800-945-8252
618 GRASSMERE PARK DR., #20 SE DECISION MADE: 17-JAN-02
NASHVILLE, TN 37211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: YELLOW SPECIAL
METALOR TECHNOLOGIES USA 510(k) NO: K013506(TRADITIONAL)
ATTN: BRUCE BARTON PHONE NO : 800-554-5504
255 JOHN L. DIETSCH BLVD. SE DECISION MADE: 03-JAN-02
NORTH ATTLEBOROUGH, MA 02761 510(k) STATEMENT
DEVICE: V-GNATHOS SUPRA
METALOR TECHNOLOGIES USA 510(k) NO: K013769(TRADITIONAL)
ATTN: BRUCE A BARTON PHONE NO : 800-554-5504
255 JOHN L. DIETSCH BLVD. SE DECISION MADE: 22-JAN-02
NORTH ATTLEBOROUGH, MA 02761 510(k) STATEMENT
DEVICE: RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM
METRACOR TECHNOLOGIES, INC. 510(k) NO: K011238(TRADITIONAL)
ATTN: GEORGE F MCHUGH PHONE NO : 858-793-3300
11425 SORRENTO VALLEY ROAD SE DECISION MADE: 08-JAN-02
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRAORAL LENS OPTION TO SPECTROSHADE
MHT OPTIC RESEARCH AG 510(k) NO: K012744(TRADITIONAL)
ATTN: MARKUS ANGST PHONE NO : 011 41 18529000
MANDACHSTR. 50 SE DECISION MADE: 23-JAN-02
NIEDERHASLI, SWITZERLAND CH-8155 510(k) STATEMENT
DEVICE: MICROLIFE UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP-3
MICROLIFE CORP. 510(k) NO: K013485(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511
55 NORTHERN BLVD. SE DECISION MADE: 17-JAN-02
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTAB
MICROLINE, INC. 510(k) NO: K013695(TRADITIONAL)
ATTN: JACQUELINE E MASSE PHONE NO : 781-239-8108
70 WALNUT STREET SE DECISION MADE: 08-JAN-02
WELLESLEY, MA 02481 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: POCKETVIEW ECG SOFTWARE
MICROMEDICAL INDUSTRIES, LTD. 510(k) NO: K013311(SPECIAL)
ATTN: STEPHEN CRESSWELL PHONE NO : 617 557 39777
11 TECHNOLOGY DR. SE DECISION MADE: 03-JAN-02
LABRADOR, QUEENSLAND, AUSTRALIA 42510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPS320 CARDIAC STIMULATOR
MICROPACE PTY. LTD. 510(k) NO: K011826(TRADITIONAL)
ATTN: MICHAEL CEJNAR PHONE NO : 612 978 76166
571 CANTERBURY RD. SE DECISION MADE: 24-JAN-02
CAMPSIE, N.S.W., AUSTRALIA 2194 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M COMPLY 1248 GAS PLASMA CHEMICAL INDICATOR
MINNESOTA MINING AND MFG. CO. 510(k) NO: K013228(TRADITIONAL)
ATTN: TIERNEY NORSTED PHONE NO : 952-946-8080
5353 WAYZATA BLVD. SE DECISION MADE: 18-JAN-02
SUITE 505 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55416
DEVICE: MISONIX IRRIGATION SYSTEM MOEDL BC20P
MISONIX, INC. 510(k) NO: K013417(TRADITIONAL)
ATTN: ALBERT F CLANCY PHONE NO : 516-694-9555
1938 NEW HIGHWAY SE DECISION MADE: 10-JAN-02
FARMINGDALE, NY 11735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123
MORAX 510(k) NO: K012789(SPECIAL)
ATTN: BOREK JANIK PHONE NO : 734-475-2441
13805 WATERLOO ROAD SE DECISION MADE: 17-JAN-02
CHELSEA, MI 48118 510(k) STATEMENT
DEVICE: COMPAS AS (COMPUTERIZED PULMONARY ANALYSIS SYSTEM)
MORGAN SCIENTIFIC, INC. 510(k) NO: K013752(TRADITIONAL)
ATTN: PATRICK MORGAN PHONE NO : 978-521-4440
151 ESSEX ST. SE DECISION MADE: 30-JAN-02
HAVERHILL, MA 01832 510(k) STATEMENT
DEVICE: PHSL-63 PEDIATRIC HEAD AND SPINE ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K013514(TRADITIONAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SUITE A SE DECISION MADE: 02-JAN-02
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: UNIGLOVE LANO-E POWDER-FREE LATEX EXAMINATION GLOVES
N.S. UNI-GLOVES SDN. BHD. 510(k) NO: K013163(TRADITIONAL)
ATTN: ROBERT D VANDER LEEK PHONE NO : 310-328-7981
UG HEALTHCARE (USA) INC SE DECISION MADE: 22-JAN-02
2420 CARSON ST. SUITE 125 510(k) SUMMARY AVAILABLE FROM FDA
TORRANCE, CA 90501
DEVICE: WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860
NELLCOR PURITAN BENNETT, INC. 510(k) NO: K014121(SPECIAL)
ATTN: ANTHONY MULLIN PHONE NO : 314-654-3049
4280 HACIENDA DR. SE DECISION MADE: 11-JAN-02
PLEASANTON, CA 94588-2719 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEOLEAD
NEOTECH PRODUCTS, INC. 510(k) NO: K011564(TRADITIONAL)
ATTN: ARNOLD M HEYMAN PHONE NO : 818-700-2600
9135-F ALABAMA AVE. SE DECISION MADE: 03-JAN-02
CHATSWORTH, CA 91311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION OF NC-STAT
NEUROMETRIX, INC. 510(k) NO: K013459(TRADITIONAL)
ATTN: SHIELA HEMEON-HEYER PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 17-JAN-02
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL7500 MICROCURRENT TENS DEVICE, MCT-F5, MCT-F50, MCT-F500
NEWCARE PRODUCTS LLC. 510(k) NO: K013167(TRADITIONAL)
ATTN: T. WHIT ATHEY PHONE NO : 301-770-9590
12300 TWINBROOK PKWY. SE DECISION MADE: 30-JAN-02
SUITE 625 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20852
DEVICE: NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (
NONIN MEDICAL, INC. 510(k) NO: K013319(TRADITIONAL)
ATTN: RICHARD P BENNETT PHONE NO : 763-577-3166
2605 FERNBROOK LANE, NORTH SE DECISION MADE: 03-JAN-02
MINNEAPOLIS, MN 55447-4755 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STAT PROFILE PHOX BASIC ANALYZER
NOVA BIOMEDICAL CORP. 510(k) NO: K013729(TRADITIONAL)
ATTN: PAUL W MACDONALD PHONE NO : 781-894-0800
200 PROSPECT ST. SE DECISION MADE: 15-JAN-02
WALTHAM, MA 02454-9141 510(k) STATEMENT
DEVICE: NUMED MULLINS PTA CATHETER
NUMED, INC. 510(k) NO: K013601(SPECIAL)
ATTN: NICHELLE R LAFLESH PHONE NO : 315-328-4491
2880 MAIN STREET SE DECISION MADE: 03-JAN-02
HOPKINTON, NY 12965 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUMED COEFFICIENT PTV CATHETERS
NUMED, INC. 510(k) NO: K014124(SPECIAL)
ATTN: NICHELLE R LAFLASH PHONE NO : 315-328-4491
2880 MAIN ST. SE DECISION MADE: 16-JAN-02
HOPKINTON, NY 12965 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LTF-240 PLEURAVIDEOSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMEN
OLYMPUS OPTICAL CO., LTD. 510(k) NO: K013617(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
TWO CORPORATE CENTER DRIVE SE DECISION MADE: 30-JAN-02
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM
ON SITE GAS SYSTEMS, INC. 510(k) NO: K014078(TRADITIONAL)
ATTN: C. BARTON GULLONG PHONE NO : 860-229-2799
100 PRODUCTION COURT SE DECISION MADE: 08-JAN-02
NEW BRITAIN, CT 06051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND
OPUSDENT LTD. 510(k) NO: K014100(SPECIAL)
ATTN: ARAVA HACOHEN PHONE NO : 972 977 18130
117 AHUZAH ST. SE DECISION MADE: 08-JAN-02
RA'ANANNA, ISRAEL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUCLEOTOMY INTRADISCAL CATHETER
ORATEC INTERVENTIONS, INC. 510(k) NO: K013622(TRADITIONAL)
ATTN: LINDA GUTHRIE PHONE NO : 650-369-9904
3700 HAVEN CT. SE DECISION MADE: 31-JAN-02
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KPS-I, THE KIDNEY PERFUSION SOLUTION
ORGAN RECOVERY SYSTEMS, INC. 510(k) NO: K013575(TRADITIONAL)
ATTN: STANLEY J HARRIS PHONE NO : 843-722-6756
701 EAST BAY STREET SE DECISION MADE: 25-JAN-02
SUITE 433 510(k) SUMMARY AVAILABLE FROM FDA
CHARLESTON, SC 29403
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2,
ORTHO-CLINICAL DIAGNOSTICS 510(k) NO: K013899(TRADITIONAL)
ATTN: MARLENE A SHULMAN PHONE NO : 716-453-4041
100 INDIGO CREEK DR. SE DECISION MADE: 24-JAN-02
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTAEON PROBE
OSTEOBIOLOGICS, INC. 510(k) NO: K013429(TRADITIONAL)
ATTN: MARK Q NIEDERAUER PHONE NO : 210-690-2131
UNIVERSITY BUSINESS PARK SE DECISION MADE: 11-JAN-02
12500 NETWORK, SUITE 112 510(k) SUMMARY AVAILABLE FROM FDA
SAN ANTONIO, TX 78249-3308
DEVICE: OSTEOMED BIORESORBABLE FIXATION SYSTEM
OSTEOMED CORP. 510(k) NO: K012486(TRADITIONAL)
ATTN: DAWN T HOLDEMAN PHONE NO : 972-241-3401
3750 REALTY RD. SE DECISION MADE: 16-JAN-02
ADDISON, TX 75001-4311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PADPRO MODEL 2001, 2001-S, 2001-C, 2001-EPS
PADPRO LLC. 510(k) NO: K014209(SPECIAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O.BOX 7007 SE DECISION MADE: 18-JAN-02
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEKOMPRESSOR PERCUTANEOUS LUMBAR DISCECTOMY PROBE
PAIN CONCEPTS, INC. 510(k) NO: K013513(TRADITIONAL)
ATTN: RUSSELL PFLUEGER PHONE NO : 949-754-3035
8001 IRVINE CENTER DRIVE SE DECISION MADE: 17-JAN-02
4TH FLOOR 510(k) STATEMENT
IRVINE, CA 92618
DEVICE: MODIFICATION TO OUTBACK CATHETER
PERCLOSE, INC. 510(k) NO: K014117(SPECIAL)
ATTN: SEVRINA CIUCCI PHONE NO : 650-474-3164
400 SAGINAW SE DECISION MADE: 11-JAN-02
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SUPERCROSS CATHETER
PERCLOSE, INC. 510(k) NO: K014118(SPECIAL)
ATTN: SEVRINA CIUCCI PHONE NO : 650-474-3164
400 SAGINAW SE DECISION MADE: 11-JAN-02
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTI-SNARE SET
PFM PRODUKTE FUR DIE MEDIZIN AG 510(k) NO: K011783(TRADITIONAL)
ATTN: SALVADORE F PALOMARES PHONE NO : 949-463-6146
15 CHEROKEE STREET SE DECISION MADE: 24-JAN-02
TRABUCO CANYON, CA 92679 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE, MODELS M3860A, M3861A,
PHILIPS MEDICAL SYSTEMS 510(k) NO: K013425(TRADITIONAL)
ATTN: TAMARA YOUNT PHONE NO : 206-664-5141
2401 FOURTH AVE., SUITE 500 SE DECISION MADE: 14-JAN-02
SEATTLE, WA 98121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861,
PHILIPS MEDICAL SYSTEMS 510(k) NO: K014157(SPECIAL)
ATTN: TAMARA YOUNT PHONE NO : 206-664-5000
2401 FOURTH AVE., SUITE 500 SE DECISION MADE: 17-JAN-02
SEATTLE, WA 98121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540
PHILIPS MEDICAL SYSTEMS 510(k) NO: K014191(TRADITIONAL)
ATTN: STEVE SINGLAR PHONE NO : 978-659-2101
3000 MINUTEMAN RD. SE DECISION MADE: 07-JAN-02
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K013894(TRADITIONAL)
ATTN: LYNN HARMER PHONE NO : 425-487-7312
22100 BOTHELL EVERETT HWY SE DECISION MADE: 18-JAN-02
P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98041-3003
DEVICE: INFINION 0.6T MR IMAGING SYSTEM
PHILIPS MEDICAL SYSTEMS(CLEVELAND)510(k) NO: K013858(TRADITIONAL)
ATTN: DUANE C PRASCHAN PHONE NO : 440-483-5743
595 MINER RD. SE DECISION MADE: 22-JAN-02
HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILLIPS M1175A/76A/77A COMPONENT MONITORING SYSTEM; PHILLIPS V2
PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K014159(SPECIAL)
ATTN: DAVE OSBORN PHONE NO : 978-659-3173
3000 MINUTEMAN RD. SE DECISION MADE: 18-JAN-02
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M2376A DEVICELINK SYSTEM, MODEL M2376A
PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K014181(SPECIAL)
ATTN: MIKE HUDON PHONE NO : 978-659-3173
3000 MINUTEMAN RD. MS 0491 SE DECISION MADE: 15-JAN-02
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLANMED SOPHIE & PLANMED SOPHIE CLASSIC
PLANMED OY 510(k) NO: K013656(TRADITIONAL)
ATTN: BOB PIENKOWSKI PHONE NO : 630-953-2368
1250 GREENBRIAR, SUITE A SE DECISION MADE: 16-JAN-02
ADDISON, IL 60101 510(k) STATEMENT
DEVICE: PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP
PORGES S.A. 510(k) NO: K013174(ABBREVIATED)
ATTN: BERNARD ISMAEL PHONE NO : 335 533 13131
USINE DU PONTET BP 89 SE DECISION MADE: 04-JAN-02
SARLAT, FRANCE 24203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NYCOCARD CRP CONTROL
PRIMUS CORP. 510(k) NO: K014084(TRADITIONAL)
ATTN: JIM NOFFSINGER PHONE NO : 816-523-7491
SE DECISION MADE: 07-JAN-02
510(k) STATEMENT
DEVICE: PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY
PSYCHEMEDICS CORP. 510(k) NO: K011185(TRADITIONAL)
ATTN: WILLIAM R TISTLE PHONE NO : 617-868-7455
5832 UPLANDER WAY SE DECISION MADE: 24-JAN-02
CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNAPULSE 5200A PATHWAY BLOOD PRESSURE MONITORING SYSTEM
PULSE METRIC, INC. 510(k) NO: K013478(SPECIAL)
ATTN: ROBERT DUFFY PHONE NO : 858-480-1171
11777 SORRENTO VALLEY ROAD SE DECISION MADE: 10-JAN-02
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ
QUANTECH LTD. 510(k) NO: K012943(TRADITIONAL)
ATTN: ROBIN J HELLEN PHONE NO : 818-709-5646
9418 LASAINE AVE SE DECISION MADE: 18-JAN-02
NORTHRIDGE, CA 91325 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R&D RET-LINE KIT
R & D SYSTEMS, INC. 510(k) NO: K013898(TRADITIONAL)
ATTN: RALPH E HOGANCAMP PHONE NO : 612-379-2956
614 MCKINLEY PL., N.E. SE DECISION MADE: 22-JAN-02
MINNEAPOLIS, MN 55413 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RANDOX CARBAMAZEPINE
RANDOX LABORATORIES, LTD. 510(k) NO: K011648(TRADITIONAL)
ATTN: PAULINE ARMSTRONG PHONE NO : 441 849 422413
55 DIAMOND RD. SE DECISION MADE: 15-JAN-02
CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) STATEMENT
DEVICE: RANDOX VALPROIC ACID
RANDOX LABORATORIES, LTD. 510(k) NO: K011649(TRADITIONAL)
ATTN: PAULINE ARMSTRONG PHONE NO : 441 849 422413
55 DIAMOND RD. SE DECISION MADE: 15-JAN-02
CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) STATEMENT
DEVICE: RANDOX THEOPHYLLINE
RANDOX LABORATORIES, LTD. 510(k) NO: K011771(TRADITIONAL)
ATTN: P ARMSTRONG PHONE NO : 440 289 4422413
55 DIAMOND RD. SE DECISION MADE: 17-JAN-02
CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) STATEMENT
DEVICE: RANDOX DIGITOXIN
RANDOX LABORATORIES, LTD. 510(k) NO: K012112(TRADITIONAL)
ATTN: PAULINE ARMSTRONG PHONE NO : 440 289 4422413
55 DIAMOND RD. SE DECISION MADE: 11-JAN-02
CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) STATEMENT
DEVICE: RAVEN BACTERIAL SPORE STRIPS
RAVEN BIOLOGICAL LABORATORIES, INC510(k) NO: K020026(SPECIAL)
ATTN: WENDY ROYALTY-HANN PHONE NO : 402-593-0781
8607 PARK DR. SE DECISION MADE: 30-JAN-02
OMAHA, NE 68127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTMONITOR 2, MODEL 4000
RESPIRONICS GEORGIA, INC. 510(k) NO: K011597(ABBREVIATED)
ATTN: BETSY CORTELLONI PHONE NO : 770-429-1212
175 CHASTAIN MEADOWS COURT SE DECISION MADE: 11-JAN-02
KENNESAW, GA 30144-3724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REMSTAR AUTO CPAP SYSTEM
RESPIRONICS, INC. 510(k) NO: K012554(SPECIAL)
ATTN: DAVID J VANELLA PHONE NO : 724-733-5866
1001 MURRY RIDGE LANE SE DECISION MADE: 29-JAN-02
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RHODIA BITE REGISTRATION MATERIAL
RHODIA INC. 510(k) NO: K013859(TRADITIONAL)
ATTN: ALAIN MORIN PHONE NO : 805-653-5638
320 W. STANLEY AVE SE DECISION MADE: 29-JAN-02
VENTURA, CA 93001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RIBBOND - TRIAXIAL
RIBBOND, INC. 510(k) NO: K013881(TRADITIONAL)
ATTN: SHOSHANA RUDO DRIVER PHONE NO : 206-340-8870
1402 3RD AVE., SUITE 1030 SE DECISION MADE: 25-JAN-02
SEATTLE, WA 98101-2118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: WINNER ST-2 STIMULATOR
RICH-MAR CORP. 510(k) NO: K013770(SPECIAL)
ATTN: DAVID RICHARDS PHONE NO : 918-543-2222
15499 EAST 590TH RD. SE DECISION MADE: 18-JAN-02
P.O. BOX 879 510(k) STATEMENT
INOLA, OK 74036
DEVICE: MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTI
RICH-MAR CORP. 510(k) NO: K013771(SPECIAL)
ATTN: DAVID RICHARDS PHONE NO : 918-543-2222
15499 EAST 590TH RD. SE DECISION MADE: 18-JAN-02
P.O. BOX 879 510(k) STATEMENT
INOLA, OK 74036
DEVICE: LIGHT PROJECTOR WITH ENDOSCOPIC CAMERA, 1 CCD CAMERA HEAD NTSC,
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K010033(TRADITIONAL)
ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY. SE DECISION MADE: 10-JAN-02
VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOTECH POWERED WHEELCHAIR, C650PW
ROC CHINESE-EUROPEAN INDUSTRIAL RE510(k) NO: K011846(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO.58, FU-CHIUN STREET, SE DECISION MADE: 18-JAN-02
HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: ROCHE ACETAMINOPHEN
ROCHE DIAGNOSTICS CORP. 510(k) NO: K013757(TRADITIONAL)
ATTN: MIKE FLIS PHONE NO : 800-428-5074
9115 HAGUE RD. SE DECISION MADE: 08-JAN-02
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROSSMAX MEDIPRO, MODELS 100F, 200F, AND 300F BLOOD PRESSURE MONI
ROSSMAX INTERNATIONAL LTD. 510(k) NO: K013539(ABBREVIATED)
ATTN: MICHAEL YEH PHONE NO : 011 886 226597888
12F., NO.189, KANG CHIEN RD. SE DECISION MADE: 17-JAN-02
TAIPEI, CHINA (TAIWAN) 114 510(k) STATEMENT
DEVICE: ROSSMAX MEDIPRO MODEL 10 AND 60, MEDICARE MODEL 10 AND 60 BLOOD
ROSSMAX INTERNATIONAL LTD. 510(k) NO: K013583(ABBREVIATED)
ATTN: MICHAEL YEH PHONE NO : 011 886 226597888
12F., NO.189, KANG CHIEN RD. SE DECISION MADE: 17-JAN-02
TAIPEI, CHINA (TAIWAN) 114 510(k) STATEMENT
DEVICE: ANTERIOR CERVICAL PLATE SYSTEM
SCIENT'X 510(k) NO: K013439(TRADITIONAL)
ATTN: JOANNA DROEGE PHONE NO : 512-832-9500
9800 METRIC BLVD. SE DECISION MADE: 14-JAN-02
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISOBAR SPINAL SYSTEM
SCIENT'X 510(k) NO: K013447(TRADITIONAL)
ATTN: JOANNA DREOGE PHONE NO : 512-832-9500
9800 METRIC BLVD. SE DECISION MADE: 15-JAN-02
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCI-PHARM POST SECURE
SCIENTIFIC PHARMACEUTICALS, INC. 510(k) NO: K013555(TRADITIONAL)
ATTN: JAN A ORLOWSKI PHONE NO : 909-595-9922
3221 PRODUCER WAY SE DECISION MADE: 23-JAN-02
POMONA, CA 91768 510(k) STATEMENT
DEVICE: PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS
SCOTT E ALLEN CP 510(k) NO: K012804(TRADITIONAL)
ATTN: SCOTT E ALLEN PHONE NO : 801-364-3100
50 SOUTH 900 EAST #1 SE DECISION MADE: 17-JAN-02
SALT LAKE CITY, UT 84102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-STERILE POWDERED LATEX EXAMINATION GLOVES WITH A PROTEIN CLA
SEAL POLYMER INDUSTRIES SDN. BHD. 510(k) NO: K014055(TRADITIONAL)
ATTN: CHUN C FONG PHONE NO : 605 322 3200
LT 72706, JALAN LAHAT, KAWASAN SE DECISION MADE: 28-JAN-02
PERINDUSTRIAN BUKIT MERAH 510(k) SUMMARY AVAILABLE FROM FDA
LAHAT, IPOH, PERAK, MALAYSIA 31500
DEVICE: SEMPERMED SUPREME, SIZES 5.5, 6, 6.5, 7, 7.5, 8, 8.5, AND 9
SEMPERIT TECHNISCHE PRODUKTE GESEL510(k) NO: K013560(ABBREVIATED)
ATTN: JAY MANSOUR PHONE NO : 678-908-8180
1308 MORNINGSTAR PARK DR SE DECISION MADE: 16-JAN-02
APHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSOR
SENORX, INC. 510(k) NO: K013641(TRADITIONAL)
ATTN: AMY BOUCLY PHONE NO : 949-362-4800
11 COLUMBIA, SUITE A SE DECISION MADE: 29-JAN-02
ALISO VIEJO, CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDIPORT 2000 MOBILE
SERVOX MEDIZINTECHNIK GMBH 510(k) NO: K013585(TRADITIONAL)
ATTN: MARTIN HERBERG PHONE NO : 022 189 9000
69 SERVATIUSSTRASSE SE DECISION MADE: 28-JAN-02
POSTAL CODE 51109 510(k) STATEMENT
KOLN, GERMANY 51109
DEVICE: SHARGHP A.V. FISTULA NEEDLE SET
SHARGH PHARMACEUTICAL CO., INC. 510(k) NO: K013384(TRADITIONAL)
ATTN: ARMAND HAMEDANI PHONE NO : 310-649-0707
5840 WEST CENTINELA AVE. SE DECISION MADE: 07-JAN-02
BUILDING 2 510(k) STATEMENT
LOS ANGELES, CA 90045
DEVICE: POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA @PH 5.5 AND
SHEN WEI (USA), INC. 510(k) NO: K013793(TRADITIONAL)
ATTN: BELLE L CHOU PHONE NO : 510-429-8692
2845 WHIPPLE RD. SE DECISION MADE: 22-JAN-02
UNION CITY, CA 94587 510(k) STATEMENT
DEVICE: POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM
SHEN WEI (USA), INC. 510(k) NO: K013794(TRADITIONAL)
ATTN: BELLE L CHOU PHONE NO : 510-429-8692
2845 WHIPPLE RD. SE DECISION MADE: 22-JAN-02
UNION CITY, CA 94587 510(k) STATEMENT
DEVICE: POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM
SHEN WEI (USA), INC. 510(k) NO: K013795(TRADITIONAL)
ATTN: BELLE L CHOU PHONE NO : 510-429-8692
2845 WHIPPLE RD. SE DECISION MADE: 22-JAN-02
UNION CITY, CA 94587 510(k) STATEMENT
DEVICE: CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013
SHIRE BIOLOGICS INC. 510(k) NO: K013523(TRADITIONAL)
ATTN: ANGELA ROGERS PHONE NO : 508-351-1006
WORLDWIDE REGULATORY AFFAIRS SE DECISION MADE: 07-JAN-02
10182 TELESIS COURT 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92121
DEVICE: MINI SHOPPER
SHOPRIDER INTL., INC. 510(k) NO: K013927(TRADITIONAL)
ATTN: CHRIS TINSLEY PHONE NO : 620-325-2629
P.O. BOX 187 SE DECISION MADE: 28-JAN-02
NEODESHA, KS 66757 510(k) STATEMENT
DEVICE: KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E
SIEMENS ELEMA AB 510(k) NO: K010923(ABBREVIATED)
ATTN: DIANE WURZBURGER PHONE NO : 732-321-4765
MEDICAL SOLUTIONS SE DECISION MADE: 23-JAN-02
186 WOOD AVENUE SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
ISELIN, NJ 08830-2770
DEVICE: INFINITY EXPLORER
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K013515(TRADITIONAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 10-JAN-02
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIEMENS INFINITY GATEWAY SUITE
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K014213(SPECIAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 17-JAN-02
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SABRE COMPAC
SLE LIMITED 510(k) NO: K011842(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 858-587-1147
PO BOX 12038 SE DECISION MADE: 08-JAN-02
LA JOLLA, CA 92039-2038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW OPERATIVE HYSTEROSCOPE, MODEL 7209208; SMITH & NE
SMITH & NEPHEW, INC. 510(k) NO: K013870(TRADITIONAL)
ATTN: JANICE HASELTON PHONE NO : 978-749-1000
160 DASCOMB RD. SE DECISION MADE: 17-JAN-02
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SORBA STEORRA NON-INVASIVE IMPEDANCE CARDIOGRAPH
SORBA MEDICAL SYSTEMS, INC. 510(k) NO: K014299(SPECIAL)
ATTN: JILL BARNEY PHONE NO : 262-827-2740
165 BISHOPS WAY, SUITE 152 SE DECISION MADE: 30-JAN-02
BROOKFIELD, WI 53005 510(k) STATEMENT
DEVICE: ASCEND SPINAL FIXATION SYSTEM WITH THE SHADOW SPINAL SYSTEM
SPINAL INNOVATIONS, LLC. 510(k) NO: K013196(TRADITIONAL)
ATTN: KENNETH RUSSELL PHONE NO : 901-373-8855
7850 STAGE HILLS BLVD. SE DECISION MADE: 30-JAN-02
SUITE 105 510(k) SUMMARY AVAILABLE FROM FDA
BARTLETT, TN 38133
DEVICE: SAFE
SSN MEDICAL PRODUCTS SDN. BHD. 510(k) NO: K013773(ABBREVIATED)
ATTN: ANG TECK LEONG PHONE NO : 6 03 77812829
NO. 1, JALAN 203, OFF JALAN SE DECISION MADE: 24-JAN-02
TANDANG 510(k) STATEMENT
PETALING JAYA, SELANGOR, MALAYSIA 46050
DEVICE: SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE)
ST. JUDE MEDICAL, INC. 510(k) NO: K014037(SPECIAL)
ATTN: WILLIAM MCKELVEY PHONE NO : 651-415-7029
ONE LILLEHEI PLAZA SE DECISION MADE: 04-JAN-02
ST. PAUL, MN 55117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE)
ST. JUDE MEDICAL, INC. 510(k) NO: K014161(SPECIAL)
ATTN: WILLIAM MCKELVEY PHONE NO : 651-415-7029
ONE LILLEHEI PLAZA SE DECISION MADE: 15-JAN-02
ST. PAUL, MN 55117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO SPA INTELLIGENT
STARBENE 510(k) NO: K992099(TRADITIONAL)
ATTN: JUDITH NIZTZSCHMAMN PHONE NO : 543 513 4240051
DAVID LUQUE 519 SE DECISION MADE: 18-JAN-02
CORDOBA, PVCIA. CORDOBA, ARGENTINA510(k) STATEMENT
DEVICE: EPOCA CODR STEM AND HEAD
STELKAST CO. 510(k) NO: K014049(SPECIAL)
ATTN: DONALD A STEVENS PHONE NO : 412-322-8280
800 VINIAL ST. #210 SE DECISION MADE: 09-JAN-02
PITTSBURGH, PA 15212 510(k) STATEMENT
DEVICE: NOTTA AMBULATORY RECORDER
STELLATE SYSTEMS 510(k) NO: K013450(ABBREVIATED)
ATTN: GEORGE PAPAGIANNIS PHONE NO : 514 486 1306
345 VICTORIA AVE., SUITE 300 SE DECISION MADE: 14-JAN-02
WESTMOUNT, QUEBEC, CANADA H3Z 2N2 510(k) STATEMENT
DEVICE: REPROCESSED ELECTROSURGICAL ELECTRODE
STERILMED, INC. 510(k) NO: K012684(TRADITIONAL)
ATTN: PATRICK FLEISCHHACKER PHONE NO : 888-856-4870
11400 73RD AVE. NORTH SE DECISION MADE: 18-JAN-02
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMPLICITY STARPLUS SOFT INFUSION SET
STERLING MEDIVATIONS, INC. 510(k) NO: K014061(ABBREVIATED)
ATTN: JOEL S DOUGLAS PHONE NO : 650-949-0470
25285 LA LOMA DR. SE DECISION MADE: 17-JAN-02
LOS ALTOS HILLS, CA 94022-4583 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMPLICITY EASY ACCESS INFUSION SET
STERLING MEDIVATIONS, INC. 510(k) NO: K014062(ABBREVIATED)
ATTN: JOEL S DOUGLAS PHONE NO : 650-949-0470
25285 LA LOMA DR. SE DECISION MADE: 17-JAN-02
LOS ALTOS HILLS, CA 94022-4583 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM
STRYKER LEIBINGER 510(k) NO: K013775(SPECIAL)
ATTN: ROBIN L ROWE PHONE NO : 877-534-2464
4100 EAST MILHAM AVE SE DECISION MADE: 08-JAN-02
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3.75MM AND 5.0MM SPLINE TWIST IMPLANT
SULZER DENTAL, INC. 510(k) NO: K013494(TRADITIONAL)
ATTN: FOSTER BOOP PHONE NO : 760-929-4300
1900 ASTON AVE. SE DECISION MADE: 18-JAN-02
CARLSBAD, CA 92008-7308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPO
SULZER INTRATHERAPEUTICS, INC. 510(k) NO: K014136(SPECIAL)
ATTN: MARIA E BRITTLE PHONE NO : 651-697-9797
651 CAMPUS DR. SE DECISION MADE: 17-JAN-02
ST. PAUL, MN 55112-3495 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G)
SUPERGRADE HEALTHCARE PRODUCTS SDN510(k) NO: K014134(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 22-JAN-02
SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH AL
SUPERMAX GLOVE MANUFACTURING SDN B510(k) NO: K013589(TRADITIONAL)
ATTN: STANLEY THAI PHONE NO : 603 615 72328
LOT 42, PUTRA INDUSTRIAL PARK SE DECISION MADE: 08-JAN-02
BUKIT RAHMAN PUTRA 510(k) STATEMENT
SUNGAI BULOH, SELANGOR, MALAYSIA 47000
DEVICE: SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETIC SUT
SURGICAL SPECIALTIES CORP. 510(k) NO: K014021(TRADITIONAL)
ATTN: ELIZABETH LAZARO PHONE NO : 610-404-1000
100 DENNIS DRIVE SE DECISION MADE: 28-JAN-02
READING, PA 19606-3776 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSO
SURX, INC. 510(k) NO: K011190(TRADITIONAL)
ATTN: ALAN CURTIS PHONE NO : 925-417-1400
6900 KOLL CENTER PKWY., #417 SE DECISION MADE: 08-JAN-02
PLEASANTON, CA 94566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SWIFT LOW PROFILE CUP (PRO CUP)
SWIFT DELIVERY PRODUCTS 510(k) NO: K013460(TRADITIONAL)
ATTN: RICHARD G LINDSAY PHONE NO : 405-721-8227
6824 ELK CANYON RD. SE DECISION MADE: 17-JAN-02
OKLAHOMA CITY, OK 73162 510(k) STATEMENT
DEVICE: POINT 4 MODIFIED
SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K013510(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 18-JAN-02
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POINT 4 TRANSLUCENT MODIFIED
SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K013529(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 09-JAN-02
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXUS 2 CLEAR
SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K013609(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 16-JAN-02
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVOLUTION FORMULA 2
SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K013647(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 16-JAN-02
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIKED WASHER
SYNTHES (USA) 510(k) NO: K011583(TRADITIONAL)
ATTN: THOMAS M MAGUIRE PHONE NO : 610-647-9700
1690 RUSSELL ROAD SE DECISION MADE: 30-JAN-02
POST OFFICE BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301
DEVICE: SYNTHES ANKLE ARTHRODESIS PLATE
SYNTHES (USA) 510(k) NO: K013415(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 11-JAN-02
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PUMP TUBING
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K013578(TRADITIONAL)
ATTN: GARRY A COURTNEY PHONE NO : 800-283-7866
125 BLUE BALL ROAD SE DECISION MADE: 22-JAN-02
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TETRAD MODEL TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP TRANSDUCE
TETRAD CORP. 510(k) NO: K014182(TRADITIONAL)
ATTN: CHARLES F HOTTINGER PHONE NO : 408-741-1006
357 INVERNESS DR. SOUTH, SE DECISION MADE: 03-JAN-02
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
ENGLEWOOD, CO 80112 THIRD PARTY REVIEW
DEVICE: THERMAGE THERMACOOL TC SYSTEM
THERMAGE, INC. 510(k) NO: K013639(TRADITIONAL)
ATTN: PAMELA M BUCKMAN PHONE NO : 510-259-7116
4058 POINT EDEN WAY SE DECISION MADE: 29-JAN-02
HAYWARD, CA 94545-3721 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERMACOL
TISSUE SCIENCE LABORATORIES, PLC 510(k) NO: K013625(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5600
555 THIRTEENTH ST. N.W. SE DECISION MADE: 17-JAN-02
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HI-ART SYSTEM
TOMO THERAPY INC 510(k) NO: K013673(TRADITIONAL)
ATTN: KENNETH D BUROKER PHONE NO : 608-824-0995
2228 EVERGREEN ROAD SE DECISION MADE: 28-JAN-02
MIDDLETON, WI 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPTIAM SYPHILIS-G ASSAY
TRINITY BIOTECH, PLC 510(k) NO: K014233(SPECIAL)
ATTN: FIONA CAMPBELL PHONE NO : 011 353 12769800
IDA BUSINESS PARK BRAY SE DECISION MADE: 24-JAN-02
CO. WICKLOW, IRELAND 510(k) STATEMENT
DEVICE: ERCHONIA PL2000
TUCO INNOVATIONS, INC. 510(k) NO: K012580(TRADITIONAL)
ATTN: KEVIN WALL PHONE NO : 720-962-5412
13 RED FOX LANE SE DECISION MADE: 17-JAN-02
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: L-25 ABSORBABLE SURIGCAL SUTURE
UNITED STATES SURGICAL, A DIVISION510(k) NO: K013671(ABBREVIATED)
ATTN: ROBERT ZOTT PHONE NO : 203-845-4515
150 GLOVER AVE. SE DECISION MADE: 08-JAN-02
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXTREMITY COIL
USA INSTRUMENTS, INC. 510(k) NO: K013592(TRADITIONAL)
ATTN: RONY THOMAS PHONE NO : 330-562-1000
1515 DANNER DRIVE SE DECISION MADE: 08-JAN-02
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BODY ARRAY COIL
USA INSTRUMENTS, INC. 510(k) NO: K013594(TRADITIONAL)
ATTN: RONY THOMAS PHONE NO : 330-562-1000
1515 DANNER DRIVE SE DECISION MADE: 22-JAN-02
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PREMIER III PHASED ARRAY CTL SPINE COIL
USA INSTRUMENTS, INC. 510(k) NO: K013595(TRADITIONAL)
ATTN: RONY THOMAS PHONE NO : 330-562-1000
1515 DANNER DRIVE SE DECISION MADE: 22-JAN-02
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANGUARD REPROCESSED INFLATION DEVICES
VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K012480(TRADITIONAL)
ATTN: MIKE SAMMON PHONE NO : 863-683-8680
5307 GREAT OAK DR. SE DECISION MADE: 22-JAN-02
LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASCULAR SOLUTIONS DUETT FLOWABLE HEMOSTAT
VASCULAR SOLUTIONS, INC. 510(k) NO: K012293(TRADITIONAL)
ATTN: DEBORAH L JENSEN PHONE NO : 763-656-4349
2495 XENIUM LANE NORTH SE DECISION MADE: 18-JAN-02
MINNEAPOLIS, MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASOCOR VASCULAR DIAGNOSTIC CENTER (MODEL 300)
VASOCOR, INC. 510(k) NO: K011625(TRADITIONAL)
ATTN: WALTER M ROSEBROUGH PHONE NO : 305-592-7260
499 A JESSEN LANE SE DECISION MADE: 23-JAN-02
CHARLESTON, NC 29492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOCO LITE, MODEL TD-01
VENTREX, INC. 510(k) NO: K013477(TRADITIONAL)
ATTN: ROBERT GUTHRIE PHONE NO : 805-658-2984
3007 BUNSEN AVE., UNIT L & K SE DECISION MADE: 17-JAN-02
VENTURA, CA 93003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECISION PLUS TUNA OFFICE SYSTEM
VIDAMED, INC. 510(k) NO: K014224(SPECIAL)
ATTN: YI CHEN PHONE NO : 510-492-4900
46107 LANDING PKWY. SE DECISION MADE: 23-JAN-02
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM
VON ZEPPELIN GMBH 510(k) NO: K013091(TRADITIONAL)
ATTN: DIETER VON ZEPPELIN PHONE NO : 498 979 36880
GISTLSTRASSE 99 SE DECISION MADE: 25-JAN-02
PULLACH, GERMANY D-82049 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VOXAR'S CALCIUM SCORING PRODUCT
VOXAR LIMITED 510(k) NO: K020140(TRADITIONAL)
ATTN: CONRAD CMIN PHONE NO : 440 131 4723792
BONNINGTON BOND, 2 ANDERSON PL SE DECISION MADE: 28-JAN-02
EDINBURGH, UNITED KINGDOM EH6 5NP 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: NUTRISAFE PUR ENTERAL FEEDING TUBE
VYGON CORP. 510(k) NO: K003311(TRADITIONAL)
ATTN: ROBERT SCHIFF PHONE NO : 973-227-1830
1129 BLOOMFIELD AVE. SE DECISION MADE: 11-JAN-02
WEST CALDWELL, NJ 07006 510(k) STATEMENT
DEVICE: VIABAHN ENDOPROSTHESIS
W.L. GORE & ASSOCIATES,INC 510(k) NO: K013648(TRADITIONAL)
ATTN: TIMOTHY J RYNN PHONE NO : 928-864-3714
3750 WEST KILTIE LN. SE DECISION MADE: 08-JAN-02
FLAGSTAFF, AZ 86002-0900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SELF-DRILLING RADIOGRAPHIC MARKER
WALTER LORENZ SURGICAL, INC. 510(k) NO: K014148(SPECIAL)
ATTN: KIM REED PHONE NO : 904-741-4400
1520 TRADEPORT DR. SE DECISION MADE: 17-JAN-02
JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIENER LAB. ALP 405
WIENER LABORATORIES S.A.I.C. 510(k) NO: K013983(TRADITIONAL)
ATTN: VIVIANA CETOLA PHONE NO : 54 341 4329191
2944 RIOBAMBA SE DECISION MADE: 28-JAN-02
ROSARIO, ARGENTINA 2000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTE
WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K020019(TRADITIONAL)
ATTN: YUE W CHOW PHONE NO : 011 603 87061486
LOT 1, JALAN 3, SE DECISION MADE: 23-JAN-02
KAWASAN PERUSAHAAN BANDAR BARU 510(k) SUMMARY AVAILABLE FROM FDA
SALAK TINGGI, SEPANG SELANGOR, MALAYSIA 43900
DEVICE: 84 CHANNEL EEG
XLTEK 510(k) NO: K014146(SPECIAL)
ATTN: SONJA MARKEZ PHONE NO : 905 829 5300
2568 BRISTOL CIRCLE SE DECISION MADE: 14-JAN-02
OAKVILLE, CANADA L6H 5S1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 80 CHANNEL EEG
XLTEK 510(k) NO: K014147(SPECIAL)
ATTN: SONJA MARKEZ PHONE NO : 905 829 5300
2568 BRISTOL CIRCLE SE DECISION MADE: 14-JAN-02
OAKVILLE, CANADA L6H 5S1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE
ZIMMER, INC. 510(k) NO: K013385(TRADITIONAL)
ATTN: STEPHEN MCKELVEY PHONE NO : 219-372-4944
P.O. BOX 708 SE DECISION MADE: 09-JAN-02
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 304
TOTAL WITH SUMMARIES 232
TOTAL WITH STATEMENTS 72
Updated 11/25/02
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