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510(k)s Final Decisions Rendered for September 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-SEP-2002 THROUGH 30-SEP-2002
DEVICE: CALSCOR SOFTWARE
3D MED CO., LTD. 510(k) NO: K021913(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 06-SEP-02
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS
3T MEDICAL SYSTEMS, LLC. 510(k) NO: K022287(TRADITIONAL)
ATTN: ROBERT P EATON PHONE NO : 303-838-2407
12553 S. WAMBLEE VALLEY ROAD SE DECISION MADE: 23-SEP-02
CONIFER, CO 80433-6204 510(k) STATEMENT
DEVICE: PICCOLO PHOSPHORUS TEST SYSTEM
ABAXIS, INC. 510(k) NO: K022312(TRADITIONAL)
ATTN: ROBERT MILDER PHONE NO : 510-675-6524
3240 WHIPPLE RD. SE DECISION MADE: 05-SEP-02
UNION CITY, CA 94587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIRECT BILIRUBIN
ABBOTT LABORATORIES 510(k) NO: K022180(TRADITIONAL)
ATTN: MICHELE SMITH-WAHEED PHONE NO : 972-518-7466
1920 HURD DRIVE SE DECISION MADE: 06-SEP-02
IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDISENSE PRECISION EASYBLOOD GLUCOSE MONITORING SYSTEM, MEDISEN
ABBOTT LABORATORIES 510(k) NO: K022182(TRADITIONAL)
ATTN: JANET CONNOLLY PHONE NO : 781-276-6230
4-A CROSBY DR. SE DECISION MADE: 09-SEP-02
BEDFORD, MA 01730-1402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOTAL BILIRUBIN
ABBOTT LABORATORIES 510(k) NO: K022339(TRADITIONAL)
ATTN: MICHELE SMITH-WAHEED PHONE NO : 972-518-7466
1920 HURD DRIVE SE DECISION MADE: 13-SEP-02
IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGE
ABBOTT LABORATORIES INC 510(k) NO: K023062(SPECIAL)
ATTN: FRANK POKROP PHONE NO : 847-937-8473
200 ABBOTT PARK RD SE DECISION MADE: 30-SEP-02
DEPT 0389 BLDG J-45 510(k) SUMMARY AVAILABLE FROM FDA
ABBOTT PARK, IL 60064-6133
DEVICE: IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,I
AGFA CORP. 510(k) NO: K022292(TRADITIONAL)
ATTN: DAVID LEDWIG PHONE NO : 201-373-3680
PO BOX 1927 SE DECISION MADE: 12-SEP-02
BREVARD, NC 28712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LR DICOM CONTROLLER
AGFA CORP. 510(k) NO: K022658(SPECIAL)
ATTN: JEFF JEDLICKA PHONE NO : 864-421-1806
10 SOUTH ACADEMY ST. SE DECISION MADE: 06-SEP-02
GREENVILLE, SC 29601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSE
AGFA CORP. 510(k) NO: K023020(TRADITIONAL)
ATTN: PAMELA K GWYNN PHONE NO : 919-549-1697
10 SOUTH ACADEMY ST. SE DECISION MADE: 26-SEP-02
GREENVILLE, SC 29601 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE
ALARIS MEDICAL SYSTEMS, INC. 510(k) NO: K022677(SPECIAL)
ATTN: RENEE L FLUET PHONE NO : 858-458-7563
10221 WATERIDGE CIR. SE DECISION MADE: 11-SEP-02
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES
AR ALLIANCE HEALTHCARE SDN. BHD. 510(k) NO: K022619(TRADITIONAL)
ATTN: CHUA CHOON CHUAN PHONE NO : 600 459 37616
8, LORONG IND. 11, KAWASAN SE DECISION MADE: 06-SEP-02
PERINDUSTRIAN BUKIT PANCHOR, 510(k) STATEMENT
NIBONG TEBAL, PULAU PINANG, MALAYSIA 14300
DEVICE: PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P.
ARC MEDICAL SUPPLIES (BEIJING) CO,510(k) NO: K022664(TRADITIONAL)
ATTN: CHARLES F ANDREWS PHONE NO : 414-416-9119
1591 S. MOORLAND ROAD SE DECISION MADE: 10-SEP-02
SUITE 104 510(k) SUMMARY AVAILABLE FROM FDA
NEW BERLIN, WI 53151
DEVICE: POCKETCHEM UA AUTION STICKS 10TA
ARKRAY, INC. 510(k) NO: K022386(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808
163 CABOT STREET SE DECISION MADE: 17-SEP-02
BEVERLY, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX UNIVERS FRACTURE PROSTHESIS
ARTHREX, INC. 510(k) NO: K020345(TRADITIONAL)
ATTN: VERNON BROWN PHONE NO : 941-643-5553
2885 SOUTH HORSESHOE DR. SE DECISION MADE: 06-SEP-02
NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LASERSYSTEM BEAUTYSTAR 532
ASCLEPION-MEDITEC AG 510(k) NO: K021975(TRADITIONAL)
ATTN: WILLIAM KELLY PHONE NO :
8884 WARNER AVENUE SE DECISION MADE: 13-SEP-02
SUITE 167 510(k) SUMMARY AVAILABLE FROM FDA
FOUNTIAN VALLEY, CA 92708
DEVICE: AXIAMED TRANS-SACRAL SPINAL ACCESS DEVICE
AXIAMED, INC. 510(k) NO: K020457(TRADITIONAL)
ATTN: W ALLEN PUTNAM PHONE NO : 952-474-7351
5200 WILSON ROAD SE DECISION MADE: 26-SEP-02
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
EDINA, MN 55424
DEVICE: AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL S
AXYA MEDICAL, INC. 510(k) NO: K021929(TRADITIONAL)
ATTN: HOWARD L SCHRAYER PHONE NO : 609-924-9510
100 CUMMINGS CENTER SE DECISION MADE: 10-SEP-02
SUITE 444C 510(k) SUMMARY AVAILABLE FROM FDA
BEVERLY, MA 01915
DEVICE: CEREC VITABLOCKS MK2
B.B.'S PROPHY SHOP 510(k) NO: K022408(TRADITIONAL)
ATTN: HORST MICHAEL BIRKHOFF PHONE NO : 49 218 172246
GRUNSTR.2 SE DECISION MADE: 06-SEP-02
GREVENBROICH, GERMANY D-41516 510(k) STATEMENT
DEVICE: POST AND CORE - THIN FOR THE BASIC DENTAL IMPLANT SYSTEM
BASIC DENTAL IMPLANT SYSTEMS, INC.510(k) NO: K022912(SPECIAL)
ATTN: DAN BLACKLOCK PHONE NO : 505-881-1376
3321 COLUMBIA, N.E. SE DECISION MADE: 20-SEP-02
ALBUQUERQUE, NM 87107-2001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD
BAYER DIAGNOSTICS CORP. 510(k) NO: K022331(SPECIAL)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE SE DECISION MADE: 11-SEP-02
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA TESTPOINT CSF CONTROL
BAYER DIAGNOSTICS CORP. 510(k) NO: K022968(TRADITIONAL)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE SE DECISION MADE: 24-SEP-02
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTE
BECKMAN COULTER, INC. 510(k) NO: K021814(TRADITIONAL)
ATTN: BRENT TABER PHONE NO : 952-368-1323
1000 LAKE HAZELTINE DR. SE DECISION MADE: 27-SEP-02
CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET
BECTON DICKINSON & CO. 510(k) NO: K022875(SPECIAL)
ATTN: M. WENDY BOSSHARDT PHONE NO : 201-847-6280
1 BECTON DRIVE SE DECISION MADE: 11-SEP-02
FRANKLIN LAKES, NJ 07417-1880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BREAST BOLSTER
BEEKLEY CORP. 510(k) NO: K020624(TRADITIONAL)
ATTN: MAEGHAN E ARCHAMBAULT PHONE NO : 800-233-5539
PRESTIGE LANE SE DECISION MADE: 12-SEP-02
BRISTOL, CT 06010 510(k) STATEMENT
DEVICE: BENJAMIN ENVOY PHACO HANDPIECE
BENJAMIN BIOMEDICAL, INC. 510(k) NO: K022833(TRADITIONAL)
ATTN: ARTHUR WARD PHONE NO : 813-645-2855
962 ALLEGRO LANE SE DECISION MADE: 09-SEP-02
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CRANIAL SYMMETRY SYSTEM
BEVERLY HILLS PROSTHETICS ORTHOTIC510(k) NO: K022273(TRADITIONAL)
ATTN: KEITH E VINNECOUR PHONE NO : 323-866-2555
6300 WILSHIRE BLVD., SUITE 150 SE DECISION MADE: 09-SEP-02
LOS ANGELES, CA 90048-5203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SP
BINAX, INC. 510(k) NO: K021646(TRADITIONAL)
ATTN: ANNE JEPSON PHONE NO : 207-772-3988
217 READ ST. SE DECISION MADE: 19-SEP-02
PORTLAND, ME 04103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SP
BINAX, INC. 510(k) NO: K021649(TRADITIONAL)
ATTN: ANNE JEPSON PHONE NO : 207-772-3988
217 READ ST. SE DECISION MADE: 19-SEP-02
PORTLAND, ME 04103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPEC
BINAX, INC. 510(k) NO: K021687(TRADITIONAL)
ATTN: ANNE JEPSON PHONE NO : 207-772-3988
217 READ ST. SE DECISION MADE: 13-SEP-02
PORTLAND, ME 04103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EYEFEEL OPHTHALMIC WARMER
BIO-LIPID, INC. 510(k) NO: K021843(TRADITIONAL)
ATTN: DAVID J BLOCH PHONE NO : 202-414-9209
1301 K STREET, N.W. SE DECISION MADE: 03-SEP-02
SUITE 1100 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20005
DEVICE: BIO-RAD PLATELIA TOXO IGM TMB
BIO-RAD 510(k) NO: K013837(TRADITIONAL)
ATTN: CHRISTOPHER BENTSEN PHONE NO : 425-881-8300
6565 185TH AVENUE NE SE DECISION MADE: 30-SEP-02
REDMOND, WA 98052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO-RAD PLATELIA TOXO IGG TMB
BIO-RAD 510(k) NO: K013839(TRADITIONAL)
ATTN: CHRISTOPHER BENTSEN PHONE NO : 425-881-8300
6565 185TH AVENUE NE SE DECISION MADE: 30-SEP-02
REDMOND, WA 98052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 591,
BIO-RAD 510(k) NO: K022991(TRADITIONAL)
ATTN: MARIA ZEBALLOS PHONE NO : 949-598-1367
9500 JERONIMO ROAD SE DECISION MADE: 17-SEP-02
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-4
BIOMEDICAL LIFE SYSTEMS, INC. 510(k) NO: K020712(TRADITIONAL)
ATTN: RICHARD SAXON PHONE NO : 760-727-5600
2448 CADES WAY SE DECISION MADE: 24-SEP-02
VISTA, CA 92083 510(k) STATEMENT
DEVICE: BIOMET CALCANEAL PLATE
BIOMET ORTHOPEDICS, , INC. 510(k) NO: K022515(TRADITIONAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639
P.O. BOX 587 SE DECISION MADE: 17-SEP-02
WARSAW, IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALCIUM PHOSPHATE GRANULAR BONE VOID FILLER
BIOMET, INC. 510(k) NO: K011531(TRADITIONAL)
ATTN: DALENE T BINKLEY PHONE NO : 219-267-1612
SE DECISION MADE: 06-SEP-02
510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHORT AND LONG SOFT TISSUE ATTACHMENT
BIOMET, INC. 510(k) NO: K022079(TRADITIONAL)
ATTN: KACY ARNOLD PHONE NO : 574-372-1644
P.O. BOX 587 SE DECISION MADE: 24-SEP-02
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXATION
BIOPLATE, INC. 510(k) NO: K022890(SPECIAL)
ATTN: CAROL E JONES PHONE NO : 323-549-9500
6911 MELROSE AVE. SE DECISION MADE: 06-SEP-02
LOS ANGELES, CA 90038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES
BIOPSY SCIENCES, LLC 510(k) NO: K021847(TRADITIONAL)
ATTN: SHARON ROCKWELL PHONE NO : 714-695-9269
5582 CHALON ROAD SE DECISION MADE: 03-SEP-02
YORBA LINDA, CA 92886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIRST CHOICE & FIRST CHOICE PLUS
BODY CLOCK HEALTH CARE LTD 510(k) NO: K022076(TRADITIONAL)
ATTN: JONATHAN BASH PHONE NO : 020 853 29595
108 GEORGE LANE SE DECISION MADE: 24-SEP-02
SOUTH WOODFORD, LONDON, UNITED KIN510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONVOY ADVANCED DELIVERY SHEATH
BOSTON SCIENTIFIC 510(k) NO: K022067(TRADITIONAL)
ATTN: ANDREA L RUTH PHONE NO : 408-895-3625
2710 ORCHARD PARKWAY SE DECISION MADE: 11-SEP-02
SAN JOSE, CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: URETERAL ACCESS SHEATH SET (UASS)
BOSTON SCIENTIFIC CORP. 510(k) NO: K022135(ABBREVIATED)
ATTN: JANET A MCGRATH PHONE NO : 508-650-8726
ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 13-SEP-02
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER
BOSTON SCIENTIFIC CORP. 510(k) NO: K022621(SPECIAL)
ATTN: HEIDI M ERICKSON PHONE NO : 763-494-2564
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 04-SEP-02
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521
BOSTON SCIENTIFIC CORP. 510(k) NO: K022648(SPECIAL)
ATTN: PAIGE SWEENEY PHONE NO : 508-652-5560
ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 05-SEP-02
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS
BRAHMS DIAGNOSTICA, LLC. 510(k) NO: K021057(TRADITIONAL)
ATTN: WILLIAM G FRANK PHONE NO : 770-449-7738
35 B SOUTH PEACHTREE STREET SE DECISION MADE: 17-SEP-02
NORCROSS, GA 30071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPLAN
BRAINLAB AG 510(k) NO: K020631(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 498 999 15680
AMMERTHALSTRASSE 8 SE DECISION MADE: 09-SEP-02
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRIGHTWAY BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (
BRIGHTWAY HOLDINGS SDN. BHD. 510(k) NO: K022878(TRADITIONAL)
ATTN: G. BASKARAN PHONE NO : 603 334 31007
LOT 1559, JALAN ISTIMEWA SE DECISION MADE: 17-SEP-02
BATU BELAH, KLANG 510(k) STATEMENT
SELANGOR DARUL EHSAN, MALAYSIA 42100
DEVICE: TDP HEAT LAMP OR INFRARED HEATING LAMP, MODELS CQG-S1, CQG-111A/
C&H; INTERNATIONAL 510(k) NO: K020851(TRADITIONAL)
ATTN: YUANHUI LUO PHONE NO : 281-352-1880
1202 MELFORD DRIVE SE DECISION MADE: 23-SEP-02
HOUSTON, TX 77077 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COA
C.R. BARD, INC. 510(k) NO: K002612(ABBREVIATED)
ATTN: GEORGIA C ABERNATHY PHONE NO : 770-784-6454
8195 INDUSTRIAL BLVD. SE DECISION MADE: 03-SEP-02
COVINGTON, GA 30209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARDPORT X-PORT ISP PORT
C.R. BARD, INC. 510(k) NO: K022983(SPECIAL)
ATTN: JOHN C KNORPP PHONE NO : 801-595-0700
5425 WEST AMELIA EARHART DR. SE DECISION MADE: 25-SEP-02
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE POWDER FREE VINYL EXAM GLOVES, WITH VITAMIN E
CANOPUS MEDICAL SUPPLY CO., LTD. 510(k) NO: K022368(TRADITIONAL)
ATTN: RUBY LIN PHONE NO : 011 886 227162107
10TH FL.,NO. 201 SE DECISION MADE: 05-SEP-02
FU HSING NORTH ROAD 510(k) STATEMENT
TAIPEI, CHINA (TAIWAN) 105
DEVICE: MODIFICATION TO CARDEON ASCENDING BALLOON CANNULA (ABC)
CARDEON CORP. 510(k) NO: K022042(TRADITIONAL)
ATTN: JANE BEGGS PHONE NO : 408-517-2522
10161 BUBB RD. SE DECISION MADE: 03-SEP-02
CUPERTINO, CA 95014-4133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLOBAL ECG MANAGEMENT SYSTEM (GEMS)
CARDIOCOMM SOLUTIONS, INC. 510(k) NO: K022297(SPECIAL)
ATTN: ANGELA HALWAS PHONE NO : 250 744 1822
3060 CEDAR HILL ROAD SE DECISION MADE: 27-SEP-02
SUITE 201 510(k) SUMMARY AVAILABLE FROM FDA
VICTORIA, B.C., CANADA V8T 3J5
DEVICE: CLASSIC NMS
CARE REHAB, INC. 510(k) NO: K021905(TRADITIONAL)
ATTN: CHRISTIAN E HUNT PHONE NO : 703-448-9644
1124 DOMINION COURT SE DECISION MADE: 05-SEP-02
MCLEAN, VA 22102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CELL ROBOTICS ULTRA-LIGHT PEEL LASER SYSTEM
CELL ROBOTICS, INC. 510(k) NO: K021946(TRADITIONAL)
ATTN: GLEN GOFF PHONE NO : 505-343-1131
2715 BROADBENT PKWY., N.E. SE DECISION MADE: 11-SEP-02
ALBUQUERQUE, NM 87107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRINICA SELECT ANTERIOR CERVICAL PLATE SYSTEM
CENTERPULSE SPINE-TECH, INC. 510(k) NO: K022344(SPECIAL)
ATTN: TIM MILLER PHONE NO : 952-830-6284
7375 BUSH LAKE ROAD SE DECISION MADE: 24-SEP-02
MINNEAPOLIS, MN 55439-3037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHLORAPREP
CENTRIX, INC. 510(k) NO: K021131(TRADITIONAL)
ATTN: JOHN DISCKO PHONE NO : 203-929-5582
770 RIVER ROAD SE DECISION MADE: 26-SEP-02
SHELTON, CT 06484-5458 510(k) STATEMENT
DEVICE: CHASE CARDIOVASCULAR PATCH KIT
CHASE MEDICAL, INC. 510(k) NO: K022093(TRADITIONAL)
ATTN: DAVE HERNON PHONE NO : 972-783-0644
1876 FIRMAN DR. SE DECISION MADE: 20-SEP-02
RICHARDSON, TX 75081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)
CHROMAVISION MEDICAL SYSTEMS, INC.510(k) NO: K012138(TRADITIONAL)
ATTN: DAVID DAVIS PHONE NO : 949-443-3355
33171 PASEO CERVEZA SE DECISION MADE: 30-SEP-02
SAN JUAN CAPESTRANO, CA 92675 510(k) STATEMENT
DEVICE: CLARUS STRAIGHT FIRING LASER FIBER; CLARUS SIDE FIRING LASER FIB
CLARUS MEDICAL, LLC. 510(k) NO: K021848(TRADITIONAL)
ATTN: TOM BARTHEL PHONE NO : 763-525-8403
1000 BOONE AVE. NORTH SE DECISION MADE: 03-SEP-02
MINNEAPOLIS, MN 55427 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR THE DADE BN I
CLINIQA CORPORATION 510(k) NO: K022758(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900
1432 SOUTH MISSION ROAD SE DECISION MADE: 17-SEP-02
FALLBROOK, CA 92028 510(k) STATEMENT
DEVICE: PRESS-MATE PM-2100 VITAL SIGN MONITOR
COLIN MEDICAL INSTRUMENTS CORP. 510(k) NO: K022537(TRADITIONAL)
ATTN: MARK RISON PHONE NO : 800-829-6427
5850 FARINON DR. SE DECISION MADE: 13-SEP-02
SAN ANTONIO, TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM
COLTENE AG 510(k) NO: K022224(TRADITIONAL)
ATTN: H.J. VOGELSTEIN PHONE NO : 201-512-8000
750 CORPORATE DRIVE SE DECISION MADE: 18-SEP-02
MAHWAH, NJ 07430 510(k) STATEMENT
DEVICE: ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM AND ACCESSORIES
COMPUTER MOTION, INC. 510(k) NO: K021152(TRADITIONAL)
ATTN: DAVID MUNJAL PHONE NO : 805-685-3729
130-B CREMONA DRIVE SE DECISION MADE: 24-SEP-02
SANTA BARBARA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR D
CONTAMAC LTD. 510(k) NO: K021977(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LANE SE DECISION MADE: 12-SEP-02
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: COOK-SWARTZ DOPPLER FLOW PROBE
COOK VASCULAR, INC. 510(k) NO: K022649(SPECIAL)
ATTN: THOMAS J KARDOS PHONE NO : 724-845-8621
RT. 66, RIVER RD. SE DECISION MADE: 06-SEP-02
P.O. BOX 529 510(k) SUMMARY AVAILABLE FROM FDA
LEECHBURG, PA 15656
DEVICE: ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
COOK, INC. 510(k) NO: K022552(SPECIAL)
ATTN: KAREN BRADBURN PHONE NO : 812-339-2235
750 DANIELS WAY SE DECISION MADE: 27-SEP-02
P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA
BLOOMINGTON, IN 47402-0489
DEVICE: REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 02
CORGENIX, INC. 510(k) NO: K022990(SPECIAL)
ATTN: NANCI DEXTER PHONE NO : 303-457-4345
12061 TEJON ST. SE DECISION MADE: 25-SEP-02
WESTMINSTER, CO 80234 510(k) STATEMENT
DEVICE: REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODE
CORGENIX, INC. 510(k) NO: K022992(SPECIAL)
ATTN: NANCI DEXTER PHONE NO : 303-457-4345
12061 TEJON ST. SE DECISION MADE: 25-SEP-02
WESTMINSTER, CO 80234 510(k) STATEMENT
DEVICE: DISPOSABLE TEMPORARY PACING CABLE,MODELS CPW-BV-5,CPW-LG-5,CPW-S
CP MEDICAL 510(k) NO: K022075(TRADITIONAL)
ATTN: MARY ANN GREENAWALT PHONE NO : 503-232-1555
836 N.E. 24TH AVE. SE DECISION MADE: 19-SEP-02
PORTLAND, OR 97232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRAFTMATIC ADJUSTABLE BEDS WITH OPTIONAL HEAT & MASSAGE, MODELS
CRAFTMATIC ORGANIZATION, INC. 510(k) NO: K022387(TRADITIONAL)
ATTN: PAUL D RUBIN PHONE NO : 202-457-5646
2550 M STREET, N.W. SE DECISION MADE: 19-SEP-02
WASHINGTON, DC 20037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CVSI PERIPHERAL BALLOON CATHETER; CVSI INFLATER
CRYO VASCULAR SYSTEMS INC. 510(k) NO: K022061(TRADITIONAL)
ATTN: R. MICHAEL CROMPTON PHONE NO : 408-376-3675
160 KNOWLES DRIVE SE DECISION MADE: 20-SEP-02
LOS GATOS, CA 95032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMAPAL, UVA 50HZ, UVA 60HZ, UVB BROAD BAND 50HZ, UVB BROAD BAN
DAAVLIN DISTRIBUTING CO. 510(k) NO: K022104(TRADITIONAL)
ATTN: CHAD REYNOLDS PHONE NO : 419-636-6304
205 WEST BEMENT ST. SE DECISION MADE: 10-SEP-02
BRYAN, OH 43506 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERCON CERAM S PORCELAIN
DENTSPLY INTL. 510(k) NO: K022796(SPECIAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVE SE DECISION MADE: 06-SEP-02
YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIDECO ELECTA
DIDECO S.P.A. 510(k) NO: K020647(ABBREVIATED)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 05-SEP-02
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11
DIGIBIO TECHNOLOGY CORP. 510(k) NO: K014141(TRADITIONAL)
ATTN: ERIC LUO PHONE NO : 972-491-2059
6833 SAINT LAWRENCE STREET SE DECISION MADE: 13-SEP-02
PLANO, TX 75024 510(k) STATEMENT
DEVICE: MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP
DISETRONIC MEDICAL SYSTEMS AG 510(k) NO: K022831(SPECIAL)
ATTN: SANDRA SONIEC PHONE NO : 413 442 42884
KIRCHBERSTRASSE 190, POSTFACH SE DECISION MADE: 11-SEP-02
BURGDORF, SWEDEN CH-3401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOTAL KNEE CEMENTED, SEMI-CONSTRAINED
DJ ORTHOPEDICS, LLC. 510(k) NO: K021740(TRADITIONAL)
ATTN: NORA C.R. YORK PHONE NO : 760-734-3122
2985 SCOTT ST. SE DECISION MADE: 23-SEP-02
VISTA, CA 92083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOCXS B SERIES ELECTRODES
DOCXS, LLC 510(k) NO: K020903(TRADITIONAL)
ATTN: RICHARD RIZZOLO PHONE NO : 707-462-2351
564 SOUTH DORA, SUITE A-1 SE DECISION MADE: 26-SEP-02
UKIAH, CA 95482 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE QUASAR NUCLEAR MEDICINE SYSTEM
ELGEMS, LTD. 510(k) NO: K022960(TRADITIONAL)
ATTN: HEMY NEUMAN PHONE NO :
10 HAYOZMA ST. SE DECISION MADE: 19-SEP-02
TIRAT HACARMEL, ISRAEL 30200 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: IMPERIUM
ELMSTECH, INC. 510(k) NO: K022114(TRADITIONAL)
ATTN: TIM MANGERUGA PHONE NO : 516-942-3900
950 JERICHO TURNPIKE SE DECISION MADE: 17-SEP-02
WESTBURY, NY 11590 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100; AORTIC CANNUL
EMBOL-X, INC. 510(k) NO: K020693(TRADITIONAL)
ATTN: EDWIN LEE PHONE NO : 650-390-0280
645 CLYDE AVE. SE DECISION MADE: 05-SEP-02
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLASH 1
EMED, INC. 510(k) NO: K022583(TRADITIONAL)
ATTN: KENNETH KARASIUK PHONE NO : 805-446-2200
191 WEST WILBUR ROAD SE DECISION MADE: 17-SEP-02
SUITE 103 510(k) STATEMENT
THOUSAND OAKS, CA 91360
DEVICE: INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000
EQUIDYNE SYSTEMS, INC. 510(k) NO: K022502(TRADITIONAL)
ATTN: JIM BARELY PHONE NO : 858-753-1163
11770 BERNARDO PLAZA CT. SE DECISION MADE: 05-SEP-02
SUITE 351 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92128
DEVICE: PORTABLE THERAPEUTIC OXYGEN CONCENTRATION SYSTEM (PTOCS)
ESSEX CRYOGENICS OF MISSOURI, INC.510(k) NO: K022684(ABBREVIATED)
ATTN: ELIZABETH HUNNICUT PHONE NO : 314-832-8077
8007 CHIVVIS DR. SE DECISION MADE: 11-SEP-02
ST. LOUIS, MO 63123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018
ETHICON ENDO-SURGERY, INC. 510(k) NO: K021266(TRADITIONAL)
ATTN: KEN CHARAK PHONE NO : 513-337-7987
4545 CREEK RD. SE DECISION MADE: 27-SEP-02
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COATED VICRYL* (POLYGLACTIN 910) SUTURE
ETHICON, INC. 510(k) NO: K022269(TRADITIONAL)
ATTN: LEA ANN CONWAY PHONE NO : 908-218-2478
ROUTE 22 WEST SE DECISION MADE: 13-SEP-02
SOMERVILLE, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XLTEK SLEEP SYSTEM
EXCEL TECH. LTD. 510(k) NO: K022037(SPECIAL)
ATTN: SONJA MARKEZ PHONE NO : 905 829 5300
2568 BRISTOL CIRCLE SE DECISION MADE: 10-SEP-02
OAKVILLE, ONTARIO, CANADA L6H 5S1510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXEL SECURETOUCH SAFETY VACULET BLOOD COLLECTION SET
EXELINT INTL. CO. 510(k) NO: K022406(TRADITIONAL)
ATTN: ARMAND HAMID PHONE NO : 310-649-0707
5840 WEST CENTINELA AVE. SE DECISION MADE: 30-SEP-02
LOS ANGELES, CA 90045 510(k) STATEMENT
DEVICE: LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D
FISCHER INDUSTRIES, INC. 510(k) NO: K022154(TRADITIONAL)
ATTN: PHIL O'KEEFE PHONE NO : 630-232-2803
2630 KANEVILLE COURT SE DECISION MADE: 30-SEP-02
GENEVA, IL 60134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TWIN FIX
FIXANO SA 510(k) NO: K022771(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 858-587-1147
P.O BOX 12038 SE DECISION MADE: 23-SEP-02
LA JOLLA, CA 92039-2038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSFER COMPANION HR 3000 MANUAL WHEELCHAIR
FOREVER YOUNG ENT. CO., LTD. 510(k) NO: K022699(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO. 58 FU-CHIUN ST. SE DECISION MADE: 13-SEP-02
HSIN-CHU CITY,, CHINA 300 510(k) STATEMENT
DEVICE: DELUXE MANUAL WHEELCHAIR HW 4000
FOREVER YOUNG ENT. CO., LTD. 510(k) NO: K022700(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO. 58 FU-CHIUN ST. SE DECISION MADE: 13-SEP-02
HSIN-CHU CITY,, CHINA 300 510(k) STATEMENT
DEVICE: 8 CHANNEL CARDIAC PHASED ARRAY COIL
GE MEDICAL SYSTEMS 510(k) NO: K022669(SPECIAL)
ATTN: LARRY KROGER PHONE NO : 262-544-3894
P.O. BOX 414 SE DECISION MADE: 06-SEP-02
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMART BREATH RESPIRATORY COMPENSATION OPTION
GE MEDICAL SYSTEMS 510(k) NO: K022919(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
P.O. 414 SE DECISION MADE: 19-SEP-02
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: OEC FLUOROTRAK 9800 PLUS
GE OEC MEDICAL SYSTEMS 510(k) NO: K022069(TRADITIONAL)
ATTN: BILL GISLASON PHONE NO : 800-874-7378
384 WRIGHT BROTHERS DR. SE DECISION MADE: 17-SEP-02
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEN-PROBE APTIMA COMBO 2 ASSAY
GEN-PROBE, INC. 510(k) NO: K022874(TRADITIONAL)
ATTN: ALAN MADERAZO PHONE NO : 858-410-8332
10210 GENETIC CENTER DR. SE DECISION MADE: 17-SEP-02
SAN DIEGO, CA 92121 510(k) STATEMENT
DEVICE: GE ROAD WARRIOR PET CT IMAGING SYSTEM
GENERAL ELECTRIC CO. 510(k) NO: K022872(SPECIAL)
ATTN: DAVID DUERSTELER PHONE NO : 262-312-7029
P.O. BOX 414 SE DECISION MADE: 12-SEP-02
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013
GOOD BIOTECH CORP. 510(k) NO: K022725(TRADITIONAL)
ATTN: VICTOR CHIOU PHONE NO : 886 4 23596873
38, 34TH RD. SE DECISION MADE: 23-SEP-02
TAICHUNG INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
TAICHUNG CITY, CHINA (TAIWAN) 407
DEVICE: AGILTRAC .035 PERIPHERAL DILATATION CATHETER
GUIDANT CORP. 510(k) NO: K022738(SPECIAL)
ATTN: NADINE SAKAKINI PHONE NO : 650-617-5218
1525 O'BRIEN DR. SE DECISION MADE: 13-SEP-02
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500
GUIDANT CORP. 510(k) NO: K022880(SPECIAL)
ATTN: JEFF SCHAKENRAAD PHONE NO : 925-283-7559
3744 MT. DIABLO BLVD. SE DECISION MADE: 13-SEP-02
SUITE 305 510(k) SUMMARY AVAILABLE FROM FDA
LAFAYETTE, CA 94549 THIRD PARTY REVIEW
DEVICE: ENDOSCOPIC FIBEROPTIC CABLE
GULF MEDICAL FIBEROPTICS 510(k) NO: K021931(TRADITIONAL)
ATTN: MARCELINO AFANADOR PHONE NO : 813-855-6618
376 DOUGLAS ROAD SE DECISION MADE: 06-SEP-02
UNIT D 510(k) STATEMENT
OLDSMAR, FL 34677
DEVICE: SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'
HDC CORP. 510(k) NO: K022099(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, N.W. SE DECISION MADE: 20-SEP-02
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAICHEM LIPID CALIBRATOR
HEMAGEN DIAGNOSTICS, INC. 510(k) NO: K022767(SPECIAL)
ATTN: JOSE A MONTANEZ PHONE NO : 443-367-5518
9033 RED BRANCH RD. SE DECISION MADE: 03-SEP-02
COLUMBIA, MD 21045 510(k) STATEMENT
DEVICE: RAICHEM LDL-CHOLESTEROL DIRECT REAGENT
HEMAGEN DIAGNOSTICS, INC. 510(k) NO: K022772(TRADITIONAL)
ATTN: JOSE A MONTANEZ PHONE NO : 443-367-5518
9033 RED BRANCH RD. SE DECISION MADE: 17-SEP-02
COLUMBIA, MD 21045 510(k) STATEMENT
DEVICE: RESTORATION MODULAR SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K022549(TRADITIONAL)
ATTN: JENNIFER A DAUDELIN PHONE NO : 201-831-5379
59 ROUTE 17 SE DECISION MADE: 23-SEP-02
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DVT60
HUNTLEIGH HEALTHCARE, INC. 510(k) NO: K022786(SPECIAL)
ATTN: AUDREY WITKO PHONE NO : 001-732-5789
40 CHRISTOPHER WAY SE DECISION MADE: 19-SEP-02
EATONTOWN, NJ 07724-3327 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOAKER CATHETER
I-FLOW CORP. 510(k) NO: K022869(SPECIAL)
ATTN: SHANE NOEHRE PHONE NO : 949-206-2700
20202 WINDROW DR. SE DECISION MADE: 20-SEP-02
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UCR SPINAL SYSTEM, 5.5MM, 8.0MM SCREWS & INSTRUMENTS
IAME, INC. 510(k) NO: K021623(SPECIAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640
200 GREGORY LANE, SUITE C-100 SE DECISION MADE: 10-SEP-02
PLEASANT HILL, CA 94523-3389 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IGEL 55 TORIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FO
IGEL VISION CARE PTE LTD. 510(k) NO: K021907(TRADITIONAL)
ATTN: DEBBIE MCINTIRE PHONE NO : 209-612-4130
201 KING ARTHUR COURT SE DECISION MADE: 04-SEP-02
TRACY, CA 95376 510(k) STATEMENT
DEVICE: ICASE
IKEEPS, INC. 510(k) NO: K021248(TRADITIONAL)
ATTN: E. J. SMITH PHONE NO : 888-729-9674
P.O. BOX 4341 SE DECISION MADE: 24-SEP-02
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODEL
IMAGE-GUIDED NEUROLOGICS, INC. 510(k) NO: K022100(TRADITIONAL)
ATTN: DAVID M LEE PHONE NO : 321-309-8237
2290 W. EAU GALLIE BLVD SE DECISION MADE: 25-SEP-02
MELBOURNE, FL 32935 510(k) STATEMENT
DEVICE: MY ALLERGY TEST
IMMUNETECH CORPORATION 510(k) NO: K021698(TRADITIONAL)
ATTN: VIVIANNE NOETZEL PHONE NO : 858-756-8483
P.O. BOX 9433 SE DECISION MADE: 19-SEP-02
17394 VIA DEL BRAVO 510(k) SUMMARY AVAILABLE FROM FDA
RANCHO SANTA FE, CA 92067
DEVICE: CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518
IMMUNICON CORP. 510(k) NO: K022512(TRADITIONAL)
ATTN: PETER SCOTT PHONE NO : 215-830-0777
3401 MASONS MILL RD. STE 100 SE DECISION MADE: 30-SEP-02
HUNTINGTON VALLEY, PA 19006-3574 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3I DENTAL IMPLANT ACCESSORIES
IMPLANT INNOVATIONS, INC. 510(k) NO: K022113(TRADITIONAL)
ATTN: JEANNETTE G DAILEY PHONE NO : 561-776-6913
4555 RIVERSIDE DR. SE DECISION MADE: 19-SEP-02
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INION CPS 2.5/2.8 SCREW
INION LTD. 510(k) NO: K022981(SPECIAL)
ATTN: HANNA MARTTILA PHONE NO : 358 323 06600
LAAKARINKATU 2 SE DECISION MADE: 12-SEP-02
TAMPERE, FINLAND FIN-33520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACT III VENTRICULAR CATHETER
INNERSPACE, INC. 510(k) NO: K013705(TRADITIONAL)
ATTN: DONALD E BOBO PHONE NO : 949-752-8672
2933 SOUTH PULLMAN ST., SE DECISION MADE: 09-SEP-02
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
SANTA ANA, CA 92705
DEVICE: QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA
INOVA DIAGNOSTICS, INC. 510(k) NO: K021648(TRADITIONAL)
ATTN: BRYS C MYERS PHONE NO : 858-586-9900
10180 SCRIPPS RANCH BLVD. SE DECISION MADE: 20-SEP-02
SAN DIEGO, CA 92131 510(k) STATEMENT
DEVICE: DELTA 32; DELTA 32 TACT
INSTRUMENTARIUM CORP. IMAGING DIVI510(k) NO: K022275(TRADITIONAL)
ATTN: DARREN GREBE PHONE NO : 414-747-1030
300 WEST EDGERTON AVENUE SE DECISION MADE: 12-SEP-02
MILWAUKEE, WI 53207 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CV
INSTRUMENTATION LABORATORY CO. 510(k) NO: K022158(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 10-SEP-02
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVAGEN WOUND DRESSING
INTEGRA LIFESCIENCES CORP. 510(k) NO: K022127(TRADITIONAL)
ATTN: JUDITH E O'GRADY PHONE NO : 609-275-0500
311 ENTERPRISE DRIVE SE DECISION MADE: 10-SEP-02
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000
INTEGRA NEUROSCIENCES 510(k) NO: K021989(TRADITIONAL)
ATTN: NANCY MATHEWSON PHONE NO : 858-455-1115
5955 PACIFIC CENTER BLVD. SE DECISION MADE: 13-SEP-02
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER); IVS INTR
INTEGRATED VASCULAR SYSTEMS, INC. 510(k) NO: K020879(TRADITIONAL)
ATTN: SUSAN TURNER PHONE NO : 408-328-9090
743 NORTH PASTORIA AVENUE SE DECISION MADE: 25-SEP-02
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO INFANT LIFE SUPPORT MODULE-20
INTERNATIONAL BIOMEDICAL, INC. 510(k) NO: K022876(SPECIAL)
ATTN: GERLAD MANNING PHONE NO : 512-973-0033
8508 CROSS PARK DRIVE SE DECISION MADE: 11-SEP-02
AUSTIN, TX 78754 510(k) STATEMENT
DEVICE: IQ PRODUCTS TRIPLE-COLOR FLOW CYTOMETRY REAGENTS, IQ PRODUCTS CD
IQ CORP. 510(k) NO: K022528(TRADITIONAL)
ATTN: H.G. HAINES PHONE NO : 305-298-3349
11511 SW 127TH STREET SE DECISION MADE: 11-SEP-02
MIAMI, FL 33176 510(k) STATEMENT
DEVICE: IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96
IVD RESEARCH, INC. 510(k) NO: K020583(TRADITIONAL)
ATTN: DAVE LAMBILLOTTE PHONE NO : 760-929-7744
5909 SEA LION PLACE, SUITE D SE DECISION MADE: 17-SEP-02
CARLSBAD, CA 92008 510(k) STATEMENT
DEVICE: LDL CHOLESTEROL (AUTOMATED)
JAS DIAGNOSTIC, INC. 510(k) NO: K022519(TRADITIONAL)
ATTN: DAVID JOHNSTON PHONE NO : 305-418-2320
7220 NW 58TH ST. SE DECISION MADE: 30-SEP-02
MIAMI, FL 33166 510(k) STATEMENT
DEVICE: JOSTRA VENT CATHETERS, MODELS LV & HKV
JOSTRA AG 510(k) NO: K022022(TRADITIONAL)
ATTN: KATHLEEN JOHNSON PHONE NO : 610-932-7738
478 MEDIA ROAD SE DECISION MADE: 11-SEP-02
OXFORD, PA 19363 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PO
KAWASUMI LABORATORIES, INC. 510(k) NO: K022110(TRADITIONAL)
ATTN: JACK PAVLO PHONE NO : 813-630-5554
1800 MASSACHUSETTS AVE N.W. SE DECISION MADE: 12-SEP-02
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20036
DEVICE: LAP CT-4 CT SIMULATION ISOCENTER AND FIELD MARKING SYSTEM, MODEL
LAP OF AMERICA LASER APPLICATIONS,510(k) NO: K010216(TRADITIONAL)
ATTN: PIETER VAN ARKEL PHONE NO : 561-416-9250
1765 AVENIDA DEL SOL SE DECISION MADE: 26-SEP-02
BOCA RATON, FL 33432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMFY HIGH RISER WHEELCHAIR
LENJOY MEDICAL ENGINEERING, INC. 510(k) NO: K022617(TRADITIONAL)
ATTN: LEAH ROTTER PHONE NO : 310-353-2481
13721 GRAMERCY PL. SE DECISION MADE: 13-SEP-02
GARDENA, CA 90249-2469 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
LIFESCAN, INC. 510(k) NO: K022724(SPECIAL)
ATTN: JOHN E HUGHES PHONE NO : 408-942-5903
1000 GIBRALTAR DR. SE DECISION MADE: 12-SEP-02
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HARMONY INR MONITORING SYSTEM
LIFESCAN, INC. 510(k) NO: K022922(SPECIAL)
ATTN: JOHN E HUGHES PHONE NO : 408-942-5903
1000 GIBRALTAR DR. SE DECISION MADE: 30-SEP-02
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUCIUS 62
LUCIUS METALS COM. 510(k) NO: K021948(TRADITIONAL)
ATTN: DAE-KYU CHANG PHONE NO : 562-799-6626
4241 FARQUHAR AVE. #2 SE DECISION MADE: 03-SEP-02
LOS ALAMITOS, CA 90720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUNEAU 3 MIRROR LENS
LUNEAU SA 510(k) NO: K022413(TRADITIONAL)
ATTN: JEAN NOEL YOUNG PHONE NO : 33 0 237252525
BP 252 SE DECISION MADE: 24-SEP-02
CHARTRES CEDEX, FRANCE 28005 510(k) STATEMENT
DEVICE: DUOPRO SAFETY SYRINGE (DUOPROSS)
M.K. MEDITECH CO. LTD. 510(k) NO: K022806(SPECIAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 19-SEP-02
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MANUAL WHEELCHAIR
MAJOR MOBILITY PRODUCTS, INC. 510(k) NO: K022825(TRADITIONAL)
ATTN: GARRY BITTNER PHONE NO : 281-732-2870
17323 CANTON FOREST SE DECISION MADE: 13-SEP-02
RICHMOND, TX 77469 510(k) STATEMENT
DEVICE: MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE
MED-TEC,INC. 510(k) NO: K013875(TRADITIONAL)
ATTN: DONALD F RIIBE PHONE NO : 712-737-8688
1401 8TH STREET S.E. SE DECISION MADE: 27-SEP-02
P.O. BOX 320 510(k) STATEMENT
ORANGE CITY, IA 51041
DEVICE: COLOSHIELD COLONOSCOPY DRAPE MODEL E2000
MEDICAL CONCEPTS DEVELOPMENT, INC.510(k) NO: K020581(TRADITIONAL)
ATTN: ERIC EUTENEUER PHONE NO : 651-702-5152
2500 VENTURA DR. SE DECISION MADE: 18-SEP-02
WOODBURY, MN 55125-3927 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS
MEDICAL DEVICE SERVICES 510(k) NO: K022744(TRADITIONAL)
ATTN: MARK ALDANA PHONE NO : 806-745-7718
1001 SLATON HWY SE DECISION MADE: 18-SEP-02
LUBBOCK, TX 79404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SQA V, SPERM QUALITY ANALYZER
MEDICAL ELECTRONIC SYSTEMS, LLC 510(k) NO: K021746(TRADITIONAL)
ATTN: ERICA B AMMIRATI PHONE NO : 650-949-2768
269 SOUTH BEVERLY DRIVE SE DECISION MADE: 20-SEP-02
#472 510(k) STATEMENT
BEVERLY HILLS, CA 90212
DEVICE: MEDRAD TRANSFER SET
MEDRAD, INC. 510(k) NO: K022431(TRADITIONAL)
ATTN: FRANK W PELC III PHONE NO : 412-767-2400
ONE MEDRAD DR. SE DECISION MADE: 05-SEP-02
INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFEGUARD
MEDTEK LLC. 510(k) NO: K022755(TRADITIONAL)
ATTN: DEBORAH N BALLARD PHONE NO : 800-469-5395
10315B CHAPEL HILL RD. SE DECISION MADE: 24-SEP-02
MORRISVILLE, NC 27560 510(k) STATEMENT
DEVICE: PREMIER ANTERIOR CERVICAL PLATE SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K021761(SPECIAL)
ATTN: RICHARD TREHAME PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 17-SEP-02
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO TSRH SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K022778(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 18-SEP-02
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDX LCS LASER SERIES
MEDX ELECTRONICS, INC. 510(k) NO: K021985(TRADITIONAL)
ATTN: ANITA SALTMARCHE PHONE NO : 888 363 3112
3535 LAIRD ROAD SE DECISION MADE: 10-SEP-02
UNIT 2 510(k) SUMMARY AVAILABLE FROM FDA
MISSISSAUGA, CANADA L5L 5Y7
DEVICE: MICRORUPTER V
MERIDIAN AG 510(k) NO: K023045(TRADITIONAL)
ATTN: KURT FREY PHONE NO : 41 33 3341111
BIERIGUTSTRASSE 7 SE DECISION MADE: 26-SEP-02
THUN, BERN, SWITZERLAND 3608 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AUTO*THERM 395, MODEL ME 395
METTLER ELECTRONICS CORP. 510(k) NO: K022458(ABBREVIATED)
ATTN: ROBERT E FLEMING PHONE NO : 714-533-2221
1333 SOUTH CLAUDINA ST. SE DECISION MADE: 26-SEP-02
ANAHEIM, CA 92805 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TITAN MICRO CATHETER, MODEL 105-5074-153; HD INJECTOR, MODEL 103
MICRO THERAPEUTICS, INC. 510(k) NO: K022003(TRADITIONAL)
ATTN: BILL HYATT PHONE NO : 949-837-3700
2 GOODYEAR SE DECISION MADE: 13-SEP-02
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) W
MICROVENTION, INC. 510(k) NO: K022735(SPECIAL)
ATTN: VINCENT CUTAURELLI PHONE NO : 949-768-1184
72 ARGONAUT SE DECISION MADE: 06-SEP-02
ALISO VIEJO, CA 92656-1408 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TUBING, DIALYSATE (AND CONNECTOR)
MOLDED PRODUCTS INC. 510(k) NO: K022068(TRADITIONAL)
ATTN: ELISE JOHNSTON PHONE NO : 712-755-5557
601 DURANT ST. SE DECISION MADE: 23-SEP-02
HARLAN, IA 51537 510(k) STATEMENT
DEVICE: PULMOLAB EX671 EXERCISE TESTING SYSTEM
MORGAN MEDICAL LTD. 510(k) NO: K020280(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET NW SE DECISION MADE: 24-SEP-02
WASHINGTON, DC 20004-1109 510(k) STATEMENT
DEVICE: M2 SINGLE USE MICROKERTOME
MORIA S.A. 510(k) NO: K022560(TRADITIONAL)
ATTN: MELANIE RENAUD-SAMIRI PHONE NO : 331 467 44636
15 RUE GEORGES BESSE SE DECISION MADE: 27-SEP-02
ANTONY, FRANCE 92160 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-SCRIBE II
MORTARA INSTRUMENT, INC. 510(k) NO: K022618(SPECIAL)
ATTN: HARLAN VAN MATRE PHONE NO : 414-354-1600
7865 NORTH 86TH ST. SE DECISION MADE: 06-SEP-02
MILWAUKEE, WI 53224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HRW-63-INT WRIST ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K022588(SPECIAL)
ATTN: TOM SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SE DECISION MADE: 04-SEP-02
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: CTL-63-8 CERVICAL/THORACIC/LUMBAR SPINE ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K022720(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SE DECISION MADE: 06-SEP-02
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: HRK-63 KNEE ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K022883(SPECIAL)
ATTN: TOM SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SE DECISION MADE: 27-SEP-02
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: NATUS BLUE LIGHT PHOTOTHERAPY UNIT
NATUS MEDICAL, INC. 510(k) NO: K022196(TRADITIONAL)
ATTN: SHEILA RAMERMAN PHONE NO : 650-801-7328
1501 INDUSTRIAL RD. SE DECISION MADE: 19-SEP-02
SAN CARLOS, CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NELLCOR N-200 PULSE OXIMETER, MODEL N-200
NELLCOR PURITAN BENNETT, INC. 510(k) NO: K022819(SPECIAL)
ATTN: GINA TO PHONE NO : 925-463-4427
4280 HACIENDA DR. SE DECISION MADE: 24-SEP-02
PLEASANTON, CA 94588-2719 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAFD 100
NEOMATRIX, LLC 510(k) NO: K020848(TRADITIONAL)
ATTN: SALVADORE F PALOMARES PHONE NO : 949-753-7844
16 TECHNOLOGY DRIVE SE DECISION MADE: 23-SEP-02
SUITE 118 510(k) SUMMARY AVAILABLE FROM FDA
IRVINE, CA 92618
DEVICE: NESS SYSTEM
NESS-NEUROMUSCULAR ELECTRICAL STIM510(k) NO: K022776(SPECIAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 13TH STREET, N.W. SE DECISION MADE: 11-SEP-02
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43
NOBEL BIOCARE USA, INC. 510(k) NO: K022424(TRADITIONAL)
ATTN: RICHARD T ROSS PHONE NO : 714-282-4800
22715 SAVI RANCH PKWY. SE DECISION MADE: 27-SEP-02
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPLACE TIUNITE ENDOSSEOUS IMPLANT
NOBEL BIOCARE USA, INC. 510(k) NO: K023113(SPECIAL)
ATTN: HERBERT CRANE PHONE NO : 714-282-4800
22715 SAVI RANCH PKWY. SE DECISION MADE: 26-SEP-02
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPERNOVA DIAGNOSTIC ULTRASOUND SCANNING SYSTEM
NOVASONICS, INC. 510(k) NO: K022858(TRADITIONAL)
ATTN: CHERYL A BLAKE PHONE NO : 650-230-2715
1061 TERRA BELLA AVE. SE DECISION MADE: 06-SEP-02
MOUNTAIN VIES, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: KUSKE BREAST APPLICATOR SET, MODEL 189.006
NUCLETRON CORPORATION 510(k) NO: K022635(SPECIAL)
ATTN: LISA DIMMICK PHONE NO : 410-312-4100
7080 COLUMBIA GATEWAY DR. SE DECISION MADE: 06-SEP-02
COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PTA AND PTV
NUMED, INC. 510(k) NO: K022722(SPECIAL)
ATTN: NICHELLE R LAFLESH PHONE NO : 315-328-4491
2880 MAIN ST. SE DECISION MADE: 13-SEP-02
HOPKINTON, NY 12965 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTSTITCH SUTURE DEVICE, MODEL OM-8500
OPUS MEDICAL, INC. 510(k) NO: K022229(TRADITIONAL)
ATTN: JAMES W HART PHONE NO : 949-234-0400
27127 CALLE ARROYO, SUITE 1924 SE DECISION MADE: 06-SEP-02
SAN JUAN CAPISTRANO, CA 92675 510(k) STATEMENT
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND C
ORTHO-CLINICAL DIAGNOSTICS 510(k) NO: K022901(SPECIAL)
ATTN: MARLENE HANNA PHONE NO : 585-453-4041
100 INDIGO CREEK DRIVE SE DECISION MADE: 27-SEP-02
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HIP TOOL IMPLANT
ORTHOPEDIC SCIENCES, INC 510(k) NO: K022139(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
4329 GRAYDON ROAD SE DECISION MADE: 23-SEP-02
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NORMED MINI EXTERNAL FIXATOR SYSTEM
OSTEOMEDICS, INC. 510(k) NO: K022230(TRADITIONAL)
ATTN: ALBERT ENAYATI PHONE NO : 201-444-7306
809 CARTER LANE SE DECISION MADE: 10-SEP-02
PARAMUS, NJ 07652 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NORMED DISTAL RADIUS RECONSTRUCTION SYSTEM
OSTEOMEDICS, INC. 510(k) NO: K022231(TRADITIONAL)
ATTN: ALBERT ENAYATI PHONE NO : 201-444-7306
809 CARTER LANE SE DECISION MADE: 13-SEP-02
PARAMUS, NJ 07652 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NORMED TITANIUM RONDO FIX FUSION PLATES AND SCREW SYSTEM
OSTEOMEDICS, INC. 510(k) NO: K022323(TRADITIONAL)
ATTN: ALBERT ENAYATI PHONE NO : 201-444-7306
809 CARTER LANE SE DECISION MADE: 09-SEP-02
PARAMUS, NJ 07652 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NORMED TITANIUM CALCANEUS PLATING WITH LOCKING SCREW SYSTEM
OSTEOMEDICS, INC. 510(k) NO: K022324(TRADITIONAL)
ATTN: ALBERT ENAYATI PHONE NO : 201-444-7306
809 CARTER LANE SE DECISION MADE: 17-SEP-02
PARAMUS, NJ 07652 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NORMED TITANIUM OSTEOTOMY PLATING SYSTEM
OSTEOMEDICS, INC. 510(k) NO: K022325(TRADITIONAL)
ATTN: ALBERT ENAYATI PHONE NO : 201-444-7306
809 CARTER LANE SE DECISION MADE: 09-SEP-02
PARAMUS, NJ 07652 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOSOMNIA
OXFORD BIOSIGNALS LIMITED 510(k) NO: K021485(TRADITIONAL)
ATTN: PAUL A HOBDAY PHONE NO :
1468 HARWELL AVENUE SE DECISION MADE: 11-SEP-02
CROFTON, MD 21114-4341 510(k) STATEMENT
DEVICE: EBV EA-D IGG ELISA KIT, MODEL EBG-100
PAN BIO PTY. LTD. 510(k) NO: K021793(TRADITIONAL)
ATTN: HELEN JENNINGS PHONE NO : 61 7 33571177
116 LUTWYCHE RD. SE DECISION MADE: 27-SEP-02
WINDSOR 510(k) SUMMARY AVAILABLE FROM FDA
BRISBANE, QUEENSLAND, AUSTRALIA 4030
DEVICE: THERMIQUE
PARKELL, INC. 510(k) NO: K022097(TRADITIONAL)
ATTN: DANIEL R SCHECHTER PHONE NO : 631-249-1134
155 SCHMITT BLVD. SE DECISION MADE: 06-SEP-02
FARMINGDALE, NY 11735 510(k) STATEMENT
DEVICE: FG-36UX FIBER ULTRASOUND GASTROSCOPE
PENTAX PRECISION INSTRUMENT CORP. 510(k) NO: K021276(TRADITIONAL)
ATTN: PAUL SILVA PHONE NO : 845-365-0700
30 RAMLAND RD. SE DECISION MADE: 12-SEP-02
ORANGEBURG, NY 10962 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE
PENTAX PRECISION INSTRUMENT CORP. 510(k) NO: K021278(TRADITIONAL)
ATTN: PAUL SILVA PHONE NO : 845-365-0700
30 RAMLAND RD. SE DECISION MADE: 06-SEP-02
ORANGEBURG, NY 10962 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE, LATEX EXAMINATION GLOVE COATED WITH ALOE VERA GEL A
PERUSAHAAN GETAH ASAS SDN BHD 510(k) NO: K022701(TRADITIONAL)
ATTN: TAN KONG CHANG PHONE NO : 603 329 11949
LOT 754, JALAN HAJI SIRAT SE DECISION MADE: 17-SEP-02
SELANGOR, MALAYSIA 41720 510(k) STATEMENT
DEVICE: FERTILITE OV
PHEROMONE SCIENCES CORP. 510(k) NO: K020808(TRADITIONAL)
ATTN: JEFFREY T SOLATE PHONE NO : 416 861 9854
443 KING ST. EAST 2ND FL SE DECISION MADE: 23-SEP-02
TORONTO, CANADA M5A 1L5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M2376A DEVICELINK SYSTEM
PHILIPS MEDICAL SYSTEMS 510(k) NO: K022920(SPECIAL)
ATTN: BARRY WYSHOGROD PHONE NO : 978-659-7383
3000 MINUTEMAN RD. MS 0490 SE DECISION MADE: 17-SEP-02
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACQPLAN 5.0
PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K013644(TRADITIONAL)
ATTN: ROBERT L TUROCY PHONE NO : 440-483-3528
595 MINER ROAD SE DECISION MADE: 12-SEP-02
HIGHLAND HGTS., OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STAYFUSE GT-IP
PIONEER SURGICAL TECHNOLOGY 510(k) NO: K022726(TRADITIONAL)
ATTN: KATHY MORAN PHONE NO : 906-226-9909
375 RIVER PARK CIRCLE SE DECISION MADE: 06-SEP-02
MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO PLAYTEX TAMPONS #24002
PLAYTEX PRODUCTS, INC. 510(k) NO: K022882(SPECIAL)
ATTN: PAUL A SIRACUSA PHONE NO : 201-785-8101
75 COMMERCE DR. SE DECISION MADE: 16-SEP-02
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MALE LATEX CONDOM WITH DOTTED/RIBBED SURFACE AND COUNOUR-WALLED
PLEASURE LATEX PRODUCTS SDN. BHD. 510(k) NO: K021875(ABBREVIATED)
ATTN: KOI-YONG LIM PHONE NO : 603 326 40784
LOT 1365, 17TH MILES, JALAN SE DECISION MADE: 05-SEP-02
SUNGAI SEMBILANG 510(k) STATEMENT
JERAM, SELANGOR, MALAYSIA 45800
DEVICE: PTS PANELS LIPID PANEL TEST STRIPS
POLYMER TECHNOLOGY SYSTEMS, INC. 510(k) NO: K022898(SPECIAL)
ATTN: MARGO ENRIGHT PHONE NO : 317-870-5610
7736 ZIONSVILLE RD. SE DECISION MADE: 24-SEP-02
INDIANAPOLIS, IN 46268 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECISEPLAN 2.0
PRECISION THERAPY INTL., INC. 510(k) NO: K022411(TRADITIONAL)
ATTN: PETER STEGAGNO PHONE NO : 770-300-9725
3155 NORTHWOODS PKWY NW SE DECISION MADE: 20-SEP-02
NORCROSS, GA 30071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136
PRIMELINE MEDICAL PRODUCTS, INC. 510(k) NO: K021864(TRADITIONAL)
ATTN: BRENDA LEE PHONE NO : 780 497 7600
10707 100TH AVE., SUITE 300 SE DECISION MADE: 23-SEP-02
EDMONTON, ALBERTA, CANADA T5J 3M1 510(k) STATEMENT
DEVICE: GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE (PROT
PT. WRP BUANA MULTICORPORA 510(k) NO: K022343(TRADITIONAL)
ATTN: NG POY SIN PHONE NO : 62 61 6942461
JALAN JERMAL #20B, KELURAHAN SE DECISION MADE: 16-SEP-02
SEI MATI, MEDAN LABUHAN KM 17 510(k) SUMMARY AVAILABLE FROM FDA
MEDAN, INDONESIA 20252
DEVICE: PULPDENT PUTTY DAM
PULPDENT CORPORATION 510(k) NO: K022522(TRADITIONAL)
ATTN: KENNETH J BERK PHONE NO : 617-926-6666
80 OAKLAND STREET SE DECISION MADE: 26-SEP-02
WATERTOWN, MA 02472 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM
PURITAN BENNETT CORP. 510(k) NO: K022103(SPECIAL)
ATTN: JAMES BONDS PHONE NO : 925-463-4371
2200 FARADAY AVE. SE DECISION MADE: 27-SEP-02
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ILLUSION POWDER FREE-PLOYMER COATED COLOR SCENTED NR LATEX EXAMI
PURNABINA SDN BHD 510(k) NO: K022659(TRADITIONAL)
ATTN: LIEW YOON FONG PHONE NO : 607 787 9128
PLO 5, JALAN MAHSURI 1, 7.5KM SE DECISION MADE: 25-SEP-02
J. MERSING, KLUANG IND. AREA 510(k) SUMMARY AVAILABLE FROM FDA
KLUANG, JOHOR, MALAYSIA 86007
DEVICE: FASTPACK TESTOSTERONE CALIBRATOR
QUALIGEN, INC. 510(k) NO: K022533(ABBREVIATED)
ATTN: DOROTHY DEINZER PHONE NO : 760-918-9165
2042 CORTE DEL NOGAL SE DECISION MADE: 30-SEP-02
CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PH AND AMINES EXTERNAL CONTROL SET
QUIDEL CORP. 510(k) NO: K022851(TRADITIONAL)
ATTN: ROBIN WEINER PHONE NO : 858-552-7908
10165 MCKELLAR CT. SE DECISION MADE: 27-SEP-02
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUINTON Q-CATH, MODEL 000460
QUINTON, INC. 510(k) NO: K021906(ABBREVIATED)
ATTN: KAREN BROWNE PHONE NO : 425-402-2255
3303 MONTE VILLA PKWY. SE DECISION MADE: 04-SEP-02
BOTHELL, WA 98021-8906 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304
RADI MEDICAL SYSTEMS AB 510(k) NO: K022187(TRADITIONAL)
ATTN: MATS GRANLUND PHONE NO : 461 816 10000
PALMBLADSGATAN 10 SE DECISION MADE: 24-SEP-02
UPPSALA, SWEDEN S-754 50 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIONICS POLE NEEDLES
RADIONICS, A DIVISION OF TYCO HEAL510(k) NO: K021942(TRADITIONAL)
ATTN: KEVIN J O'CONNELL PHONE NO : 800-466-6814
22 TERRY AVE. SE DECISION MADE: 11-SEP-02
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND
RICH-MAR CORP. 510(k) NO: K021483(TRADITIONAL)
ATTN: DAVID RICHARDS PHONE NO : 918-543-2222
P.O. BOX 879 SE DECISION MADE: 13-SEP-02
INOLA, OK 74036 510(k) STATEMENT
DEVICE: RIWO NET OPERATING OPERATING CONTROL SYSTEM, MODEL #5590
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K020255(TRADITIONAL)
ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY. SE DECISION MADE: 18-SEP-02
VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXTERNAL FIXATION RING
RIGID FX ORTHOPEDICS, INCORPORATED510(k) NO: K022423(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-388-4694
1001 OAKWOOD BLVD SE DECISION MADE: 17-SEP-02
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS CORTISOL TEST SYSTEM
ROCHE DIAGNOSTICS CORP. 510(k) NO: K021218(TRADITIONAL)
ATTN: SHERRI L COENEN PHONE NO : 317-521-3831
9115 HAGUE ROAD SE DECISION MADE: 09-SEP-02
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SANIDAD THERMAL FAR-INFRARED WAVE LAMP, MODEL AP-2018
ROLOR ELECTRONICS CORP. 510(k) NO: K020462(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 352 08829
NO. 58 FU-CHIUN ST. SE DECISION MADE: 16-SEP-02
HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: SANIDAD FAR-INFRARED MINI LAMP, MODEL FI-3646
ROLOR ELECTRONICS CORP. 510(k) NO: K020464(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 352 08829
NO. 58 FU-CHIUN ST. SE DECISION MADE: 17-SEP-02
HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: INJEX NEEDLE-FREE INJECTION SYSTEM; ROJEX NEEDLE-FREE INJECTION
ROSCH AG MEDIZINTECHNIC 510(k) NO: K020786(TRADITIONAL)
ATTN: KERSTIN ZALEWSKI PHONE NO : 30 667 915957
BUCKOWER DAMM 114 SE DECISION MADE: 25-SEP-02
BERLIN, GERMANY D-12349 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY
SANARUS MEDICAL, INC. 510(k) NO: K022879(SPECIAL)
ATTN: VINCENT CUTARELLI PHONE NO : 949-595-5424
5880 WEST LAS POSITAS,SUITE 52 SE DECISION MADE: 23-SEP-02
PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIS
SCHWARZER GMBH 510(k) NO: K023015(TRADITIONAL)
ATTN: EIKE KINZEL PHONE NO : 49 89 83942-158
BAERMANNSTRASSE 38 SE DECISION MADE: 25-SEP-02
MUNICH, GERMANY D-81245 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CASHMERE POWDER FREE LATEX EXAMINATION GLOVES (POLYMER COATED ON
SEAL POLYMER INDUSTRIES SDN. BHD. 510(k) NO: K022792(TRADITIONAL)
ATTN: CHUN CHOOI FONG PHONE NO : 60 5 3223200
LT 72706, JALAN LAHAT, KAWASAN SE DECISION MADE: 26-SEP-02
PERINDUSTRIAN BUKIT MERAH 510(k) SUMMARY AVAILABLE FROM FDA
LAHAT, IPOH, PERAK, MALAYSIA 31500
DEVICE: POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
SHEN WEI (USA), INC. 510(k) NO: K022220(TRADITIONAL)
ATTN: BELLE L CHOU PHONE NO : 510-429-8692
2845 WHIPPLE RD. SE DECISION MADE: 23-SEP-02
UNION CITY, CA 94587 510(k) STATEMENT
DEVICE: SYNTHETIC POWDER FREE VINYL PATIENT EXAM GLOVES
SHIJIAZHUANG HOLY PLASTICS CO., LT510(k) NO: K022639(TRADITIONAL)
ATTN: ANTONIO L GIACCIO PHONE NO : 815-385-0100
1202 S. RTE. 31 SE DECISION MADE: 16-SEP-02
MCHENRY, IL 60050 510(k) STATEMENT
DEVICE: POWDERED SYNTHETIC VINYL EXAM GLOVES
SHIJIAZHUANG HOLY PLASTICS CO., LT510(k) NO: K022702(TRADITIONAL)
ATTN: ANTONIO L GIACCIO PHONE NO : 815-385-0100
1202 S. RTE. 31 SE DECISION MADE: 16-SEP-02
MCHENRY, IL 60050 510(k) STATEMENT
DEVICE: POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES
SHIJIAZHUANG WALLY PLASTICS CO., L510(k) NO: K022600(TRADITIONAL)
ATTN: ANTONIO L GIACCIO PHONE NO : 815-385-0100
1202 S. RTE 31 SE DECISION MADE: 16-SEP-02
MC HENRY, IL 60050 510(k) STATEMENT
DEVICE: SERVO VENTILATOR SYSTEM, MODEL 64 87 800 E407E
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K022132(SPECIAL)
ATTN: RICHARD FLYNN PHONE NO : 508-750-7500
16 ELECTRONICS AVE. SE DECISION MADE: 19-SEP-02
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIEMENS MEDICAL INFORMATION BUS (MIB/MIB II/MIB DUO) PROTOCOL CO
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K022766(SPECIAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 05-SEP-02
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 & SC
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K022889(SPECIAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 25-SEP-02
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTIPLE, POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT
SMART GLOVE CORP. SDN BHD 510(k) NO: K022818(TRADITIONAL)
ATTN: FOO KHON PU PHONE NO : 603 329 16100
LOT 6487 BATU 5 3/4 SE DECISION MADE: 17-SEP-02
JALAN KAPAR 510(k) STATEMENT
KLANG SELANGOR, MALAYSIA 42100
DEVICE: ORTHOGUARD AB ANTIMICROBIAL SLEEVE
SMITH & NEPHEW, INC. 510(k) NO: K022676(SPECIAL)
ATTN: JANET JOHNSON GREEN PHONE NO : 901-399-5153
1450 E. BROOKS ROAD SE DECISION MADE: 23-SEP-02
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOUNDVASER SYSTEM
SOUND SURGICAL TECHNOLOGIES LLC. 510(k) NO: K022051(TRADITIONAL)
ATTN: WILLIAM W CIMINO PHONE NO : 303-926-8608
1300 PLAZA CT. NORTH, #103 SE DECISION MADE: 11-SEP-02
LAFAYETTE, CO 80026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST
SPECTRAL DIAGNOSTICS, INC. 510(k) NO: K022409(TRADITIONAL)
ATTN: NISAR A SHAIKH PHONE NO : 416 626 3233
135-2 THE WEST MALL SE DECISION MADE: 30-SEP-02
TORONTO, ONTARIO, CANADA M9C1C2 510(k) STATEMENT
DEVICE: SPECTRANETICS 0.035" SUPPORT CATHETER, MODEL 518-028
SPECTRANETICS CORP. 510(k) NO: K022138(TRADITIONAL)
ATTN: MICHAEL J RYAN PHONE NO : 719-633-8333
96 TALAMINE CT. SE DECISION MADE: 23-SEP-02
COLORADO SPRINGS, CO 80907-5159 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLUS PIVOT LINK UNIVERSAL SYSTEM
SPINEVISION, INC. 510(k) NO: K022271(TRADITIONAL)
ATTN: LYNNETTE WHITAKER PHONE NO : 574-269-9776
3003 SUMMIT BLVD. SE DECISION MADE: 23-SEP-02
SUITE 1400 510(k) SUMMARY AVAILABLE FROM FDA
ATLANTA, GA 30319
DEVICE: SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND)
ST. JUDE MEDICAL, INC. 510(k) NO: K022363(SPECIAL)
ATTN: WILLIAM MCKELVY PHONE NO : 651-415-7029
ONE LILLEHEI PLAZA SE DECISION MADE: 19-SEP-02
ST. PAUL, MN 55117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILOX LIQUID CHEMICAL STERILANT SYSTEM
STERILOX TECHNOLOGIES, INC. 510(k) NO: K013280(TRADITIONAL)
ATTN: HOWARD MANN PHONE NO : 215-369-3130
HESTON HALL/CARRIAGE HOUSE SE DECISION MADE: 18-SEP-02
1790 YARDLEY-LANGHORNE ROAD 510(k) SUMMARY AVAILABLE FROM FDA
YARDLEY, PA 19067 THIRD PARTY REVIEW
DEVICE: STERNGOLD 1, MODEL 1127781
STERNGOLD 510(k) NO: K022252(ABBREVIATED)
ATTN: MARIA RAO PHONE NO : 508-226-5660
23 FRANK MOSSBERG DR. SE DECISION MADE: 19-SEP-02
ATTLEBORO, MA 02703-0967 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DAYTRIPPER DIALYSATE WARMER
STICKMAN INDUSTRIES INC. 510(k) NO: K020542(TRADITIONAL)
ATTN: JEAN CLERMONT PHONE NO : 613 722 9059
320 LANARK AVENUE SE DECISION MADE: 27-SEP-02
OTTAWA, ONTARIO, CANADA K1Z 6R5 510(k) STATEMENT
DEVICE: STOCKERT CENTRIFUGAL PUMP CONSOLE
STOCKERT INSTRUMENTE GMBH 510(k) NO: K020571(TRADITIONAL)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 23-SEP-02
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABUTMENT AND PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SY
STRAUMANN USA 510(k) NO: K022859(SPECIAL)
ATTN: LINDA JALBERT PHONE NO : 800-448-8168
RESERVOIR PLACE, SE DECISION MADE: 19-SEP-02
1601 TRAPELO ROAD 510(k) SUMMARY AVAILABLE FROM FDA
WALTHAM, MA 02154
DEVICE: LOCKING RECONSTRUCTION PLATE WITH ATTACHABLE CONDYLAR HEAD
STRYKER INSTRUMENTS 510(k) NO: K020199(TRADITIONAL)
ATTN: ROBIN L ROWE PHONE NO : 616-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 25-SEP-02
KALAMAZOO, MI 49001-6197 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CADENCE SPINAL FIXATION SYSTEM
SULZER SPINE-TECH 510(k) NO: K022374(SPECIAL)
ATTN: KRISTYN M BENSON PHONE NO : 952-830-6273
7375 BUSH LAKE RD. SE DECISION MADE: 24-SEP-02
MINNEAPOLIS, MN 55439-2027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGN IM NAIL
SURGICAL IMPLANT GENERATION NETWOR510(k) NO: K022632(TRADITIONAL)
ATTN: DOUG DONNELLY PHONE NO : 509-371-1107
2950 GEORGE WASHINGTON WAY SE DECISION MADE: 23-SEP-02
RICHLAND, WA 99352-1615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE
SYNTEX HEALTHCARE PRODUCTS CO. LTD510(k) NO: K022088(TRADITIONAL)
ATTN: TAN SWU CHOON PHONE NO : 86 311 3270666
NO. 1 FANJIAZHUNG INDUSTRIAL SE DECISION MADE: 03-SEP-02
ZONE 510(k) STATEMENT
XINJI CITY, HEBEI PROVINCE, CHINA 052360
DEVICE: SYNTEX PRE-POWDERED NITRILE EXAMINATION GLOVE
SYNTEX HEALTHCARE PRODUCTS CO. LTD510(k) NO: K022090(TRADITIONAL)
ATTN: TAN SWU CHOON PHONE NO : 86 311 3270666
NO. 1 FANJIAZHUNG INDUSTRIAL SE DECISION MADE: 03-SEP-02
ZONE 510(k) STATEMENT
XINJI CITY, HEBEI PROVINCE, CHINA 052360
DEVICE: SYNTEX PRE-POWDERED LATEX EXAMINATION GLOVE
SYNTEX HEALTHCARE PRODUCTS CO. LTD510(k) NO: K022092(TRADITIONAL)
ATTN: TAN SWU CHOON PHONE NO : 86 311 3270666
NO. 1 FANJIAZHUNG INDUSTRIAL SE DECISION MADE: 03-SEP-02
ZONE 510(k) STATEMENT
XINJI CITY, HEBEI PROVINCE, CHINA 052360
DEVICE: SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE
SYNTEX HEALTHCARE PRODUCTS CO. LTD510(k) NO: K022146(TRADITIONAL)
ATTN: TAN SWU CHOON PHONE NO : 86 311 3270666
NO. 1 FANJIAZHUNG INDUSTRIAL SE DECISION MADE: 03-SEP-02
ZONE 510(k) STATEMENT
XINJI CITY, HEBEI PROVINCE, CHINA 052360
DEVICE: SYNTHES (USA) RESORBABLE FIXATION SYSTEM
SYNTHES (USA) 510(k) NO: K021928(TRADITIONAL)
ATTN: BONNIE J SMITH PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 06-SEP-02
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES 6.5 MM CANNULATED SCREW
SYNTHES (USA) 510(k) NO: K021932(TRADITIONAL)
ATTN: BONNIE J SMITH PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 06-SEP-02
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES MIDFACE DISTRACTOR
SYNTHES (USA) 510(k) NO: K022005(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 03-SEP-02
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOMOSTICK SAFETY SYRINGE (FA12 SERIES 3ML/FA13 SERIES 5ML)
TAIJECT MEDICAL DEVICE CO., LTD. 510(k) NO: K022278(TRADITIONAL)
ATTN: JIM-SON CHOU PHONE NO : 949-294-6458
P.O. BOX 8853 SE DECISION MADE: 12-SEP-02
NEWPORT BEACH, CA 92658 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PUMP TUBING WITH X-COATING
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K022857(SPECIAL)
ATTN: KAZUHITO INOUE PHONE NO : 800-283-7866
125 BLUE BALL ROAD SE DECISION MADE: 19-SEP-02
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOI
TERUMO CORP. 510(k) NO: K022115(TRADITIONAL)
ATTN: GARRY A COURTNEY PHONE NO : 800-283-7866
125 BLUE BALL RD SE DECISION MADE: 27-SEP-02
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AB BELT
THE DEZAC GROUP 510(k) NO: K020427(TRADITIONAL)
ATTN: WENDY PARSLEY PHONE NO : 202-546-1262
719 A STREET NE SE DECISION MADE: 13-SEP-02
WASHINGTON, DC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AB BELT PRO
THE DEZAC GROUP 510(k) NO: K020429(TRADITIONAL)
ATTN: WENDY PARSLEY PHONE NO : 202-546-1262
719 A STREET NE SE DECISION MADE: 13-SEP-02
WASHINGTON, DC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONDUCTIVE GEL
THE DEZAC GROUP 510(k) NO: K022006(TRADITIONAL)
ATTN: WENDY PARSLEY PHONE NO : 202-546-1262
719 A STREET NE SE DECISION MADE: 13-SEP-02
WASHINGTON, DC 20002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RSV OIA
THERMO BIOSTAR, INC. 510(k) NO: K021172(TRADITIONAL)
ATTN: KOHN G ADAMS PHONE NO : 303-530-3888
6655 LOOKOUT RD. SE DECISION MADE: 13-SEP-02
BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K021997(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-216-9036
29299 CLEMENS RD., SUITE 1-K SE DECISION MADE: 25-SEP-02
WESTLAKE, OH 44145 510(k) STATEMENT
DEVICE: SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K022775(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-216-9036
29299 CLEMENS RD., SUITE 1-K SE DECISION MADE: 25-SEP-02
WESTLAKE, OH 44145 510(k) STATEMENT
DEVICE: HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, MODEL 7.3MM
TRIAD MEDICAL, INC. 510(k) NO: K022647(SPECIAL)
ATTN: BRAD CULBERT PHONE NO : 949-472-0006
13700 ALTON PKWY., SUITE 167 SE DECISION MADE: 05-SEP-02
IRVINE, CA 92618 510(k) STATEMENT
DEVICE: RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30;
TRIMEDYNE, INC. 510(k) NO: K013974(TRADITIONAL)
ATTN: SUSAN H GAMBLE PHONE NO : 949-559-5300
15091 BAKE PKWY. SE DECISION MADE: 23-SEP-02
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTI GUARD HOME INSULIN SYRINGE CONTAINER
ULTI MED, INC. 510(k) NO: K021983(TRADITIONAL)
ATTN: CHARLES W ERICKSON PHONE NO : 651-291-7909
287 EAST SIXTH ST. SE DECISION MADE: 16-SEP-02
ST. PAUL, MN 55101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: P4 PHYSIO
VALMED CORP. 510(k) NO: K022175(TRADITIONAL)
ATTN: GUY POITOUT PHONE NO : 561-841-2448
5080 NORTH OCEAN DRIVE 1A SE DECISION MADE: 09-SEP-02
SINGER ISLAND, FL 33404 510(k) STATEMENT
DEVICE: TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02
VASCULAR CONTROL SYSTEMS, INC 510(k) NO: K023024(TRADITIONAL)
ATTN: AL MEMMOLO PHONE NO : 949-488-8700
32236- E PASEO ADELANTO SE DECISION MADE: 26-SEP-02
SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VERTIS PNT CONTROL UNIT, MODEL CU 100; VERTIS PNT SAFEGUIDE-CERV
VERTIS NEUROSCIENCE, INC. 510(k) NO: K022241(TRADITIONAL)
ATTN: LORI GLASTETTER PHONE NO : 206-902-1902
2101 FOURTH AVENUE,SUITE 200 SE DECISION MADE: 11-SEP-02
SEATTLE, WA 98121-2329 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIATRONIX V3D EXPLORER
VIATRONIX, INC. 510(k) NO: K022789(TRADITIONAL)
ATTN: JEFF D RONGERO PHONE NO : 919-549-1922
12 LABORATORY DRIVE SE DECISION MADE: 06-SEP-02
RESEARCH TRIANGLE PARK, NC 27709 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VIDENT HEXTOP, SYNOCTA IN-CERAM BLANK/COPING MANUFACTURED BY VID
VIDENT 510(k) NO: K012473(TRADITIONAL)
ATTN: BARBARA J LEWANDOWSKI PHONE NO : 714-961-6200
3150 EAST BIRCH ST. SE DECISION MADE: 11-SEP-02
BREA, CA 92821 510(k) STATEMENT
DEVICE: G-2 VERSION 3, MODEL 10049
VITROLIFE SWEDEN AB 510(k) NO: K021890(TRADITIONAL)
ATTN: GARY L YINGLING PHONE NO : 202-778-9124
1800 MASSACHUSETTS AVENUE NW SE DECISION MADE: 06-SEP-02
WASHINGTON, DC 20036-1800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G-MOPS, MODEL 10030
VITROLIFE SWEDEN AB 510(k) NO: K021893(TRADITIONAL)
ATTN: GARY L YINGLING PHONE NO : 202-778-9124
1800 MASSACHUSETTS AVENUE NW SE DECISION MADE: 06-SEP-02
WASHINGTON, DC 20036-1800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G-MM, MODEL 10038
VITROLIFE SWEDEN AB 510(k) NO: K021894(TRADITIONAL)
ATTN: GARY L YINGLING PHONE NO : 202-778-9124
1800 MASSACHUSETTS AVENUE NW SE DECISION MADE: 06-SEP-02
WASHINGTON, DC 20036-1800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HSA-SOLUTION, MODEL 10034/10064
VITROLIFE SWEDEN AB 510(k) NO: K021896(TRADITIONAL)
ATTN: GARY L YINGLING PHONE NO : 202-778-9124
1800 MASSACHUSETTS AVENUE NW SE DECISION MADE: 06-SEP-02
WASHINGTON, DC 20036-1800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G-1 VERSION 3, MODEL 10048
VITROLIFE SWEDEN AB 510(k) NO: K022244(TRADITIONAL)
ATTN: GARY L YINGLING PHONE NO : 202-778-9124
1800 MASSACHUSETTS AVENUE NW SE DECISION MADE: 06-SEP-02
WASHINGTON, DC 20036-1800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G-FERT, MODEL 10033
VITROLIFE SWEDEN AB 510(k) NO: K022245(TRADITIONAL)
ATTN: GARY L YINGLING PHONE NO : 202-778-9124
1800 MASSACHUSETTS AVENUE NW SE DECISION MADE: 06-SEP-02
WASHINGTON, DC 20036-1800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G-SPERM, MODEL 10032
VITROLIFE SWEDEN AB 510(k) NO: K022247(TRADITIONAL)
ATTN: GARY L YINGLING PHONE NO : 202-778-9124
1800 MASSACHUSETTS AVENUE NW SE DECISION MADE: 06-SEP-02
WASHINGTON, DC 20036-1800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G-RINSE, MODEL 10031
VITROLIFE SWEDEN AB 510(k) NO: K022295(TRADITIONAL)
ATTN: EILER ANDERSON PHONE NO : 46 31 7218030
MOLNDALSVAGEN 30 SE DECISION MADE: 12-SEP-02
GOTHENBURG, SWEDEN SE-412 63 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VOMED ENDOSCOPIC AND UROLOGICAL ACCESSORIES
VOMED VOLZER MEDIZINTECHNIK GMBH &510(k) NO: K022318(TRADITIONAL)
ATTN: DAGMAR MASER PHONE NO : 312 042 89591
AMSTEL 320-I SE DECISION MADE: 19-SEP-02
AMSTERDAM, NETHERLANDS 1017AP 510(k) STATEMENT
DEVICE: DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL
W.L. GORE & ASSOCIATES,INC 510(k) NO: K022782(SPECIAL)
ATTN: R. LARRY PRATT PHONE NO : 928-779-2771
3750 WEST KILTIE LN. SE DECISION MADE: 10-SEP-02
FLAGSTAFF, AZ 86002-0900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET
WAKO CHEMICALS, USA, INC. 510(k) NO: K020972(TRADITIONAL)
ATTN: TONYA MALLORY PHONE NO : 800-992-9256
1600 BELLWOOD RD. SE DECISION MADE: 09-SEP-02
RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLAS MONITOR, MODELS 200,210,220
WELCH ALLYN, INC. 510(k) NO: K022084(SPECIAL)
ATTN: SHAWN EARLE PHONE NO : 315-685-3659
4341 STATE STREET RD. SE DECISION MADE: 26-SEP-02
SKANEATELES FALLS, NY 13153-0220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WELCH ALLYN SPOT VITAL SIGN MONITOR WITH MP506
WELCH ALLYN, INC. 510(k) NO: K022163(SPECIAL)
ATTN: DAVID KLEMENTOWSKI PHONE NO : 315-685-4100
4341 STATE STREET RD. SE DECISION MADE: 17-SEP-02
SKANEATELES FALLS, NY 13153-0220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WHISPER WEAR BREAST PUMP
WHISPER WEAR 510(k) NO: K022140(TRADITIONAL)
ATTN: AL WEISENBORN PHONE NO : 305-829-3437
19526 EAST LAKE DRIVE SE DECISION MADE: 30-SEP-02
MIAMI, FL 33015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUROPAL SOLDER W-2
WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K022451(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 49 723 13705219
SCHWENNINGER STRASSE 13 SE DECISION MADE: 11-SEP-02
PFORZHEIM, GERMANY D 75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTA OP SOLDER M-1
WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K022452(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 49 723 13705219
SCHWENNINGER STRASSE 13 SE DECISION MADE: 11-SEP-02
PFORZHEIM, GERMANY D 75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTA OP SOLDER W-2
WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K022454(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 49 723 13705219
SCHWENNINGER STRASSE 13 SE DECISION MADE: 12-SEP-02
PFORZHEIM, GERMANY D 75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTA IP SOLDER V-1
WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K022456(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 49 723 13705219
SCHWENNINGER STRASSE 13 SE DECISION MADE: 17-SEP-02
PFORZHEIM, GERMANY D 75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTA OPTIMUM SOLDER 710
WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K022457(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 49 723 13705219
SCHWENNINGER STRASSE 13 SE DECISION MADE: 17-SEP-02
PFORZHEIM, GERMANY D 75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUROPAL SOLDER M-1
WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K022459(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 49 723 13705219
SCHWENNINGER STRASSE 13 SE DECISION MADE: 12-SEP-02
PFORZHEIM, GERMANY D 75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPORTA SOLDER 1020
WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K022462(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 49 723 13705219
SCHWENNINGER STRASSE 13 SE DECISION MADE: 18-SEP-02
PFORZHEIM, GERMANY D 75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTA IP SOLDER V-2
WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K022467(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 49 723 13705219
SCHWENNINGER STRASSE 13 SE DECISION MADE: 17-SEP-02
PFORZHEIM, GERMANY D 75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTA OPTIMUM SOLDER 900
WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K022468(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 49 723 13705219
SCHWENNINGER STRASSE 13 SE DECISION MADE: 17-SEP-02
PFORZHEIM, GERMANY D 75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECO E4
WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K022469(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 49 723 13705219
SCHWENNINGER STRASSE 13 SE DECISION MADE: 18-SEP-02
PFORZHEIM, GERMANY D 75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTA SOLDER 1080 W
WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K022470(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 49 723 13705219
SCHWENNINGER STRASSE 13 SE DECISION MADE: 18-SEP-02
PFORZHEIM, GERMANY D 75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152
WIENER LABORATORIES S.A.I.C. 510(k) NO: K021334(TRADITIONAL)
ATTN: VIVIANA CETOLA PHONE NO : 543 414 329191
2944 RIOBAMBA SE DECISION MADE: 10-SEP-02
ROSARIO, ARGENTINA 2000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MADETT
WOLFE TORY MEDICAL, INC. 510(k) NO: K021044(TRADITIONAL)
ATTN: TIM WOLFE PHONE NO : 801-281-3000
79 WEST 4500 SOUTH, SUITE 16 SE DECISION MADE: 11-SEP-02
SALT LAKE CITY, UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE GREEN LATEX SURGICAL GLOVES, STERILE WITH ALOE VERA
WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K022442(TRADITIONAL)
ATTN: YUE WAH CHOW PHONE NO : 603 870 61486
LOT 1, JALAN 3, SE DECISION MADE: 05-SEP-02
KAWASAN PERUSAHAAN BANDAR BARU 510(k) SUMMARY AVAILABLE FROM FDA
SALAK TINGGI, SEPANG SELANGOR, MALAYSIA 43900
DEVICE: POWDER FREE GREEN NEOPRENE SURGICAL GLOVES, STERILE WITH ALOE VE
WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K022444(TRADITIONAL)
ATTN: YUE WAH CHOW PHONE NO : 603 870 61486
LOT 1, JALAN 3, SE DECISION MADE: 17-SEP-02
KAWASAN PERUSAHAAN BANDAR BARU 510(k) SUMMARY AVAILABLE FROM FDA
SALAK TINGGI, SEPANG SELANGOR, MALAYSIA 43900
DEVICE: ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM
ZIMMER, INC. 510(k) NO: K021891(TRADITIONAL)
ATTN: FRED MCCLURE PHONE NO : 574-372-4944
P.O. BOX 708 SE DECISION MADE: 05-SEP-02
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 285
TOTAL WITH SUMMARIES 218
TOTAL WITH STATEMENTS 67
Updated 10/07/2002
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