FDA
Home Page | CDRH Home Page | Search
| CDRH
A-Z Index | Contact CDRH
|
| FDA
Home Page | CDRH Home Page | Search
| CDRH
A-Z Index | Contact CDRH
|
510(k)s Final Decisions Rendered for October 1999 |
 |
DEVICE: 3M CLINPRO SEALANT
3M CO. 510(k) NO: K992326(TRADITIONAL)
ATTN: LAEL J PICKETT PHONE NO : 651-733-3594
3M CENTER, BLDG. 260-2B-12 SE DECISION MADE: 08-OCT-99
ST. PAUL, MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PICCOLO SODIUM TEST SYSTEM
ABAXIS INC. 510(k) NO: K993211(TRADITIONAL)
ATTN: LISA MCGRATH PHONE NO : 408-745-6550
1320 CHESAPEAKE TERR. SE DECISION MADE: 25-OCT-99
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABBOTT AXSYM HOMOCYSTEINE
ABBOTT LABORATORIES, INC. 510(k) NO: K992858(TRADITIONAL)
ATTN: MARGARET PROCHNIAK PHONE NO : 847-937-4106
DEPT 9YC, BIDG. AP31 SE DECISION MADE: 25-OCT-99
200 ABBOTT PARK ROAD 510(k) SUMMARY AVAILABLE FROM FDA
ABBOTT PARK, IL 60064-6200
DEVICE: ALCYON 300I (WITH ISE MODULE) ANALYZER
ABBOTT LABORATORIES, INC. 510(k) NO: K993083(SPECIAL)
ATTN: MARK LITTLEFIELD PHONE NO : 972-518-6062
1920 HURD SE DECISION MADE: 05-OCT-99
IRVING, TX 75062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABX PENTRA 60 HEMATOLOGY ANALYZER
ABX DIAGNOSTICS, INC. 510(k) NO: K992511(TRADITIONAL)
ATTN: PAT AMTOWER PHONE NO : 949-453-0500
34 BUNSEN DR. SE DECISION MADE: 15-OCT-99
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076
ACCUTRON, INC. 510(k) NO: K992421(SPECIAL)
ATTN: DOTTIE KNECHTEL PHONE NO : 602-780-2020
2020 WEST MELINDA LANE SE DECISION MADE: 27-OCT-99
PHOENIX, AZ 85027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON COMBO PREGNANCY
ACON LABORATORIES, INC. 510(k) NO: K993065(TRADITIONAL)
ATTN: JIXUN LIN PHONE NO : 858-535-2035
11175 FLINTKOTE AVE., #F & G SE DECISION MADE: 08-OCT-99
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FETAL ASSESSMENT CAP
ACUSON CORP. 510(k) NO: K992580(TRADITIONAL)
ATTN: WILLIAM E WELCH PHONE NO : 004 989 32475830
1220 CHARLESTON RD. SE DECISION MADE: 18-OCT-99
MOUNTAIN VIEW, CA 94039-7393 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOSPECT PLUS WITH INSTILL MOTION CORRECTION
ADAC LABORATORIES 510(k) NO: K992317(TRADITIONAL)
ATTN: DENNIS W HENKELMAN PHONE NO : 408-468-3989
540 ALDER DR. SE DECISION MADE: 01-OCT-99
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE
ADVANCED CARDIOVASCULAR SYSTEMS, I510(k) NO: K992169(TRADITIONAL)
ATTN: MARGARET ANDERSON PHONE NO : 408-235-3995
3200 LAKESIDE DRIVE SE DECISION MADE: 28-OCT-99
SANTA CLARA, CA 95052-8167 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALPHA INFUSION PUMP
ADVANCED INFUSION, INC. 510(k) NO: K992551(TRADITIONAL)
ATTN: JAMES CHRISTENSEN PHONE NO : 480-557-7337
6200 SOUTH MCCLINTOCK #6 SE DECISION MADE: 27-OCT-99
TEMPE, AZ 85283 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CIDEX OPA SOLUTION
ADVANCED STERILIZATION PRODUCTS 510(k) NO: K991487(TRADITIONAL)
ATTN: JOHN E FRIND PHONE NO : 949-789-3885
33 TECHNOLOGY DRIVE SE DECISION MADE: 08-OCT-99
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MCL 29 DERMABLATE ER:YAG LASER SYSTEM
AESCULAP-MEDITEC NORTH AMERICA 510(k) NO: K992707(TRADITIONAL)
ATTN: WILLIAM KELLEY PHONE NO : 949-660-2950
2525 MCGAW AVE. SE DECISION MADE: 19-OCT-99
IRVINE, CA 92623-9791 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCAT
ALBA CRITICAL CARE LTD 510(k) NO: K993245(SPECIAL)
ATTN: TED VANDER WIEDE PHONE NO : 169 874 6699
PHOENIX CRESCENT SE DECISION MADE: 28-OCT-99
STRATHCLYDE BUSINESS PARK 510(k) SUMMARY AVAILABLE FROM FDA
BELLSHILL, UNITED KINGDOM ML4 3NJ
DEVICE: BROWNE CIDEX OPA INDICATOR
ALBERT BROWNE LTD. 510(k) NO: K991709(TRADITIONAL)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 919-859-4207
49 PLAIN STREET SE DECISION MADE: 08-OCT-99
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRADERM STERILE LATEX POWDERED SURGICAL SLOVES WITH PROTEIN CO
ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K991205(TRADITIONAL)
ATTN: ERICA SETHI PHONE NO : 847-785-3337
1500 WAUKEGAN RD. SE DECISION MADE: 13-OCT-99
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REFRESH CONTACTS LUBRICATING AND REWETTING DROPS
ALLERGAN, INC. 510(k) NO: K992028(ABBREVIATED)
ATTN: PAUL J NOWACKI PHONE NO : 714-246-6761
2525 DUPONT DR. SE DECISION MADE: 07-OCT-99
IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES LABELING CON
ALLIANCE RUBBER PRODUCTS SDN. BHD.510(k) NO: K992870(TRADITIONAL)
ATTN: CHUA HOOI KOON PHONE NO : 600 459 32235
LOT 2716&2720, MK 7, KAWASAN SE DECISION MADE: 15-OCT-99
PERINDUSTRIAN BUKIT PANCHOR 510(k) STATEMENT
NINONG TEBAL, PULAU PINANG, MALAYSIA 14300
DEVICE: AMBU HAND POWER SUCTION PUMP
AMBU, INC. 510(k) NO: K992902(TRADITIONAL)
ATTN: SANJAY PARIKH PHONE NO : 410-636-1144
611 NORTH HAMMONDS FERRY RD. SE DECISION MADE: 25-OCT-99
LINTHICUM, MD 21090-1356 510(k) STATEMENT
DEVICE: RAPIDONE-AMPHETAMINE TEST
AMERICAN BIO MEDICA CORP. 510(k) NO: K992452(TRADITIONAL)
ATTN: JOHN B DUBECK PHONE NO : 202-434-4125
1001 G STREET, NW SE DECISION MADE: 18-OCT-99
SUITE 500W 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20001
DEVICE: AMIGO MODEL 680000 (AMIGO EXCITE F 350)
AMIGO MOBILITY INTL., INC. 510(k) NO: K992619(TRADITIONAL)
ATTN: DALE CONFER PHONE NO : 517-777-0910
6693 DIXIE HWY. SE DECISION MADE: 25-OCT-99
BRIDGEPORT, MI 48722 510(k) STATEMENT
DEVICE: 50 W METAL HALIDE ILLUMINATOR, VES 0501.
ANGIOLAZ, INC. 510(k) NO: K992447(TRADITIONAL)
ATTN: JOHN PLUMADORE PHONE NO : 802-463-9976
INDUSTRIAL PARK SE DECISION MADE: 20-OCT-99
BELLOWS FALLS, VT 05101-0556 510(k) STATEMENT
DEVICE: SYNSATION STERILE POWDER FREE, POLYVINYL CHLORIDE MEDICAL EXAMIN
ANSELL PERRY INC. 510(k) NO: K992156(TRADITIONAL)
ATTN: JAMES R CHATTERTON PHONE NO : 330-833-2811
1875 HARSH AVENUE, S.E. SE DECISION MADE: 27-OCT-99
MASSILLON, OH 44646-7199 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NITRA-TOUCH STERILE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOV
ANSELL PERRY INC. 510(k) NO: K992768(TRADITIONAL)
ATTN: JAMES R CHATTERTON PHONE NO : 330-833-2811
1875 HARSH AVENUE, S.E. SE DECISION MADE: 13-OCT-99
MASSILLON, OH 44646-7199 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGEONS GLOVE, BROWN LATEX POLYMER COATED, POWDER FREE WITH PRO
ANSELL PERRY INC. 510(k) NO: K992953(TRADITIONAL)
ATTN: JAMES R CHATTERTON PHONE NO : 330-833-2811
1875 HARSH AVENUE, S.E. SE DECISION MADE: 29-OCT-99
MASSILLON, OH 44646-7199 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANTA GRAFT (<6MM)
ATRIUM MEDICAL CORP. 510(k) NO: K992958(SPECIAL)
ATTN: KAREN HALL PHONE NO : 603-880-1433
5 WENTWORTH DR. SE DECISION MADE: 01-OCT-99
HUDSON, NH 03051 510(k) STATEMENT
DEVICE: ADVANTA GRAFT (>6MM)
ATRIUM MEDICAL CORP. 510(k) NO: K992960(SPECIAL)
ATTN: KAREN HALL PHONE NO : 603-880-1433
5 WENTWORTH DR. SE DECISION MADE: 01-OCT-99
HUDSON, NH 03051 510(k) STATEMENT
DEVICE: NEO-2 METER
AUTOMATA INSTRUMENTATION, INC. 510(k) NO: K992431(TRADITIONAL)
ATTN: LINDA V MASANO PHONE NO : 480-998-8422
15600 NORTH 78TH ST. SE DECISION MADE: 13-OCT-99
SCOTTSDALE, AZ 85260-1735 510(k) STATEMENT
DEVICE: MODIFICATION TO IMX HOMOCYSTEINE
AXIS BIOCHEMICALS, ASA 510(k) NO: K992274(TRADITIONAL)
ATTN: RONALD G LEONARDI PHONE NO : 619-586-0751
PO BOX 262069 SE DECISION MADE: 06-OCT-99
SAN DIEGO, CA 92196 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER
AZO ENTERPRISES 510(k) NO: K992435(TRADITIONAL)
ATTN: NABIL AZO PHONE NO :
6114 NORTH SACRAMENTO SE DECISION MADE: 15-OCT-99
CHICAGO, IL 60659 510(k) STATEMENT
DEVICE: BALLARD MIC-KEY "G" LOW PROFILE GASTROSTOMY REPLACEMENT KIT
BALLARD MEDICAL PRODUCTS 510(k) NO: K993138(SPECIAL)
ATTN: E. MARTIN CHAMBERLAIN PHONE NO : 801-572-6800
12050 S. LONE PEAK PKWY. SE DECISION MADE: 20-OCT-99
DRAPER, UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 0.9% SODIUM CHLORIDE FLUSH SYRINGE
BAXTER HEALTHCARE CORP. 510(k) NO: K984590(TRADITIONAL)
ATTN: MARCIA MARCONI PHONE NO : 847-270-4637
CLINTEC NUTRITION CO. SE DECISION MADE: 07-OCT-99
ROUTE 120 AND WILSON ROAD 510(k) SUMMARY AVAILABLE FROM FDA
ROUND LAKE, IL 60073
DEVICE: T-ANASTAFLO
BAXTER RESEARCH MEDICAL, INC. 510(k) NO: K990396(TRADITIONAL)
ATTN: JOHN W SMITH PHONE NO : 801-565-6213
6864 SOUTH 300 WEST SE DECISION MADE: 01-OCT-99
MIDVALE, UT 84047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BECTON DICKINSON SYRINGE
BECTON DICKINSON & CO. 510(k) NO: K992734(TRADITIONAL)
ATTN: GREG MORGAN PHONE NO : 201-847-4344
1 BECTON DRIVE, BLDG 2, SE DECISION MADE: 01-OCT-99
MAIL CODE 226 510(k) SUMMARY AVAILABLE FROM FDA
FRANKLIN LAKES, NJ 07417
DEVICE: EXTREME H20 (HIOXIFILICON A) SOFT CONTACT LENS
BENZ RESEARCH AND DEVELOPMENT CORP510(k) NO: K992692(TRADITIONAL)
ATTN: JOSE A ORS PHONE NO : 941-758-8256
P.O. BOX 1839 SE DECISION MADE: 18-OCT-99
SARASOTA, FL 34230-1839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASCENT KNEE SYSTEM
BIOMET MANUFACTURING, INC. 510(k) NO: K993111(SPECIAL)
ATTN: MARY VERSTYNEN PHONE NO : 219-267-6639
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 05-OCT-99
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: BIO-MODULAR SHOULDER OFFSET HUMERAL HEADS
BIOMET, INC. 510(k) NO: K992899(TRADITIONAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 219-267-6639
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 21-OCT-99
WARSAW, IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO BONE MULCH SCREW SYSTEM
BIOMET, INC. 510(k) NO: K993025(SPECIAL)
ATTN: FRED MCCLURE PHONE NO : 210-372-1568
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 08-OCT-99
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: MAXIM KNEE SYSTEM
BIOMET, INC. 510(k) NO: K993159(SPECIAL)
ATTN: TRACY J BICKEL PHONE NO : 219-372-1761
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 14-OCT-99
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: SEALOUETTE FIBRIN SEALANT APPLICATOR
BIOSURGICAL CORP. 510(k) NO: K992351(TRADITIONAL)
ATTN: TERRY E LAAS PHONE NO : 925-737-1850
5990 STONERIDGE AVE SE DECISION MADE: 08-OCT-99
SUITE 112 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANTON, CA 94588
DEVICE: ILLUSION
BISCO, INC. 510(k) NO: K993192(TRADITIONAL)
ATTN: KATHEYN B PATTERSON PHONE NO : 847-534-6146
1100 WEST IRVING PARK RD. SE DECISION MADE: 27-OCT-99
SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRODUCER SHEATH, VESSEL DILATOR
BOSTON SCIENTIFIC CORP. 510(k) NO: K992309(TRADITIONAL)
ATTN: SUSAN POOL PHONE NO : 408-895-3608
2710 ORCHARD PARKWAY SE DECISION MADE: 07-OCT-99
SAN JOSE, CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO LINER II: SOFT RELINE LIQUID
BOSWORTH CO. 510(k) NO: K991687(TRADITIONAL)
ATTN: MILDRED M GOLDSTEIN PHONE NO : 708-679-3400
7227 NORTH HAMLIN AVENUE SE DECISION MADE: 07-OCT-99
SKOKIE, IL 60076-3999 510(k) STATEMENT
DEVICE: BRAUN THERMOSCAN PRO3000 INFARED THERMOMETER
BRAUN GMBH 510(k) NO: K992468(TRADITIONAL)
ATTN: LAURA GUY PHONE NO : 858-458-2290
10421 PACIFIC CENTER COURT SE DECISION MADE: 20-OCT-99
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE BRIGHT MEDICAL DILATION RETRACTOR SYSTEM
BRIGHT MEDICAL INSTRUMENTS 510(k) NO: K992898(TRADITIONAL)
ATTN: ROBERT E SIMONSON PHONE NO : 877-527-4448
799 N.E. 71ST STREET SE DECISION MADE: 21-OCT-99
BOCA RATON, FL 33487 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIDEO PLUS SYSTEM, SERIES 95000
CAMTRONICS, LTD. 510(k) NO: K992666(TRADITIONAL)
ATTN: ROBERT KRIEDERMANN PHONE NO : 414-367-0700
MEDICAL SYSTEMS SE DECISION MADE: 13-OCT-99
900 WALNUT RIDGE DR. 510(k) SUMMARY AVAILABLE FROM FDA
HARTLAND, WI 53029
DEVICE: CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22
CANON U.S.A. INC. 510(k) NO: K992547(TRADITIONAL)
ATTN: KEN SHADOFF PHONE NO : 516-328-5602
ONE CANON PLAZA SE DECISION MADE: 13-OCT-99
LAKE SUCCESS, NY 11042-1113 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECG MINIMONITOR, MODEL CG-5000
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K992696(TRADITIONAL)
ATTN: LEONID TRACHTENBERG PHONE NO : 972 894 84600
2 PERERIS ST., SCIENCE PARK SE DECISION MADE: 07-OCT-99
REHOVOT, ISRAEL 76100 510(k) STATEMENT
DEVICE: CATHETER INNOVATIONS IMPLANTABLE PORT
CATHETER INNOVATIONS, INC. 510(k) NO: K991897(TRADITIONAL)
ATTN: ROGER L RICHINS PHONE NO : 801-954-8444
3598 WEST 1820 SOUTH SE DECISION MADE: 21-OCT-99
SALT LAKE CITY, UT 84104-4859 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D/SENSE II (GREEN-OR) DENTIN DESENSITIZER
CENTRIX INC. 510(k) NO: K992629(TRADITIONAL)
ATTN: JOHN DISCKO PHONE NO : 203-929-5582
770 RIVER ROAD SE DECISION MADE: 22-OCT-99
SHELTON, CT 06484-5458 510(k) STATEMENT
DEVICE: CERALAS D 980NM DIODE LASER SYSTEM, MODEL D15
CERAMOPTEC, INC. 510(k) NO: K993002(TRADITIONAL)
ATTN: CAROL J MORELLO PHONE NO : 413-525-0600
515 SHAKER ROAD SE DECISION MADE: 14-OCT-99
EAST LONGMEADOW, MA 01028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM
CIRCON CORP. 510(k) NO: K992544(TRADITIONAL)
ATTN: RONALD J EHMSEN PHONE NO : 805-961-3290
6500 HOLLISTER AVENUE SE DECISION MADE: 26-OCT-99
SANTA BARBARA, CA 93117-3019 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COBE OPTIMIN HOLLOW FIBER MEMBRANE OXYGENATOR
COBE CARDIOVASCULAR, INC. 510(k) NO: K991452(TRADITIONAL)
ATTN: LYNNE LEONARD PHONE NO : 303-467-6586
14401 WEST 65TH WAY SE DECISION MADE: 07-OCT-99
ARVADA, CO 80004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS
CODMAN & SHURTLEFF, INC. 510(k) NO: K992591(TRADITIONAL)
ATTN: JAMES M FLAHERTY PHONE NO : 508-880-8404
325 PARAMOUNT DRIVE SE DECISION MADE: 15-OCT-99
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TUBULAR ELECTRODE DEVICE
CONWAY STUART MEDICAL, INC. 510(k) NO: K992542(TRADITIONAL)
ATTN: THOMAS WEHMAN PHONE NO : 408-733-9910
735 PALOMAR ST. SE DECISION MADE: 27-OCT-99
SUNNYVALE, CA 94086 510(k) STATEMENT
DEVICE: COOK ULTRA QUIET VACUUM PUMP & REGULATOR
COOK UROLOGICAL, INC. 510(k) NO: K992070(TRADITIONAL)
ATTN: BRENDA DAVIS PHONE NO : 812-829-6500
1100 WEST MORGAN ST. SE DECISION MADE: 27-OCT-99
SPENCER, IN 47460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MAR
CORDIS CORP. 510(k) NO: K992347(TRADITIONAL)
ATTN: KAREN WILK PHONE NO : 908-412-7257
40 TECHNOLOGY DRIVE SE DECISION MADE: 08-OCT-99
WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISTA BRITE TIP CATHETERS
CORDIS CORP. 510(k) NO: K992673(TRADITIONAL)
ATTN: DENNIS S GRIFFIN PHONE NO : 305-824-5283
14201 N.W. 60TH AVE. SE DECISION MADE: 12-OCT-99
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALMAZ XL TANSHEPATIC BILIARY STENTS
CORDIS CORP. 510(k) NO: K993091(SPECIAL)
ATTN: ARIEL MACTAVISH PHONE NO : 305-824-2332
14201 N.W. 60TH AVE. SE DECISION MADE: 29-OCT-99
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROWLER PLUS INFUSION CATHETER
CORDIS ENDOVASCULAR SYSTEMS, INC. 510(k) NO: K993266(SPECIAL)
ATTN: MARITZA CELAYA PHONE NO : 305-512-6546
14000 N.W. 57TH CT. SE DECISION MADE: 28-OCT-99
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078
CORDIS WEBSTER, INC. 510(k) NO: K991531(TRADITIONAL)
ATTN: MARY ADAMS PHONE NO : 626-939-8604
4750 LITTLEJOHN ST. SE DECISION MADE: 04-OCT-99
BALDWIN PARK, CA 91706 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DADE BEHRING N HIGH SENSITIVITY CRP ASSAY
DADE BEHRING, INC. 510(k) NO: K991385(TRADITIONAL)
ATTN: REBECCA S AYASH PHONE NO : 302-631-6276
P.O. BOX 6101 SE DECISION MADE: 25-OCT-99
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DAIWA MODEL 180
DAIWA PRODUCTS, INC. 510(k) NO: K983616(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 410-451-0639
P.O. BOX 4341 SE DECISION MADE: 15-OCT-99
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: HDL-C/LDL-C CALIBRATOR, MODEL 1913-003
DATA MEDICAL ASSOCIATES, INC. 510(k) NO: K993098(TRADITIONAL)
ATTN: THOMAS G DOLLAR PHONE NO : 817-640-0965
845 AVENUE "G" EAST SE DECISION MADE: 08-OCT-99
ARLINGTON, TX 76011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NRC NON-RINSE CONDITIONER
DENTSPLY INTL. 510(k) NO: K992519(TRADITIONAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVE SE DECISION MADE: 22-OCT-99
YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUCITONE FRS FLEXIBEL DENTAL RESIN
DENTSPLY INTL. 510(k) NO: K992956(TRADITIONAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
570 WEST COLLEGE AVE SE DECISION MADE: 06-OCT-99
YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTER
DEROYAL CARDIOVASCULAR, INC. 510(k) NO: K993089(TRADITIONAL)
ATTN: LOIS MARSH PHONE NO : 423-938-7828
200 DEBUSK LANE SE DECISION MADE: 14-OCT-99
POWELL, TN 37849 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50
DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K993178(TRADITIONAL)
ATTN: KAREN CALLBECK PHONE NO : 902 566 1396
16 MCCARVILLE STREET SE DECISION MADE: 18-OCT-99
WEST ROYALTY INDUSTRIAL PARK 510(k) STATEMENT
CHARLOTTETOWN, P.E.I., CANADA C1E 2A6
DEVICE: DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM
DIAMEDIX CORP. 510(k) NO: K993294(TRADITIONAL)
ATTN: LYNNE STIRLING, PH.D PHONE NO : 305-324-2354
2140 NORTH MIAMI AVE. SE DECISION MADE: 25-OCT-99
MIAMI, FL 33127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHELLY PROTECTED AV FISTULA NEEDLE
DIASOL INC. 510(k) NO: K992653(TRADITIONAL)
ATTN: MONICA ABELES PHONE NO : 818-255-1800
13212 RAYMER ST. SE DECISION MADE: 27-OCT-99
NORTH HOLLYWOOD, CA 91605 510(k) STATEMENT
DEVICE: DRYASOL ACID CONCENTRATE MIX
DIASOL INC. 510(k) NO: K993212(SPECIAL)
ATTN: MONICA ABELES PHONE NO : 818-255-1800
13212 RAYMER ST. SE DECISION MADE: 22-OCT-99
NORTH HOLLYWOOD, CA 91605 510(k) STATEMENT
DEVICE: HYBRID CAPTURE II CT-ID TEST
DIGENE CORP. 510(k) NO: K990023(TRADITIONAL)
ATTN: MARK DEL VECCHIO PHONE NO : 301-470-6500
9000 VIRGINIA MANOR RD., SE DECISION MADE: 25-OCT-99
BELTSVILLE, MD 20705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODULAR INSTRUMENT SYSTEM FOR MINIMAL INVASIVE SURGERY
DR. FRITZ GMBH 510(k) NO: K990372(TRADITIONAL)
ATTN: JAMES CHITTY PHONE NO : 310-263-4150
13311 BROOKS DRIVE, SUITE E SE DECISION MADE: 14-OCT-99
BALDWIN PARK, CA 91706 510(k) STATEMENT
DEVICE: HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRA
ELAN HOLDINGS, INC. 510(k) NO: K992845(TRADITIONAL)
ATTN: WYNN STOCKING PHONE NO : 714-871-8360
231 NORTH PUENTE ST. SE DECISION MADE: 18-OCT-99
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HICHEM TOTAL PROTEIN REAGENT
ELAN HOLDINGS, INC. 510(k) NO: K992846(TRADITIONAL)
ATTN: WYNN STOCKING PHONE NO : 714-871-8360
231 NORTH PUENTE ST. SE DECISION MADE: 18-OCT-99
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HICHEM BUN REAGENT
ELAN HOLDINGS, INC. 510(k) NO: K992847(TRADITIONAL)
ATTN: WYNN STOCKING PHONE NO : 714-871-8360
231 NORTH PUENTE ST. SE DECISION MADE: 14-OCT-99
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTRIC MOBILITY "CAVALIER SCOOTERS"
ELECTRIC MOBILITY CORP. 510(k) NO: K991281(TRADITIONAL)
ATTN: MARK HOSKIN PHONE NO : 609-468-0270
1 MOBILITY PLAZA SE DECISION MADE: 27-OCT-99
SEWELL, NJ 08080 510(k) STATEMENT
DEVICE: AIRFLOW HANDY
ELECTRO MEDICAL SYSTEMS, INC. 510(k) NO: K991857(TRADITIONAL)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 07-OCT-99
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI OMEGA 21 SYSTEM
ELECTRO-BIOLOGY, INC. 510(k) NO: K992333(TRADITIONAL)
ATTN: JONAS WILF PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 08-OCT-99
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGITRON RADIOLASE
ELLMAN INTL., INC. 510(k) NO: K992382(TRADITIONAL)
ATTN: FRANK LIN PHONE NO : 516-569-1482
1135 RAILROAD AVE., SE DECISION MADE: 14-OCT-99
ELLMAN BLDG. 510(k) SUMMARY AVAILABLE FROM FDA
HEWLETT, NY 11557
DEVICE: EMORY CARDIAC TOOLBOX* 2.0 EXECUTING ON NUCLEAR MEDICINE COMPUTE
EMORY UNIVERSITY 510(k) NO: K992450(TRADITIONAL)
ATTN: ERNEST V GARCIA PHONE NO : 404-712-7422
1364 CLIFTON RD. N.E. SE DECISION MADE: 07-OCT-99
RM. E163 510(k) SUMMARY AVAILABLE FROM FDA
ATLANTA, GA 30322
DEVICE: DUAL LUMEN CATHETER, MODEL DL-35-90
ENDOLOGIX, INC. 510(k) NO: K991601(TRADITIONAL)
ATTN: KAREN U SALINAS PHONE NO : 949-830-9433
20 FAIRBANKS, SUITE #173 SE DECISION MADE: 28-OCT-99
IRVINE, CA 92618 510(k) STATEMENT
DEVICE: BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT
ENDOTEC, INC. 510(k) NO: K992394(TRADITIONAL)
ATTN: JOHN PAPPAS PHONE NO : 973-762-0095
20 VALLEY STREET SE DECISION MADE: 15-OCT-99
SOUTH ORANGE, NJ 07079 510(k) STATEMENT
DEVICE: ERBE APC RASPATORY HANDLE AND TIP, MODEL 20132-102, 20132-103
ERBE USA, INC. 510(k) NO: K992764(TRADITIONAL)
ATTN: SCOTT CUNDY PHONE NO : 770-955-4400
2225 NORTHWEST PKWY., STE. 105 SE DECISION MADE: 14-OCT-99
MARIETTA, GA 30067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ERBE APC APPLICATORS, MODELS 20132-106, 20132-107, 20132-109, 20
ERBE USA, INC. 510(k) NO: K992769(TRADITIONAL)
ATTN: SCOTT CUNDY PHONE NO : 770-955-4400
2225 NORTHWEST PKWY., STE. 105 SE DECISION MADE: 14-OCT-99
MARIETTA, GA 30067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OXYCONALPHA WITH OPTION ECG
ERICH JAEGER B.V. 510(k) NO: K984465(TRADITIONAL)
ATTN: LEON DEN BAKKER PHONE NO : 030-659-4600
REGULIERENING 11 SE DECISION MADE: 27-OCT-99
NL-3981 LA BUNNIK, NETHERLANDS NL-510(k) STATEMENT
DEVICE: REFERENCE
ESPE DENTAL AG 510(k) NO: K992966(TRADITIONAL)
ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395
ESPE PLATZ SE DECISION MADE: 07-OCT-99
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM WITH COATED VICRYL,
ETHICON ENDO-SURGERY, INC. 510(k) NO: K992612(TRADITIONAL)
ATTN: EDWIN O BILLIPS PHONE NO : 513-786-7162
4545 CREEK RD. SE DECISION MADE: 14-OCT-99
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: URETERO-RENOSCOPE
FIBER IMAGING TECHNOLOGIES, INC. 510(k) NO: K992527(TRADITIONAL)
ATTN: JOSEPH RESS PHONE NO : 617-965-7714
45 PONTIAC ROAD SE DECISION MADE: 13-OCT-99
NEWTON, MA 02468 510(k) STATEMENT
DEVICE: FUKUDA DENSHI FF SONIC UF-5800 GENERAL PURPOSE ULTRASOUND SCANNI
FUKUDA DENSHI USA, INC. 510(k) NO: K990401(TRADITIONAL)
ATTN: DAVID J GERAGHTY PHONE NO : 425-881-7737
55 NORTHERN BLVD., SUITE 410 SE DECISION MADE: 15-OCT-99
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
GAMBRO RENAL CARE PRODUCTS 510(k) NO: K993064(SPECIAL)
ATTN: WILLIAM M TOWNSEND PHONE NO : 303-231-4730
1185 OAK ST. SE DECISION MADE: 06-OCT-99
LAKEWOOD, CO 80215-4498 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CASE 8000 EXERCISE TESTING SYSTEM
GE MARQUETTE MEDICAL SYSTEMS, INC.510(k) NO: K991014(TRADITIONAL)
ATTN: LAURA L MCCOMIS PHONE NO : 414-362-2688
8200 WEST TOWER AVE. SE DECISION MADE: 20-OCT-99
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILHOUETTE FC
GE MEDICAL SYSTEMS, INC. 510(k) NO: K993090(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 414-544-3894
3000 N. GRANDVIEW BLVD. SE DECISION MADE: 01-OCT-99
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANEROID SPHYGMOMANOMETER
GENMED, INC. 510(k) NO: K990638(ABBREVIATED)
ATTN: EDWARD HYER PHONE NO : 410-354-3300
914 WEST PATAPSCO AVE. SE DECISION MADE: 07-OCT-99
BALTIMORE, MD 21230-3432 510(k) STATEMENT
DEVICE: N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTER
GENZYME CORP. 510(k) NO: K992766(TRADITIONAL)
ATTN: BARBARA PIZZA PHONE NO : 617-252-7953
ONE KENDALL SQUARE SE DECISION MADE: 18-OCT-99
CAMBRIDGE, MA 02139-1562 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENZYME DIRECT AMYLASE VERIFIER
GENZYME CORP. 510(k) NO: K993132(ABBREVIATED)
ATTN: BARBARA PIZZA PHONE NO : 617-252-7953
ONE KENDALL SQUARE SE DECISION MADE: 04-OCT-99
CAMBRIDGE, MA 02139-1562 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECOMED SCALP VEIN SET
GREINER MEDITECH, INC. 510(k) NO: K992145(TRADITIONAL)
ATTN: DOUGLAS L HARRIS PHONE NO : 410-836-8228
260 GATEWAY DR., SUITE 17A SE DECISION MADE: 14-OCT-99
BEL AIR, MD 21014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RX MEGALINK SDS BILIARY STENT SYSTEM, OTW MEGALINK SDS BILIARY S
GUIDANT CORP. 510(k) NO: K992319(TRADITIONAL)
ATTN: SANDRA SUNDELL PHONE NO : 408-845-4278
3200 LAKESIDE DRIVE SE DECISION MADE: 08-OCT-99
P.O. BOX 58167 510(k) SUMMARY AVAILABLE FROM FDA
SANTA CLARA, CA 95052-8167
DEVICE: RESPALERT
HARWILL MEDICAL (PTY) LTD. 510(k) NO: K992618(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 410-451-0639
P O BOX 4341 SE DECISION MADE: 29-OCT-99
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: REP CHOLESTEROL PROFILE KIT
HELENA LABORATORIES 510(k) NO: K992971(TRADITIONAL)
ATTN: ERIC PETERSON PHONE NO : 800-231-5663
1530 LINDBERGH DR. SE DECISION MADE: 18-OCT-99
BEAUMONT, TX 77704 510(k) STATEMENT
DEVICE: CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELE
HENKE SASS WOLF OF AMERICA, INC. 510(k) NO: K991563(TRADITIONAL)
ATTN: ELLEN HENKE PHONE NO : 781-934-9498
73 EAGLES NEST ROAD SE DECISION MADE: 13-OCT-99
DUXBURY, MA 02332 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLUMA COMFORT BOND + DESENSITIZER
HERAEUS KULZER, INC. 510(k) NO: K992292(TRADITIONAL)
ATTN: CHERYL V ZIMMERMAN PHONE NO : 219-299-6662
4315 S.LAFAYETTE SE DECISION MADE: 01-OCT-99
SOUTH BEND, IN 46614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLUMA COMFORT BOND
HERAEUS KULZER, INC. 510(k) NO: K992985(TRADITIONAL)
ATTN: CHERYL V ZIMMERMAN PHONE NO : 219-291-0661
4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 14-OCT-99
SOUTH BEND, IN 46614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3
HEWLETT-PACKARD CO. 510(k) NO: K993171(SPECIAL)
ATTN: DAVE OSBORN PHONE NO : 978-659-3173
3000 MINUTEMAN ROAD SE DECISION MADE: 21-OCT-99
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A
HEWLETT-PACKARD, HEALTHCARE SOLUTI510(k) NO: K992478(TRADITIONAL)
ATTN: SHEILA W PICKERING PHONE NO : 650-969-6114
2081 LONGDEN CIRCLE SE DECISION MADE: 15-OCT-99
LOS ALTOS, CA 94024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIRIS, AIRIS II
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K992650(TRADITIONAL)
ATTN: JAMES JOCHEN ROGERS PHONE NO : 330-425-1313
1959 SUMMIT COMMERCE PARK SE DECISION MADE: 08-OCT-99
TWINSBURG, OH 44087-2371 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMPLICARE TRANSPARENT WOUND DRESSING
HOLLISTER, INC. 510(k) NO: K991214(TRADITIONAL)
ATTN: JOSEPH S TOKARZ PHONE NO : 847-680-2849
2000 HOLLISTER DR. SE DECISION MADE: 14-OCT-99
LIBERTYVILLE, IL 60048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, Q
HOLOGIC, INC. 510(k) NO: K992775(TRADITIONAL)
ATTN: NANDINI MURTHY PHONE NO : 781-999-7300
35 CROSBY DR. SE DECISION MADE: 01-OCT-99
BEDFORD, MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTIVA
HOVEROUND CORP. 510(k) NO: K991132(TRADITIONAL)
ATTN: STAN COOPER PHONE NO : 800-964-6837
2151 WHITFIELD INDUSTRIAL WAY SE DECISION MADE: 20-OCT-99
SARASOTA, FL 34243 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALTA FULLY THREADED CROSS-LOCKING 5.0 MM SCREW
HOWMEDICA OSTEONICS CORP. 510(k) NO: K993004(SPECIAL)
ATTN: JENNIFER A DAUDELIN PHONE NO : 201-507-7283
359 VETERANS BLVD. SE DECISION MADE: 06-OCT-99
RUTHERFORD, NJ 07070-2584 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOWMEDICA OSTEONICS RESTORATION HA HIP STEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K993077(SPECIAL)
ATTN: MARY-CATHERINE DILLON PHONE NO : 201-760-8117
59 ROUTE 17 SE DECISION MADE: 08-OCT-99
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOWMEDICA OSTEONICS ACCP SYSTEM CORTICAL SCREWS
HOWMEDICA OSTEONICS CORP. 510(k) NO: K993181(SPECIAL)
ATTN: MARY-CATHERINE DILLON PHONE NO : 201-760-8117
59 ROUTE 17 SE DECISION MADE: 22-OCT-99
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYDROCISION ARTHROJET SYSTEM WITH CAUTERY
HYDROCISION, INC. 510(k) NO: K993009(TRADITIONAL)
ATTN: DEBBIE IAMPIETRO PHONE NO : 978-657-0020
220 BALLARDVALE STREET SE DECISION MADE: 25-OCT-99
WILMINGTON, MA 01887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HTU3
HYOX SYSTEMS LTD. 510(k) NO: K984313(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813
555 THIRTEENTH STREET, NW SE DECISION MADE: 22-OCT-99
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROGRASP MONOPOLAR COAGULATOR, MODEL NOS 90001-90010
HYSTERX, INC. 510(k) NO: K992714(TRADITIONAL)
ATTN: JUDY F GORDON PHONE NO : 949-854-6314
18732 SAGINAW SE DECISION MADE: 05-OCT-99
IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRAOP CATHETER
I-FLOW CORP. 510(k) NO: K991543(TRADITIONAL)
ATTN: STANLEY E FRY PHONE NO : 949-206-2700
20202 WINDROW DR. SE DECISION MADE: 25-OCT-99
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERACOUSTICS EP 15 ABR STAND ALONE UNIT
IDEM (INT'L DIST. OF ELECTRONICS F510(k) NO: K991853(TRADITIONAL)
ATTN: DONNA WARD PHONE NO : 800-947-6334
4814 EAST SECOND ST. SE DECISION MADE: 25-OCT-99
BENICIA, CA 94510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000
IMAGE-GUIDED NEUROLOGICS, INC. 510(k) NO: K992796(TRADITIONAL)
ATTN: MICHAEL RENNER PHONE NO : 407-757-2290
2290 EAU GALLIE BLVD. SE DECISION MADE: 25-OCT-99
MELBOURNE, FL 32935 510(k) STATEMENT
DEVICE: ANTI-TISSUE TRANSGLUTAMINASE (TTG)ANTIBODY TEST
IMMCO DIAGNOSTICS, INC. 510(k) NO: K992878(TRADITIONAL)
ATTN: KEVIN LAWSON PHONE NO : 716-691-0091
60 PINEVIEW DR. SE DECISION MADE: 15-OCT-99
BUFFALO, NY 14228 510(k) STATEMENT
DEVICE: ENDOSSEOUS IMPLANTS AND ABUTMENTS- TIN COATING
IMPLANT INNOVATIONS, INC. 510(k) NO: K992334(TRADITIONAL)
ATTN: WILLIAM G CONETY PHONE NO : 800-443-8166
4555 RIVERSIDE DR. SE DECISION MADE: 08-OCT-99
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2Y
IMPLEX CORP. 510(k) NO: K992409(TRADITIONAL)
ATTN: JOHN SCHLAGO PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 08-OCT-99
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSURE PRO TEST
INBIOS INTL., INC. 510(k) NO: K992695(TRADITIONAL)
ATTN: ESTELA RAYCHAUDHURI PHONE NO : 206-344-5821
562 1ST. AVE. SOUTH, SUITE 703 SE DECISION MADE: 18-OCT-99
SEATTLE, WA 98104 510(k) STATEMENT
DEVICE: INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM
INDIGO MEDICAL, INC. 510(k) NO: K992262(TRADITIONAL)
ATTN: JACQUELYN A HUGHES PHONE NO : 513-786-7987
10123 ALLIANCE RD. SE DECISION MADE: 04-OCT-99
CINCINNATI, OH 45242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTITRAC
INDIVIDUAL MONITORING SYSTEMS, INC510(k) NO: K992410(TRADITIONAL)
ATTN: DAVID T KRAUSMAN PHONE NO : 410-296-7723
1055 TAYLOR AVE., SUITE 300 SE DECISION MADE: 15-OCT-99
BALTIMORE, MD 21286-8334 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000
INFIMED, INC. 510(k) NO: K992575(TRADITIONAL)
ATTN: RALPH J FLATAU PHONE NO : 315-453-4545
121 METROPOLITAN DR. SE DECISION MADE: 07-OCT-99
LIVERPOOL, NY 13088 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RC TACK
INNOVASIVE DEVICES, INC. 510(k) NO: K992377(TRADITIONAL)
ATTN: KATHLEEN MORAHAN PHONE NO : 508-460-8229
734 FOREST ST. SE DECISION MADE: 08-OCT-99
MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RC MULTISUTURE BONE ANCHOR, MODEL 4453/4454
INNOVASIVE DEVICES, INC. 510(k) NO: K992458(TRADITIONAL)
ATTN: KATHLEEN MORAHAN PHONE NO : 580-460-8229
734 FOREST ST. SE DECISION MADE: 14-OCT-99
MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAHO AUTOCLAVABLE CYSTOSCOPE
INNOVATIVE ENDOSCOPY COMPONENTS, L510(k) NO: K992983(TRADITIONAL)
ATTN: GERALD GOIGITZER PHONE NO : 954-217-8780
1112 WESTON RD., SUITE 227 SE DECISION MADE: 07-OCT-99
FT. LAUDERDALE, FL 33326 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNERGY INTEGRAL SCREWS, MODELS, 2161,2162,2163,2164,2165,2166,2
INTERPORE CROSS INTL. 510(k) NO: K992369(TRADITIONAL)
ATTN: LYNN M RODARTI PHONE NO : 949-453-3200
181 TECHNOLOGY DR. SE DECISION MADE: 13-OCT-99
IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO INTRASTENT
INTRATHERAPEUTICS, INC. 510(k) NO: K992816(SPECIAL)
ATTN: CATHY YOHNK PHONE NO : 612-697-2003
651 CAMPUS DR. SE DECISION MADE: 15-OCT-99
ST. PAUL, MN 55112-3495 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENTURE IHO 100 HOME FILL COMPLETE HOME OXYGEN SYSTEM
INVACARE CORP. 510(k) NO: K983627(TRADITIONAL)
ATTN: EDWARD A KROLL PHONE NO : 440-329-6595
P.O. BOX 4028 SE DECISION MADE: 22-OCT-99
ELYRIA, OH 44036-2125 510(k) STATEMENT
DEVICE: MODEL IRC 1001 AEROSOL COMPRESSOR
INVACARE CORP. 510(k) NO: K992643(TRADITIONAL)
ATTN: EDWARD A KROLL PHONE NO : 440-329-6000
ONE INVACARE WAY SE DECISION MADE: 27-OCT-99
ELYRIA, OH 44035-2125 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUMA-CATH FIXED CURVE EP CATHETERS
IRVINE BIOMEDICAL, INC. 510(k) NO: K991025(SPECIAL)
ATTN: ROGER TU PHONE NO : 949-851-3053
2146-A MICHELSON DR. SE DECISION MADE: 15-OCT-99
IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIO 300
ITO CO., LTD. 510(k) NO: K990787(TRADITIONAL)
ATTN: T. WHIT ATHEY PHONE NO : 301-770-9590
2300 TWINBROOK PARKWAY, SE DECISION MADE: 20-OCT-99
SUITE 625 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20852
DEVICE: ATD AUTOMATIC BRIDGE REMOVER
J. MORITA USA, INC. 510(k) NO: K992649(TRADITIONAL)
ATTN: KEITH A BARRITT PHONE NO : 202-783-5070
601 13TH STREET, N.W. SE DECISION MADE: 29-OCT-99
SUITE 500 NORTH 510(k) STATEMENT
WASHINGTON, DC 20005
DEVICE: JEL BIOS 10 (CODE NAME RD-1801)
J.F. JELENKO & CO., INC. 510(k) NO: K993136(TRADITIONAL)
ATTN: TRIDIB R DASGUPTA PHONE NO : 914-273-8600
99 BUSINESS PARK DR. SE DECISION MADE: 21-OCT-99
ARMONK, NY 10504 510(k) STATEMENT
DEVICE: JEL BIOS 18 (CODE NAME RD- 1214)
J.F. JELENKO & CO., INC. 510(k) NO: K993152(TRADITIONAL)
ATTN: TRIDIB DASGUPTA PHONE NO : 914-273-8600
99 BUSINESS PARK DR. SE DECISION MADE: 21-OCT-99
ARMONK, NY 10504 510(k) STATEMENT
DEVICE: GOLD CORE 55
JENERIC/PENTRON, INC. 510(k) NO: K993173(TRADITIONAL)
ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397
53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 26-OCT-99
WALLINGFORD, CT 06492-0724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GOLD CORE 75
JENERIC/PENTRON, INC. 510(k) NO: K993175(TRADITIONAL)
ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397
53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 26-OCT-99
WALLINGFORD, CT 06492-0724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RCNG: ROOT CANAL NEGOTIATING GEL; MODEL RCNG
JORDCO, INC. 510(k) NO: K992484(TRADITIONAL)
ATTN: HAL J OIEN PHONE NO : 503-531-3904
595 N.W. 167TH AVE. SE DECISION MADE: 14-OCT-99
BEAVERTON, OR 97006 510(k) STATEMENT
DEVICE: IRRIGATION OR INFUSION PUMP "K" PUMP
K.M.I. KOLSTER METHODS INC. 510(k) NO: K991203(TRADITIONAL)
ATTN: ALWIN H KOLSTER PHONE NO : 714-956-1964
2550 WEST ROWLAND AVE. SE DECISION MADE: 15-OCT-99
ANAHEIM, CA 92804 510(k) STATEMENT
DEVICE: K-ASSAY APO AI
KAMIYA BIOMEDICAL CO. 510(k) NO: K993345(TRADITIONAL)
ATTN: COLIN GETTY PHONE NO : 206-575-8068
910 INDUSTRY DR. SE DECISION MADE: 25-OCT-99
SEATTLE, WA 98188-3412 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-ASSAY APO B
KAMIYA BIOMEDICAL CO. 510(k) NO: K993354(TRADITIONAL)
ATTN: COLIN GETTY PHONE NO : 206-575-8068
910 INDUSTRY DR. SE DECISION MADE: 28-OCT-99
SEATTLE, WA 98188-3412 510(k) STATEMENT
DEVICE: KSEA SCBCOM
KARL STORZ ENDOSCOPY 510(k) NO: K992469(TRADITIONAL)
ATTN: KEVIN A KENNAN PHONE NO : 800-421-0837
600 CORPORATE POINTE SE DECISION MADE: 15-OCT-99
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KONICA LASER IMAGER, DRYPRO MODEL 722
KONICA CORP. 510(k) NO: K992586(TRADITIONAL)
ATTN: KAY HAMAGUCHI PHONE NO : 81 596 373609
319 AKENO, OBATA-CHO SE DECISION MADE: 29-OCT-99
WATARAI-GUN 510(k) STATEMENT
MIE-KEN, JAPAN 5190501
DEVICE: SKINTACT ECG ELECTRODES, S&W; ECG ELECTRODES
LEONHARD LANG CO. 510(k) NO: K982521(TRADITIONAL)
ATTN: BURRHUS LANG PHONE NO : 435 123 34257
ARCHENWEG 65 SE DECISION MADE: 26-OCT-99
INNSBRUCK, AUSTRIA A-6020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROTORBLADE SUTURE ANCHOR
LI MEDICAL TECHNOLOGIES, INC. 510(k) NO: K993373(SPECIAL)
ATTN: RHODEMANN LI PHONE NO : 203-944-2800
4 ARMSTRONG RD. SE DECISION MADE: 27-OCT-99
SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, M
LIGHT DIAGNOSTICS 510(k) NO: K990141(TRADITIONAL)
ATTN: CINDY PENNY PHONE NO : 909-676-8080
28835 SINGLE OAK DR. SE DECISION MADE: 19-OCT-99
TEMECULA, CA 92590 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DR. JAHANGER'S CUTTER
M.S. JAHANGER, MD 510(k) NO: K990738(TRADITIONAL)
ATTN: MOHAMMED JAHANGER PHONE NO : 609-582-0033
440 EGG HARBOR ROAD SE DECISION MADE: 29-OCT-99
TUENERSVILLE, NJ 08012 510(k) STATEMENT
DEVICE: SUPER SOOTHER
MART TILLER CORP. 510(k) NO: K991914(TRADITIONAL)
ATTN: JIMMY DONG PHONE NO : 886 225 929119
4TH FL. NO.2 MING TSU E. RD. SE DECISION MADE: 06-OCT-99
TAIPEI, CHINA (TAIWAN) 104 510(k) STATEMENT
DEVICE: MASIMO SET RADICAL PULSE OXIMETER, LNOP-ADT, LNOP-PDT, LNOP-NEO,
MASIMO CORP. 510(k) NO: K992238(TRADITIONAL)
ATTN: JAMES J CRONIN PHONE NO : 949-250-9688
2852 KELVIN AVE. SE DECISION MADE: 08-OCT-99
IRVINE, CA 92614-5826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP -AD
MASIMO CORP. 510(k) NO: K992340(TRADITIONAL)
ATTN: JAMES J CRONIN PHONE NO : 949-250-9688
2852 KELVIN AVE. SE DECISION MADE: 08-OCT-99
IRVINE, CA 92614-5826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSICARE XP VINYL POWDER FREE MEDICAL EXAMINATION GLOVE
MAXXIM MEDICAL 510(k) NO: K992865(TRADITIONAL)
ATTN: JOYCE MOODY PHONE NO : 813-814-4817
477 COMMERCE BLVD SE DECISION MADE: 13-OCT-99
OLDSMAR, FL 34677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMBIDERM LATEX EXAMINATION GLOVES (VIOLET, BLUE , GREEN, AND PIN
MEDTEXX PARTNERS, INC. 510(k) NO: K993080(TRADITIONAL)
ATTN: E. J SMITH PHONE NO : 410-451-0639
P.O. BOX 4341 SE DECISION MADE: 20-OCT-99
CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC AVE BRIDGE STENT
MEDTRONIC AVE, INC. 510(k) NO: K993145(SPECIAL)
ATTN: SUSAN WALTON PHONE NO : 707-591-7315
2330A CIRCADIAN WAY SE DECISION MADE: 21-OCT-99
SANTA ROSA, CA 95407-5415 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ETCO2 VITAL SIGNS MODULE
MENNEN MEDICAL, INC. 510(k) NO: K983864(TRADITIONAL)
ATTN: KENNETH RAICHMAN PHONE NO : 972 893 83030
KIRYAT WEIZMANN SE DECISION MADE: 08-OCT-99
REHOVOT, ISRAEL 76100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MBA
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K993057(SPECIAL)
ATTN: CHESTER MCCOY PHONE NO : 801-253-1600
1600 WEST MERIT PKWY. SE DECISION MADE: 05-OCT-99
SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTELLISYSTEM II COLOR MONITOR
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K993341(SPECIAL)
ATTN: CHESTER MCCOY PHONE NO : 801-253-1600
1600 WEST MERIT PKWY. SE DECISION MADE: 25-OCT-99
SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPRING-WOUND EPIDURAL CATHETER
MICOR INC. 510(k) NO: K991879(TRADITIONAL)
ATTN: CHARLES W ESLEEP PHONE NO : 412-487-1113
2855 OXFORD BLVD. SE DECISION MADE: 28-OCT-99
ALLISON PARK, PA 15101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: .010" SILVERSPEED HYDROPOPHILIC GUIDEWIRE, .014" SILVERSPED HYDR
MICRO THERAPEUTICS, INC. 510(k) NO: K993257(SPECIAL)
ATTN: TOM DAUGHTERS PHONE NO : 949-837-3700
2 GOODYEAR SE DECISION MADE: 21-OCT-99
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIP 60 (2H), MODEL 115-000-1, VIP 60 (4H), MODEL 115-000-2
MICRON CORP. 510(k) NO: K991239(TRADITIONAL)
ATTN: EIJI SUZUKI PHONE NO : 813 372 60396
SE DECISION MADE: 18-OCT-99
510(k) STATEMENT
DEVICE: MICROWAVE DELIVERY SYSTEM, MODEL MMC-300
MICROWAVE MEDICAL, INC. 510(k) NO: K991456(TRADITIONAL)
ATTN: GREG HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 25-OCT-99
IRVINE, CA 92606 510(k) STATEMENT
DEVICE: VIRGO MRI SYSTEM
MILLENNIUM TECHNOLOGY SERVICES 510(k) NO: K990153(TRADITIONAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640
200 GREGORY LN., #C-100 SE DECISION MADE: 08-OCT-99
PLEASANT HILL, CA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OBC-085 BREAST ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K993233(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 414-524-1402
N8 W22520 JOHNSON DR., UNIT K SE DECISION MADE: 15-OCT-99
JOHNSON DR., CORPORATE CENTER 510(k) STATEMENT
WAUKESHA, WI 53186
DEVICE: QWH-085 WRIST ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K993235(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 414-524-1402
N8 W22520 JOHNSON DR., UNIT K SE DECISION MADE: 15-OCT-99
JOHNSON DR., CORPORATE CENTER 510(k) STATEMENT
WAUKESHA, WI 53186
DEVICE: QSC-085 SHOULDER ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K993279(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 414-525-1402
N8 W22520 JOHNSON DR., UNIT K SE DECISION MADE: 15-OCT-99
JOHNSON DR., CORPORATE CENTER 510(k) STATEMENT
WAUKESHA, WI 53186
DEVICE: IV ADMINISTRATION SET
NEW ALLIANCE OF INDEPENDENT MEDICA510(k) NO: K992266(TRADITIONAL)
ATTN: EDWARD THIBON PHONE NO : 626-445-3090
99 W. SANDRA AVE. SE DECISION MADE: 27-OCT-99
ARCADIA, CA 91007 510(k) STATEMENT
DEVICE: NEUROFAX, MODEL EEG-1100A
NIHON KOHDEN, INC. 510(k) NO: K992742(TRADITIONAL)
ATTN: BONNIE BISHOP PHONE NO : 949-250-3959
2601 CAMPUS DR. SE DECISION MADE: 14-OCT-99
IRVINE, CA 92612-1601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PREFERENCE TREATMENT SYSTEM
NORTHWEST MEDICAL PHYSICS EQUIPMEN510(k) NO: K983793(TRADITIONAL)
ATTN: LEE MYERS PHONE NO : 425-672-2841
21031 67TH AVE. WEST SE DECISION MADE: 05-OCT-99
LYNNWOOD, WA 98036 510(k) STATEMENT
DEVICE: CET PROSTATE APPLICATOR SET, PART NUMBER 089.066
NUCLETRON CORP. 510(k) NO: K990990(TRADITIONAL)
ATTN: RALPH E SHUPING PHONE NO : 410-312-4100
7080 COLUMBIA GATEWAY DRIVE SE DECISION MADE: 07-OCT-99
COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVASIVE GUIDED SPINAL ARTHROSCOPY SYSTEM
NUVASIVE, INC. 510(k) NO: K990324(TRADITIONAL)
ATTN: STEVE REITZLER PHONE NO : 619-977-1465
13221 MARICOTTE PLACE SE DECISION MADE: 05-OCT-99
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVASIVE SPINAL ARTHROSCOPE, MODELS 0, 30 AND 70 DEGREES
NUVASIVE, INC. 510(k) NO: K992782(TRADITIONAL)
ATTN: STEVE REITZLER PHONE NO : 858-271-7070
10065 OLD GROVE ROAD, SUITE A SE DECISION MADE: 05-OCT-99
SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DAILY
OCU-EASE OPTICAL PRODUCTS, INC. 510(k) NO: K992466(TRADITIONAL)
ATTN: CHARLES R VERMETTE PHONE NO : 510-724-0384
629 TENNENT AVE. SE DECISION MADE: 04-OCT-99
PINOLE, CA 94564 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MASS (MICRO-ACCESS SPINE SYSTEM)
OMNI-TRACT SURGICAL, DIV. MINN. SC510(k) NO: K992583(TRADITIONAL)
ATTN: MICHAEL PONTIUS PHONE NO : 612-623-0396
1100 NEW BRIGHTON BLVD. SE DECISION MADE: 29-OCT-99
MINNEAPOLIS, MN 55413-1660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPAP
OPAP, INC. 510(k) NO: K991926(TRADITIONAL)
ATTN: WILLIAM T HART PHONE NO : 209-295-5562
26037 SUGAR PINE DR. SE DECISION MADE: 18-OCT-99
PIONEER, CA 95666-0189 510(k) STATEMENT
DEVICE: ORATEC INTERVENTIONS VULCAN EAS ELECTROTHERMAL ARTHROSCOPY SYSTE
ORATEC INTERVENTIONS, INC. 510(k) NO: K991140(TRADITIONAL)
ATTN: SHEILA RAMERMAN PHONE NO : 650-687-3475
3700 HAVEN CT. SE DECISION MADE: 25-OCT-99
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEMP TELLER - DIGITAL THERMOMETER, MODELS DT-101, DT-102, DT-103
ORIENTAL SYSTEM TECHNOLOGY INC. 510(k) NO: K992601(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511
55 NORTHERN BLVD SE DECISION MADE: 27-OCT-99
SUITE 410 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: CONTOUR SPINAL SYSTEM
ORTHO DEVELOPMENT CORP. 510(k) NO: K990986(TRADITIONAL)
ATTN: CAROL FREASIER PHONE NO : 801-553-9993
106 WEST 12200 SOUTH SE DECISION MADE: 14-OCT-99
DRAPER, UT 84020 510(k) STATEMENT
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMM
ORTHO-CLINICAL DIAGNOSTICS 510(k) NO: K993068(SPECIAL)
ATTN: MARLENE SHULMAN PHONE NO : 716-453-4041
100 INDIGO CREEK DRIVE SE DECISION MADE: 04-OCT-99
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K992366(TRADITIONAL)
ATTN: MARLENE A SHULMAN PHONE NO : 716-453-4041
100 INDIGO CREEK DR. SE DECISION MADE: 08-OCT-99
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PACIFIC IMPLANT TITANIUM ENDODONTIC POINT
PACIFIC IMPLANT, INC. 510(k) NO: K992582(TRADITIONAL)
ATTN: DANIEL J MANELLI PHONE NO : 202-261-1000
2000 M. STREET N.W. 7TH FLOOR SE DECISION MADE: 21-OCT-99
WASHINGTON, DC 20036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED MULTI-PLY EXAMINATI
PAMITEX INDUSTRIES SDN BHD 510(k) NO: K991474(TRADITIONAL)
ATTN: AZMAN ISMAIL PHONE NO : 011 606 6313122
BATU 2 1/2, JALAN RASAH SE DECISION MADE: 06-OCT-99
SEREMBAN, N.S., MALAYSIA 70300 510(k) STATEMENT
DEVICE: HEALTH-PLUS SANITEX,RELIANCE PRE-POWDERED MULTI-PLY LATEX EXAMIN
PAMITEX INDUSTRIES SDN BHD 510(k) NO: K992523(TRADITIONAL)
ATTN: SAID AWANG PHONE NO : 606 631 3122
2 1/2 MILES, JALAN RASAH SE DECISION MADE: 18-OCT-99
SEREMBAN, NAGERI SEMBILAN 510(k) STATEMENT
DARUL KHUSUS, MALAYSIA 70300
DEVICE: HEALTH-PLUS, SANITEX, RELIANCE (50 MICROGRAMS)
PAMITEX INDUSTRIES SDN BHD 510(k) NO: K993093(TRADITIONAL)
ATTN: SAID AWANG PHONE NO : 606 631 3122
2 1/2 MILES, JALAN RASAH SE DECISION MADE: 29-OCT-99
SEREMBAN, NAGERI SEMBILAN 510(k) STATEMENT
DARUL KHUSUS, MALAYSIA 70300
DEVICE: HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATINO GL
PAMITEX INDUSTRIES SDN BHD 510(k) NO: K993097(TRADITIONAL)
ATTN: SAID AWANG PHONE NO : 606 631 3122
2 1/2 MILES, JALAN RASAH SE DECISION MADE: 27-OCT-99
SEREMBAN, NAGERI SEMBILAN 510(k) STATEMENT
DARUL KHUSUS, MALAYSIA 70300
DEVICE: POWDER FREE (SILICON COATED) LATEX EXAMINATION GLOVES WITH PROTE
PAN-CENTURY RUBBER PRODUCTS SDN. B510(k) NO: K993287(TRADITIONAL)
ATTN: H.R.K. MURTHY PHONE NO : 60 07 2518551
LOT 230, JALAN TIMAH 2, SE DECISION MADE: 29-OCT-99
PASIR GUDANG INDUSTRIAL ESTATE 510(k) STATEMENT
PASIR GUDANG, JOHOR, MALAYSIA 81700
DEVICE: PASCO MIC AND MIC/ID PANELS, TROVAFLOXACIN
PASCO LABORATORIES, INC. 510(k) NO: K992507(TRADITIONAL)
ATTN: LINDA K DILLON PHONE NO : 800-321-9813
12750 WEST 42ND AVE. SE DECISION MADE: 08-OCT-99
WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASCO MIC AND MIC/ID PANELS, MEROPENEM
PASCO LABORATORIES, INC. 510(k) NO: K992546(TRADITIONAL)
ATTN: LINDA K DILLON PHONE NO : 303-423-9504
12750 WEST 42ND AVE. SE DECISION MADE: 12-OCT-99
WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASCO MIC AND MIC/ID PANELS, CEFTRIAXONE
PASCO LABORATORIES, INC. 510(k) NO: K992562(TRADITIONAL)
ATTN: LINDA K DILLON PHONE NO : 303-423-9504
12750 WEST 42ND AVE. SE DECISION MADE: 13-OCT-99
WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASCO MIC AND MIC/ID PANELS, CEFOTAXIME
PASCO LABORATORIES, INC. 510(k) NO: K992568(TRADITIONAL)
ATTN: LINDA K DILLON PHONE NO : 303-423-9504
12750 WEST 42ND AVE. SE DECISION MADE: 14-OCT-99
WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASCO MIC AND MIC/ID PANELS, CHLORAMPHENICOL
PASCO LABORATORIES, INC. 510(k) NO: K992593(TRADITIONAL)
ATTN: LINDA K DILLON PHONE NO : 800-321-9813
12750 WEST 42ND AVE. SE DECISION MADE: 14-OCT-99
WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASCO MIC AND MIC/ID PANELS, PENICILLIN
PASCO LABORATORIES, INC. 510(k) NO: K992646(TRADITIONAL)
ATTN: LINDA K DILLON PHONE NO : 303-423-9504
12750 WEST 42ND AVE. SE DECISION MADE: 19-OCT-99
WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASCO MIC AND MIC/ID PANELS, ERYTHROMYCIN
PASCO LABORATORIES, INC. 510(k) NO: K992647(TRADITIONAL)
ATTN: LINDO K DILLON PHONE NO : 303-423-9504
12750 WEST 42ND AVE. SE DECISION MADE: 19-OCT-99
WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERMOBIL POWERED WHEELCHAIR 1280
PERMOBIL A.B. 510(k) NO: K991658(ABBREVIATED)
ATTN: BENGT PERSSON PHONE NO : 468 929 150
ENGELBREKTS VAG 101 SE DECISION MADE: 08-OCT-99
SOLLENTUNA, SWEDEN S-191 62 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUICKSCREEN WORKPLACE DRUG SCREENING TEST, MODEL 9147 25C
PHAMATECH 510(k) NO: K992685(SPECIAL)
ATTN: CARL A MONGIOVI PHONE NO : 619-635-5840
9265 ACTIVITY RD., #112-113 SE DECISION MADE: 06-OCT-99
SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178
PHAMATECH 510(k) NO: K993165(SPECIAL)
ATTN: CARL A MONGIOVI PHONE NO : 858-635-5840
9265 ACTIVITY RD., #112-113 SE DECISION MADE: 20-OCT-99
SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS GYROSCAN INTERA (*)
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K992533(TRADITIONAL)
ATTN: PETER ALTMAN PHONE NO : 203-926-7031
710 BRIDGEPORT AVE. SE DECISION MADE: 18-OCT-99
SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIEWPOINT ENT/ORTHOPEDIC OPTION
PICKER INTERNATIONAL, INC. 510(k) NO: K991256(TRADITIONAL)
ATTN: ELAINE K KEELER PHONE NO : 440-473-5591
595 MINER RD. SE DECISION MADE: 08-OCT-99
HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BEACON-P, MODEL 211059
PICKER INTERNATIONAL, INC. 510(k) NO: K992335(TRADITIONAL)
ATTN: RONALD J MARTONE PHONE NO : 440-473-7651
595 MINER RD. SE DECISION MADE: 07-OCT-99
HIGHLAND HEIGHTS, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCAREASE SHEETS & SCAREASE GEL
PILLAR SURGICAL 510(k) NO: K991970(TRADITIONAL)
ATTN: ROB FRITZENKOTTER PHONE NO : 619-295-6511
PO BOX 8141 SE DECISION MADE: 25-OCT-99
LA JOLLA, CA 92038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIPPY
PILLAR TECHNOLOGY, INC. 510(k) NO: K983808(TRADITIONAL)
ATTN: CHRIS TINSLEY PHONE NO : 316-325-2629
1101 ILLINOIS SE DECISION MADE: 14-OCT-99
NEODESHA, KS 66757 510(k) STATEMENT
DEVICE: SDB CERCLAGE SYSTEM
PIONEER LABORATORIES, INC. 510(k) NO: K992616(TRADITIONAL)
ATTN: BURNS SEVERSON PHONE NO : 906-226-9909
375 RIVER PARK CIRCLE SE DECISION MADE: 27-OCT-99
MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEX BUTTON
PIONEER LABORATORIES, INC. 510(k) NO: K992617(TRADITIONAL)
ATTN: BURNS SEVERSON PHONE NO : 906-226-9909
375 RIVER PARK CIRCLE SE DECISION MADE: 27-OCT-99
MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRICOTHYROTOMY TUBE
POLAMEDCO, INC. 510(k) NO: K983000(TRADITIONAL)
ATTN: JERRY W HARRER PHONE NO : 310-577-1422
4054 GLENCOE AVE. SE DECISION MADE: 27-OCT-99
MARINA DEL REY, CA 90292-5608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER
POROUS MEDIA CORP. 510(k) NO: K990276(TRADITIONAL)
ATTN: ROCHELLE M MICKSCHL PHONE NO : 651-653-2000
1350 HAMMOND RD. SE DECISION MADE: 01-OCT-99
ST. PAUL, MN 55110 510(k) STATEMENT
DEVICE: PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES
PURILENS, INC. 510(k) NO: K991965(TRADITIONAL)
ATTN: RICHARD E LIPPMAN PHONE NO : 301-770-9590
12300 TWINBROOK PARKWAY SE DECISION MADE: 01-OCT-99
SUITE 625 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20852
DEVICE: PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI
PURITAN BENNETT CORP. 510(k) NO: K993088(SPECIAL)
ATTN: TONY KEAVENEY PHONE NO : 314-498-3365
2200 FARADAY AVENUE SE DECISION MADE: 08-OCT-99
ST. CHARLES, MO 63304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM
PURITAN BENNETT CORP. 510(k) NO: K993220(SPECIAL)
ATTN: TONY KEAVENEY PHONE NO : 314-498-3365
3 MISSOURI RESEARCH PARK DR. SE DECISION MADE: 22-OCT-99
ST.CHARLES, MO 63304-5685 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SERAQUEST EB VCA IGG
QUEST INTL., INC. 510(k) NO: K990410(TRADITIONAL)
ATTN: ROBERT A CORT PHONE NO : 305-948-8788
1938 N.E. 148TH TERR. SE DECISION MADE: 28-OCT-99
NORTH MIAMI, FL 33181 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SERAQUEST EB VAC IGM
QUEST INTL., INC. 510(k) NO: K990977(TRADITIONAL)
ATTN: ROBERT A CORT PHONE NO : 305-948-8788
1938 N.E. 148TH TERR. SE DECISION MADE: 06-OCT-99
NORTH MIAMI, FL 33181 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REDI-SCREEN
REDWOOD BIOTECH INC. 510(k) NO: K993100(SPECIAL)
ATTN: JANIS FREESTONE PHONE NO : 650-691-4770
2440 LEGHORN ST. SE DECISION MADE: 06-OCT-99
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARIA LX CPAP SYSTEM
RESPIRONICS, INC. 510(k) NO: K993307(SPECIAL)
ATTN: DAVID J VANELLA PHONE NO : 724-733-5866
1001 MURRY RIDGE DR. SE DECISION MADE: 27-OCT-99
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIRTUOSO LX SMART CPAP SYSTEM
RESPIRONICS, INC. 510(k) NO: K993433(SPECIAL)
ATTN: DAVID J VANELLA PHONE NO : 724-733-5866
1001 MURRY RIDGE DR. SE DECISION MADE: 27-OCT-99
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GINRAM ENDOCIC SINGLE OVAL PORT (MODEL NO. 720195)
RI MOS. S.R.L. 510(k) NO: K992926(TRADITIONAL)
ATTN: ADENA S RIEMER PHONE NO : 978-371-0066
100 MAIN STREET SE DECISION MADE: 26-OCT-99
SUITE 120 510(k) SUMMARY AVAILABLE FROM FDA
CONCORD, MA 01742
DEVICE: FLEXIBLE FIBERSCOPES & ACCESSORIES
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K990397(TRADITIONAL)
ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY. SE DECISION MADE: 25-OCT-99
VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE
SAFESKIN CORP. 510(k) NO: K992830(TRADITIONAL)
ATTN: EUGENE V GOORCHENKO PHONE NO : 619-509-7010
12671 HIGH BLUFF DR. SE DECISION MADE: 27-OCT-99
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAYPAX WEB CLINICAL SYSTEM
SAMSUNG SDS CO., LTD 510(k) NO: K992426(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 513-786-7458
2001 EAST OAKSHORES DRIVE SE DECISION MADE: 13-OCT-99
CROSSROADS, TX 76227 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SELECT-SUTTER MICRO BIPOLAR FORCEPS
SELECT MEDIZINTECHNIK HERMANN SUTT510(k) NO: K992760(TRADITIONAL)
ATTN: ANITA THIBEAULT PHONE NO : 678-461-5559
9070 BLUFFVIEW TRACE SE DECISION MADE: 25-OCT-99
ROSWELL, GA 30076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES
SHANGHAI COSMOS CORP. 510(k) NO: K992271(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511
55 NORTHERN BLVD., SUITE 410 SE DECISION MADE: 01-OCT-99
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
SHANGHAI COSMOS CORP. 510(k) NO: K992272(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511
55 NORTHERN BLVD., SUITE 410 SE DECISION MADE: 01-OCT-99
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG GREAT VISION PLASTIC 510(k) NO: K992555(TRADITIONAL)
ATTN: KAREN ABEL PHONE NO : 909-590-9358
13945 MAGNOLIA AVE SE DECISION MADE: 14-OCT-99
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG GREAT VISION PLASTIC 510(k) NO: K992861(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511
13945 MAGNOLIA AVE SE DECISION MADE: 06-OCT-99
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSI-PRO, DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVE
SHIJIAZHUANG HONGRAY PLASTIC PRODU510(k) NO: K992922(TRADITIONAL)
ATTN: GUI-XI LIU PHONE NO : 011 863 113613127
NO. 135 XIN-HUA WEST RD. SE DECISION MADE: 06-OCT-99
SHIJIAZHUANG, CHINA 050081 510(k) STATEMENT
DEVICE: SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES
SHINEMOUND ENTERPRISE, INC. 510(k) NO: K993231(TRADITIONAL)
ATTN: HUAN-CHUNG LI PHONE NO : 978-436-9980
17A STERLING RD. SE DECISION MADE: 27-OCT-99
NORTH BILLERICA, MA 01862 510(k) STATEMENT
DEVICE: SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLO
SHINEMOUND ENTERPRISE, INC. 510(k) NO: K993240(TRADITIONAL)
ATTN: HUAN-CHUNG LI PHONE NO : 978-436-9980
17A STERLING RD. SE DECISION MADE: 27-OCT-99
NORTH BILLERICA, MA 01862 510(k) STATEMENT
DEVICE: P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM
SIMS DELTEC, INC. 510(k) NO: K992880(TRADITIONAL)
ATTN: LISA J STONE PHONE NO : 651-633-2556
1265 GREY FOX RD. SE DECISION MADE: 19-OCT-99
ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL#
SIMS PORTEX, INC. 510(k) NO: K992471(TRADITIONAL)
ATTN: TIMOTHY J TALCOTT PHONE NO : 603-352-3812
10 BOWMAN DR. SE DECISION MADE: 22-OCT-99
KEENE, NH 03431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ST-302 INFRAREX
SKYLARK DEVICE CO., LTD. 510(k) NO: K990233(TRADITIONAL)
ATTN: GEORGE K. C CHEN PHONE NO : 886 225 979005
12FL, 34, SEC. 3 SE DECISION MADE: 27-OCT-99
CHUNG SHAN N. ROAD 510(k) STATEMENT
TAIPEI, CHINA (TAIWAN)
DEVICE: IQ NASAL MASK, MODEL P/N 50160
SLEEPNET CORP. 510(k) NO: K993269(SPECIAL)
ATTN: PAUL R CHIESA PHONE NO : 603-624-1911
1050 PERIMETER RD., SE DECISION MADE: 27-OCT-99
LOCKHEED AIR CENTER 510(k) STATEMENT
MANCHESTER, NH 03103
DEVICE: DYONICS VARICOSE VEIN ABLATION BLADE
SMITH & NEPHEW, INC. 510(k) NO: K990723(TRADITIONAL)
ATTN: DEBORAH CONNORS PHONE NO : 978-749-1000
160 DASCOMB RD. SE DECISION MADE: 05-OCT-99
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS
SMITH & NEPHEW, INC. 510(k) NO: K991026(ABBREVIATED)
ATTN: EHAB M ESMAIL PHONE NO : 901-396-2121
1450 BROOKS RD. SE DECISION MADE: 22-OCT-99
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENTIL-A ORAL PROTECTOR
SOMATICS, INC. 510(k) NO: K992269(TRADITIONAL)
ATTN: RICHARD ABRAMS PHONE NO : 847-234-6761
910 SHERWOOD DR., UNIT 17 SE DECISION MADE: 25-OCT-99
LAKE BLUFF, IL 60044 510(k) STATEMENT
DEVICE: SORING GMBH, ARCO 3000, ARCO 2000, ARCO 1000, MBC 601, MBC 600
SORING GMBH MEDIZINTECHNIK 510(k) NO: K993265(SPECIAL)
ATTN: CARL ALLETTO PHONE NO : 513-786-7458
3200 DOGWOOD COURT SE DECISION MADE: 22-OCT-99
CINCINNATI, OH 45140 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 125 IMPLANT SEEDS, MODEL STM1251
SOURCETECH MEDICAL, L.L.C. 510(k) NO: K991280(TRADITIONAL)
ATTN: DAVID T SIERACKI PHONE NO : 630-933-7610
295 E. LIES RD. SE DECISION MADE: 20-OCT-99
CAROL STREAM, IL 60188 510(k) STATEMENT
DEVICE: CARDIOQUANT TROPONIN I TEST
SPECTRAL DIAGNOSTICS INC. 510(k) NO: K992127(TRADITIONAL)
ATTN: FRANCEE S BOCHES PHONE NO : 305-593-1991
5550 N.W. 102 PLACE SE DECISION MADE: 04-OCT-99
MIAMI, FL 33178 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER
SPECTRANETICS CORP. 510(k) NO: K990713(TRADITIONAL)
ATTN: MICHAEL J QUINN PHONE NO : 719-633-8333
96 TALAMINE CT. SE DECISION MADE: 22-OCT-99
COLORADO SPRINGS, CO 80907-5159 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECTRUM DESIGNS SPECTRAGEL
SPECTRUM DESIGNS, INC. 510(k) NO: K992522(TRADITIONAL)
ATTN: JIM DISHMAN PHONE NO : 800-239-6399
6387 B ROSE LANE SE DECISION MADE: 26-OCT-99
CARPINETERIA, CA 93013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAUTERY CLAMP AND BATTERY PACK POWER SUPPLY
STARION INSTRUMENTS 510(k) NO: K992460(TRADITIONAL)
ATTN: GEORGE HERMANN PHONE NO : 408-741-8773
22900 CONGRESS SPRINGS ROAD SE DECISION MADE: 05-OCT-99
SARATOGA, CA 95070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STENTOR, PAGEVIEW
STENTOR, INC 510(k) NO: K992698(TRADITIONAL)
ATTN: GARY J ALLSEBROOK PHONE NO : 510-276-2648
16303 PANORAMIC WAY SE DECISION MADE: 25-OCT-99
SAN LEANDRO, CA 94578 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARIATRIC LAPAROSCOPE, MODEL 367
STRYKER ENDOSCOPY 510(k) NO: K993045(TRADITIONAL)
ATTN: ROBERT H DAHLA PHONE NO : 408-567-2401
2590 WALSH AVE. SE DECISION MADE: 27-OCT-99
SANTA CLARA, CA 95051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM
STRYKER INSTRUMENTS 510(k) NO: K991696(TRADITIONAL)
ATTN: NICOLE PETTY PHONE NO : 616-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 25-OCT-99
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER T4 HOOD, STRYKER T4 ZIPPERED TOGA, STRYKER T4 PULLOVER T
STRYKER INSTRUMENTS 510(k) NO: K993148(SPECIAL)
ATTN: SUZANNE VELAZQUEZ PHONE NO : 616-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 15-OCT-99
KALAMAZOO, MI 49001 510(k) STATEMENT
DEVICE: ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800
SULZER CARBOMEDICS, INC. 510(k) NO: K992056(TRADITIONAL)
ATTN: ROBERT M WOLFARTH PHONE NO : 512-435-3467
1300 EAST ANDERSON LN. SE DECISION MADE: 12-OCT-99
AUSTIN, TX 78752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM
SULZER SPINE-TECH 510(k) NO: K992276(TRADITIONAL)
ATTN: JANELL A COLLEY PHONE NO : 612-832-6205
7375 BUSH LAKE RD. SE DECISION MADE: 01-OCT-99
MINNEAPOLIS, MN 55439-2027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES
SUPERMAX SDN BHD 510(k) NO: K993258(TRADITIONAL)
ATTN: STANLEY THAI PHONE NO : 603 657 2328
LOT 42, JALAN BRP 9/2, BUKIT SE DECISION MADE: 27-OCT-99
RAHMAN PUTRA,PUTRA INDUSTRIAL 510(k) STATEMENT
47000 SUNGAI BULOH-SELANGOR, MALAYSIA
DEVICE: SNT IMAGE ANALYSIS SYSTEM
SURGICAL NAVIGATION TECHNOLOGIES, 510(k) NO: K992354(TRADITIONAL)
ATTN: ROGER N WHITE PHONE NO : 303-439-9709
530 COMPTON ST. SE DECISION MADE: 12-OCT-99
BROOMFIELD, CO 80020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTEC-E IRRIGATION SYSTEM 2
SYBRON DENTAL SPECIALTIES INC. 510(k) NO: K992195(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 08-OCT-99
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD
SYNTHES (USA) 510(k) NO: K990637(TRADITIONAL)
ATTN: ANGELA SILVESTRI PHONE NO : 610-647-9700
1690 RUSSELL ROAD SE DECISION MADE: 22-OCT-99
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM
SYNTHES (USA) 510(k) NO: K992837(TRADITIONAL)
ATTN: ANGELA J SILVESTRI PHONE NO : 610-647-9700
1600 RUSSELL RD. SE DECISION MADE: 25-OCT-99
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUICKSTRIP ONE STEP OPIATES TEST
SYNTRON BIORESEARCH, INC. 510(k) NO: K993490(TRADITIONAL)
ATTN: CLEVE W LAIRD PHONE NO : 805-522-6223
1420 LOS ANGELES AVE. SE DECISION MADE: 29-OCT-99
SUITE 201 510(k) SUMMARY AVAILABLE FROM FDA
SIMI VALLEY, CA 93065
DEVICE: QUICKPAC II ONE STEP OPIATES TEST
SYNTRON BIORESEARCH, INC. 510(k) NO: K993491(TRADITIONAL)
ATTN: CLEVE W LAIRD PHONE NO : 805-522-6223
1420 LOS ANGELES AVE. SE DECISION MADE: 29-OCT-99
SUITE 201 510(k) SUMMARY AVAILABLE FROM FDA
SIMI VALLEY, CA 93065
DEVICE: MINI-PORT
TAUT, INC. 510(k) NO: K992904(TRADITIONAL)
ATTN: RONALD KENSETH PHONE NO : 630-232-2507
2571 KANEVILLE COURT SE DECISION MADE: 05-OCT-99
GENEVA, IL 60134 510(k) STATEMENT
DEVICE: INTRADUCER
TAUT, INC. 510(k) NO: K992907(TRADITIONAL)
ATTN: RONALD KENSETH PHONE NO : 630-232-2507
2571 KANEVILLE COURT SE DECISION MADE: 05-OCT-99
GENEVA, IL 60134 510(k) STATEMENT
DEVICE: TECHNOSANAT KRYO TSK 2005
TECHNOSANAT INNOVATIVE MEDIZINTECH510(k) NO: K992536(TRADITIONAL)
ATTN: WILLIAM KELLEY PHONE NO : 949-660-2950
2525 MCGAW AVE SE DECISION MADE: 08-OCT-99
IRVINE, CA 92623 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIRST CLASS POWER RECLINE SEATING SYSTEM, MODEL S500
TEFTEC CORP. 510(k) NO: K992627(TRADITIONAL)
ATTN: THOMAS E FINCH PHONE NO : 830-885-7588
6929 OLD SPRING BRANCH RD. SE DECISION MADE: 25-OCT-99
SPRING BRANCH, TX 78070-5104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIRSTCLASS POWER TILT AND RECLINE SEAT SYSTEM, MODEL S400
TEFTEC CORP. 510(k) NO: K992628(TRADITIONAL)
ATTN: THOMAS E FINCH PHONE NO : 830-885-7588
6929 OLD SPRING BRANCH RD. SE DECISION MADE: 25-OCT-99
SPRING BRANCH, TX 78070-5104 510(k) STATEMENT
DEVICE: TES-20
TES ELECTRICAL ELECTRONIC CORP. 510(k) NO: K992425(TRADITIONAL)
ATTN: MIKE Z CHEN PHONE NO : 886 223 939142
NO.57 JEN-AI ROAD SEC. 2 SE DECISION MADE: 19-OCT-99
TAIPEI, TAIWAN 300, CHINA 300 510(k) STATEMENT
DEVICE: TG MEDICAL POWDERED NITRILE EXAMINATION GLOVES
TG MEDICAL SDN BHD 510(k) NO: K992360(TRADITIONAL)
ATTN: WEE-CHAI LIM PHONE NO : 603 392 7880
LOT 5091, JALAN TERATAI, BT 5, SE DECISION MADE: 12-OCT-99
OFF JLN MERU 510(k) STATEMENT
KLANG, SELANGOR D.E., MALAYSIA 41050
DEVICE: TG MEDICAL POWDERED NITRILE BLUE EXAMINATION GLOVES
TG MEDICAL SDN BHD 510(k) NO: K992841(TRADITIONAL)
ATTN: WEE-CHAI LIM PHONE NO : 603 392 7880
LOT 5091, JALAN TERATAI, BT 5, SE DECISION MADE: 29-OCT-99
OFF JLN MERU 510(k) STATEMENT
KLANG, SELANGOR D.E., MALAYSIA 41050
DEVICE: THE LEADAWAY
THERAPY EQUIPMENT INC. 510(k) NO: K992372(TRADITIONAL)
ATTN: GLENN BUCHAN PHONE NO : 800-940-6962
13860 WELLINGTON TRACE, #310 SE DECISION MADE: 13-OCT-99
WEST PALM BEACH, FL 33414 510(k) STATEMENT
DEVICE: TOSHIBA RTP9211J-G11, J-ADVANCED IMAGE INTENSIFIER (I.I.)
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K993038(TRADITIONAL)
ATTN: DIANA THORSON PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 07-OCT-99
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92681-2068
DEVICE: ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM
TRANSFUSION TECHNOLOGIES CORP. 510(k) NO: K992723(TRADITIONAL)
ATTN: JOHN J SOKOLOWSKI PHONE NO : 508-655-2277
9 ERIE DR. SE DECISION MADE: 18-OCT-99
NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM
TRIMEDYNE, INC. 510(k) NO: K992574(TRADITIONAL)
ATTN: SUSAN H GAMBLE PHONE NO : 949-559-5300
2801 BARRANCA RD. SE DECISION MADE: 29-OCT-99
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERIOGLAS- BIOGLASS BONE GRAFT PARTICULATE
U.S. BIOMATERIALS CORP. 510(k) NO: K992416(TRADITIONAL)
ATTN: ALBERT FOSMOE PHONE NO : 904-462-7660
ONE PROGRESS BLVD. SE DECISION MADE: 15-OCT-99
ALACHUA, FL 32615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOREZ
ULTRADENT PRODUCTS, INC. 510(k) NO: K992097(TRADITIONAL)
ATTN: SCOTT E MOORE PHONE NO : 801-572-4200
505 WEST 10200 SOUTH SE DECISION MADE: 26-OCT-99
SOUTH JORDAN, UT 84095 510(k) STATEMENT
DEVICE: ENDO-EZE MOTOR AND HANDPIECE
ULTRADENT PRODUCTS, INC. 510(k) NO: K992380(TRADITIONAL)
ATTN: SCOTT E MOORE PHONE NO : 801-572-4200
505 WEST 10200 SOUTH SE DECISION MADE: 13-OCT-99
SOUTH JORDAN, UT 84095 510(k) STATEMENT
DEVICE: NEXT GENERATION RODDING SYSTEM
UNITED STATES SURGICAL CORP. 510(k) NO: K992784(TRADITIONAL)
ATTN: LUIS NESPRIDO PHONE NO : 203-845-1552
150 GLOVER AVE. SE DECISION MADE: 27-OCT-99
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEXIDE BIPOLAR FORCEPS II** DEVICE
UNITED STATES SURGICAL CORP. 510(k) NO: K993055(TRADITIONAL)
ATTN: CHRISTOPHER A GRAHAM PHONE NO : 203-845-1390
150 GLOVER AVE. SE DECISION MADE: 05-OCT-99
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V.T.S., INC. (V.T.-3)
V.T.S.,INC. 510(k) NO: K992442(TRADITIONAL)
ATTN: DENNIS BELL PHONE NO :
701 S. MAIN SE DECISION MADE: 05-OCT-99
NEWKIRK, OK 74647 510(k) STATEMENT
DEVICE: NUTRISAFE EXTENSION TUBE
VYGON CORP. 510(k) NO: K991918(TRADITIONAL)
ATTN: ROBERT SCHIFF PHONE NO : 973-227-1830
1129 BLOOMFIELD AVE. SE DECISION MADE: 29-OCT-99
WEST CALDWELL, NJ 07006 510(k) STATEMENT
DEVICE: SURGEON "POWDER-FREE" GLOVES, LATEX, STERILE
WEAR SAFE MALAYSIA SDN. BHD. 510(k) NO: K992679(TRADITIONAL)
ATTN: CLAUDE COTTET PHONE NO : 03 376 3525
LOT 1, LEBOH HISHAMUDDIN SATU, SE DECISION MADE: 21-OCT-99
NORTH KLANG STRAITS IND. AREA 510(k) STATEMENT
PORT KLANG, SELANGOR, D.E., MALAYSIA 42000
DEVICE: MAPS 10000
WEB LINK MEDICAL 510(k) NO: K992560(TRADITIONAL)
ATTN: MELISSA MAHALL PHONE NO : 301-623-2500
11800 BALTIMORE AVE SE DECISION MADE: 29-OCT-99
SUITE 105 510(k) SUMMARY AVAILABLE FROM FDA
BELTSVILLE, MD 20850
DEVICE: DERMAGRIP POWDER FREE BLUE NITRILE EXAMINATION GLOVE, NON STERIL
WRP SPECIALTY PRODUCTS SDN. BHD. 510(k) NO: K990750(TRADITIONAL)
ATTN: CHENG HEAN KHOO PHONE NO : 603 846 2055
LOT11, JL.2,KAWASAN PERUSAHAAN SE DECISION MADE: 15-OCT-99
BANDAR BARU SLAK TINGGI 510(k) SUMMARY AVAILABLE FROM FDA
SELANGOR DAURL EHSAN, SEPANG, MALAYSIA 43900
DEVICE: DERMAGRIP POWDER FREE NITRILE EXAMINATION GLOVE, NON STERILE
WRP SPECIALTY PRODUCTS SDN. BHD. 510(k) NO: K990752(TRADITIONAL)
ATTN: CHENG HEAN KHOO PHONE NO : 603 846 2055
LOT11, JL.2,KAWASAN PERUSAHAAN SE DECISION MADE: 18-OCT-99
BANDAR BARU SLAK TINGGI 510(k) SUMMARY AVAILABLE FROM FDA
SELANGOR DAURL EHSAN, SEPANG, MALAYSIA 43900
DEVICE: XRT 600 R/F, WRF 0600
WUESTEC MEDICAL, INC. 510(k) NO: K992603(TRADITIONAL)
ATTN: BRENDA S DAVIS PHONE NO : 334-408-0200
5600 COMMERCE BLVD., EAST SE DECISION MADE: 25-OCT-99
MOBILE, AL 36619-0037 510(k) STATEMENT
DEVICE: ACCUGUIDE MUSCLE INJECTION MONITOR
XOMED SURGICAL PRODUCTS, INC. 510(k) NO: K990793(TRADITIONAL)
ATTN: DAVID TIMLIN PHONE NO : 904-279-7532
6743 SOUTHPOINT DR. N. SE DECISION MADE: 22-OCT-99
JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE
XOMED, INC. 510(k) NO: K992869(TRADITIONAL)
ATTN: MARTIN D SARGENT PHONE NO : 904-279-7586
6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 07-OCT-99
JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZMR HIP SYSTEM-REVISION TAPER
ZIMMER, INC. 510(k) NO: K992667(TRADITIONAL)
ATTN: KAREN CAIN PHONE NO : 219-372-4219
345 E. MAIN ST. SE DECISION MADE: 27-OCT-99
WARSAW, IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZOLL M SERIES 12SL ANALYSIS OPTION
ZOLL MEDICAL CORP. 510(k) NO: K991556(TRADITIONAL)
ATTN: PAUL DIAS PHONE NO : 800-242-9150
32 SECOND AVENUE SE DECISION MADE: 21-OCT-99
BURLINGTON, MA 01803-4420 510(k) STATEMENT
TOTAL 510(k)s THIS PERIOD 279
TOTAL WITH SUMMARIES 202
TOTAL WITH STATEMENTS 77
Updated 3/6/2000
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH