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horizonal rule

510(k)s Final Decisions Rendered for April 2001

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SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
          510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-APR-2001 THROUGH 30-APR-2001
 
DEVICE: 3M ESPE HAUR
3M COMPANY                        510(k) NO: K010781(TRADITIONAL)
ATTN: SCOTT  ERICKSON             PHONE NO : 651-736-9883
3M CENTER, BLDG. 260-2B-12        SE DECISION MADE: 13-APR-01
ST PAUL, MN 55144                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-9
A & A MEDICAL, INC.               510(k) NO: K010789(TRADITIONAL)
ATTN: JIHAD  MANSOUR              PHONE NO : 770-343-8400
9370 INDUSTRIAL TRACE             SE DECISION MADE: 27-APR-01
ALPHARETTA, GA 30004-3383         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ETEST MEROPENEM
AB BIODISK                        510(k) NO: K010363(TRADITIONAL)
ATTN: ANNE  BOLMSTROM             PHONE NO : 46 873 00760
DALVAGEN 10                       SE DECISION MADE: 09-APR-01
SOLNA, SWEDEN 16956               510(k) STATEMENT

DEVICE: PICCOLO CHLORIDE TEST SYSTEM
ABAXIS INC.                       510(k) NO: K010670(TRADITIONAL)
ATTN: AMY  LEVIN                  PHONE NO : 510-675-6500
3240 WHIPPLE ROAD                 SE DECISION MADE: 26-APR-01
UNION CITY, CA 94587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO PLUM XL INFUSION PUMP
ABBOTT LABORATORIES               510(k) NO: K010924(SPECIAL)
ATTN: FRANK  POKROP               PHONE NO : 847-937-8473
DEPT.37K, BUILDING AP30           SE DECISION MADE: 06-APR-01
200 ABBOTT PARK ROAD              510(k) STATEMENT
ABBOTT PARK, IL 60064-6157

DEVICE: ACTIVHEAL SCAR MANAGEMENT DRESSING
ADVANCED MEDICAL SOLUTIONS LTD.   510(k) NO: K010245(TRADITIONAL)
ATTN: CHRIS  OAKES                PHONE NO : 011 44 1606863500
ROAD THREE,                       SE DECISION MADE: 25-APR-01
WINSFORD INDUSTRIAL ESTATE        510(k) SUMMARY AVAILABLE FROM FDA
WINSFORD, CHESHIRE, UNITED KINGDOM CW7 3PD

DEVICE: SOCON SPINAL SYSTEM
AESCULAP, INC.                    510(k) NO: K003463(SPECIAL)
ATTN: DAVID W SCHLERF             PHONE NO : 925-356-2640
200 GREGORY LANE                  SE DECISION MADE: 11-APR-01
SUITE C-100                       510(k) SUMMARY AVAILABLE FROM FDA
PLEASENT HILL, CA 94523-3389

DEVICE: MIASPAS MINITTA ANTERIOR MICRO SURGICAL TRANSTHORACIC APPROACH I
AESCULAP, INC.                    510(k) NO: K003740(TRADITIONAL)
ATTN: DAVID W SCHLERF             PHONE NO : 925-356-2640
200 GREGORY LANE                  SE DECISION MADE: 27-APR-01
SUITE C-100                       510(k) SUMMARY AVAILABLE FROM FDA
PLEASENT HILL, CA 94523-3389
 
DEVICE: DRYSTAR 4500 PRINTER, MODEL 4500
AGFA MEDICAL IMAGING              510(k) NO: K010275(TRADITIONAL)
ATTN: KIRSTEN  PAULSON            PHONE NO : 301-770-9590
12300 TWINBROOK PKWY, STE 625     SE DECISION MADE: 27-APR-01
ROCKVILLE, MD 20852               510(k) STATEMENT

DEVICE: NUVOLASE 532 MEDICAL LASER SYSTEM
AMERICAN LASER CORP.              510(k) NO: K010046(TRADITIONAL)
ATTN: DANIEL  HOEFER              PHONE NO : 801-972-1311
2417 SOUTH 3850 WEST              SE DECISION MADE: 05-APR-01
SALT LAKE CITY, UT 84120          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMS SACRAL COLPOPEXY SLING, MODEL 72403501
AMERICAN MEDICAL SYSTEMS, INC.    510(k) NO: K010931(SPECIAL)
ATTN: ELSA A LINKE                PHONE NO : 952-930-6309
10700 BREN RD., WEST              SE DECISION MADE: 09-APR-01
MINNETONKA, MN 55343              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOSCOPIC TUBE SHAFT INSTRUMENTS FOR MONOPLAR COAGULATION
ANTYLLOS MEDIZINTECHNIK GMBH      510(k) NO: K010192(TRADITIONAL)
ATTN: HARALD  JUNG                PHONE NO : 004 974 61969236
UNTERER WINKEL 3                  SE DECISION MADE: 02-APR-01
WURMLINGEN, GERMANY 78573         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURESTEP ACETAMINOPHEN/SALICYLATE TEST
APPLIED BIOTECH, INC.             510(k) NO: K010614(TRADITIONAL)
ATTN: DAVE D SMITH                PHONE NO : 858-713-9614
10237 FLANDERS CT.                SE DECISION MADE: 30-APR-01
SAN DIEGO, CA 92121               510(k) STATEMENT

DEVICE: COUCH FOR TOTAL BODY RADIATION
ARPLAY MEDICAL S.A.               510(k) NO: K010063(TRADITIONAL)
ATTN: RICHARD  BORGI              PHONE NO : 333 802 97401
1, ROUTE DE CITEAUX               SE DECISION MADE: 02-APR-01
IZEURE, COTE D'OR, FRANCE 21110   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LEAD BLOCKS
ARPLAY MEDICAL S.A.               510(k) NO: K010172(TRADITIONAL)
ATTN: RICHARD  BORGI              PHONE NO : 333 802 97401
1, ROUTE DE CITEAUX               SE DECISION MADE: 18-APR-01
IZEURE, COTE D'OR, FRANCE 21110   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRAY ADAPTERS, MULTIPLE
ARPLAY MEDICAL S.A.               510(k) NO: K010174(TRADITIONAL)
ATTN: RICHARD  BORJ               PHONE NO : 333 802 97401
1, ROUTE DE CITEAUX               SE DECISION MADE: 18-APR-01
IZEURE, COTE D'OR, FRANCE 21110   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTHREX UNIVERS 30 SHOULDER PROSTHESIS
ARTHREX, INC.                     510(k) NO: K010124(TRADITIONAL)
ATTN: VERNON  BROWN               PHONE NO : 941-643-5553
2885 SOUTH HORSESHOE DR.          SE DECISION MADE: 06-APR-01
NAPLES, FL 34104                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER
ATRIUM MEDICAL CORP.              510(k) NO: K002627(TRADITIONAL)
ATTN: REBECCA  DOLLOFF            PHONE NO : 603-880-1433
5 WENTWORTH DR.                   SE DECISION MADE: 26-APR-01
HUDSON, NH 03051                  510(k) STATEMENT

DEVICE: ULNAR HEAD IMPLANT
AVANTA ORTHOPAEDICS, INC.         510(k) NO: K010786(SPECIAL)
ATTN: LOUISE M FOCHT              PHONE NO : 858-452-8580
9369 CARROLL PARK RD., SUITE A    SE DECISION MADE: 11-APR-01
SAN DIEGO, CA 92121               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)
AVITA INTERNATIONAL CORP.         510(k) NO: K010462(TRADITIONAL)
ATTN: ALLEN  REICH                PHONE NO : 520-773-9488
900 N. SWITZER CANYON DR. #142    SE DECISION MADE: 11-APR-01
FLAGGSTAFF, AZ 86001              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTRASOUND SCANNER TYPE 2102
B-K MEDICAL A/S                   510(k) NO: K003986(TRADITIONAL)
ATTN: VILLY  BRAENDER             PHONE NO : 011 454 5970100
SANDTOFTEN 9                      SE DECISION MADE: 03-APR-01
GENTOFTE, DENMARK DK-2820         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HANSATOME MICROKERATOME
BAUSCH & LOMB, INC.               510(k) NO: K010260(TRADITIONAL)
ATTN: PAUL S KRAMSKY              PHONE NO : 949-454-4485
9342 JERONIMO ROAD                SE DECISION MADE: 27-APR-01
IRVINE, CA 92618                  510(k) STATEMENT

DEVICE: ADVIA CENTAUR RUBELLA IGG ASSAY
BAYER CORP.                       510(k) NO: K003412(TRADITIONAL)
ATTN: WILLIAM J PIGNATO           PHONE NO : 508-359-3825
63 NORTH ST.                      SE DECISION MADE: 13-APR-01
MEDFIELD, MA 02052-1688           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BAYLIS MEDICAL RF PERFORATION PROBE, MODEL RFP-265
BAYLIS MEDICAL CO., INC.          510(k) NO: K010265(TRADITIONAL)
ATTN: KRIS  SHAH                  PHONE NO : 905 602 4875
5160 EXPLORER DRIVE, UNIT 33      SE DECISION MADE: 09-APR-01
MISSISSAUGA, CANADA L4W-4T7       510(k) STATEMENT

DEVICE: IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEI
BECKMAN COULTER, INC.             510(k) NO: K010236(TRADITIONAL)
ATTN: ANNETTE  HELLIE             PHONE NO : 714-993-8767
200 SOUTH KRAEMER BLVD.           SE DECISION MADE: 05-APR-01
BREA, CA 92822                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIGIL DNASE B CONTROL
BECKMAN COULTER, INC.             510(k) NO: K010693(TRADITIONAL)
ATTN: RICHARD T ROSS, RAC         PHONE NO : 714-961-4912
200 SOUTH KRAEMER BLVD.,W-104     SE DECISION MADE: 11-APR-01
BREA, CA 92822-8000               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BD ULTRA-FINE II INSULIN SYRINGE-MINI NEEDLE, MODEL 30G * 3/16 (
BECTON DICKINSON AND COMPANY      510(k) NO: K010890(SPECIAL)
ATTN: PETER  ZURLO                PHONE NO : 201-847-6447
1 BECTON DRIVE                    SE DECISION MADE: 19-APR-01
FRANKLIN LAKES, NJ 07417-1880     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PREAMP CABLE, MODEL B400-1011PA
BETA BIOMED SERVICES, INC.        510(k) NO: K003542(TRADITIONAL)
ATTN: EJ  SMITH                   PHONE NO : 410-451-0639
P.O. BOX 4341                     SE DECISION MADE: 06-APR-01
CROFTON, MD 21114                 510(k) STATEMENT

DEVICE: RECONSTITUTION KIT & VIAL CONNECTOR
BIOJECT, INC.                     510(k) NO: K010623(TRADITIONAL)
ATTN: NANCY  GERTLAR              PHONE NO : 800-683-7221
7620 S.W. BRIDGEPORT RD.          SE DECISION MADE: 05-APR-01
PORTLAND, OR 97224                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428
BIOMERIEUX, INC.                  510(k) NO: K010550(TRADITIONAL)
ATTN: NANCY  WEAVER               PHONE NO : 314-731-8695
595 ANGLUM RD.                    SE DECISION MADE: 24-APR-01
HAZELWOOD, MO 63042               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COPELAND RESURFACING HUMERAL HEADS
BIOMET MANUFACTURING, INC.        510(k) NO: K010664(SPECIAL)
ATTN: SARA A BAILEY               PHONE NO : 219-372-1568
AIRPORT INDUSTRIAL PARK           SE DECISION MADE: 05-APR-01
P.O. BOX 587                      510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587

DEVICE: MIMIX BONE REPLACEMENT SYSTEM
BIOMET, INC.                      510(k) NO: K003494(TRADITIONAL)
ATTN: MICHELLE L MCKINLEY         PHONE NO : 219-267-6639
AIRPORT INDUSTRIAL PARK           SE DECISION MADE: 09-APR-01
P.O. BOX 587                      510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587

DEVICE: AVL HINGE KNEE SYSTEM
BIOMET, INC.                      510(k) NO: K010774(SPECIAL)
ATTN: MICHELLE L MCKINLEY         PHONE NO : 219-372-1644
56 EAST BELL                      SE DECISION MADE: 13-APR-01
P.O. BOX 587                      510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46582

DEVICE: SMARTSCREW MODEL 222006...227510
BIONX IMPLANTS, LTD.              510(k) NO: K003077(TRADITIONAL)
ATTN: GERARD S CARLOZZI           PHONE NO : 215-643-5000
1777 SENTRY PARKWAY WEST          SE DECISION MADE: 26-APR-01
BLUEBELL, PA 19422                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WUJIN #3 FEMORAL NAIL
BIOPRO, INC.                      510(k) NO: K010149(TRADITIONAL)
ATTN: ANGENA  PAREKH              PHONE NO : 810-982-7777
17 SEVENTEENTH ST.                SE DECISION MADE: 17-APR-01
PORT HURON, MI 48060              510(k) STATEMENT
 
DEVICE: TOTAL CURE
BISCO, INC.                       510(k) NO: K010196(TRADITIONAL)
ATTN: CYNDY  ORIS                 PHONE NO : 847-534-6000
1100 WEST IRVING PARK RD.         SE DECISION MADE: 05-APR-01
SCHAUMBURG, IL 60193              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BMT ANSCORE HEALTH MANAGEMENT SYSTEM
BOSTON MEDICAL TECHNOLOGIES, INC. 510(k) NO: K010955(SPECIAL)
ATTN: CESIDIO  TEMPESTA           PHONE NO : 781-213-9200
591 NORTH AVE., SUITE 5           SE DECISION MADE: 26-APR-01
WAKEFIELD, MA 01880-1641          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COBRA 1/2 FLEX SURGICAL PROBE, MODEL 1593X; COBRA FLEX SURGICAL
BOSTON SCIENTIFIC CORP.           510(k) NO: K010956(SPECIAL)
ATTN: ANDREA L RUTH               PHONE NO : 408-895-3625
2710 ORCHARD PARKWAY              SE DECISION MADE: 13-APR-01
SAN JOSE, CA 95134                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALIEN RX MICRO CANNULA, MODEL 4530
BOSTON SCIENTIFIC CORP.           510(k) NO: K010993(SPECIAL)
ATTN: LIAS M QUAGLIA              PHONE NO : 508-650-8267
ONE BOSTON SCIENTIFIC PLACE       SE DECISION MADE: 30-APR-01
NATICK, MA 01760                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GUIDER SOFTIP GUIDING CATHETER XF 5F
BOSTON SCIENTIFIC, TARGET         510(k) NO: K010853(SPECIAL)
ATTN: ROXANE K BAXTER             PHONE NO : 510-624-2105
47900 BAYSIDE PARKWAY             SE DECISION MADE: 18-APR-01
FREMONT, CA 94538                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UM
BUSSE HOSPITAL DISPOSABLES, INC.  510(k) NO: K010835(TRADITIONAL)
ATTN: VICKI  ATOR                 PHONE NO : 631-435-4711
75 ARKAY DR.                      SE DECISION MADE: 30-APR-01
HAUPPAUGE, NY 11788               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NIAGARA SLIM-CATH
C.R. BARD, INC.                   510(k) NO: K010778(SPECIAL)
ATTN: PEGGY  KEIFFER              PHONE NO : 801-595-0700
5425 WEST AMELIA EARHART DR.      SE DECISION MADE: 13-APR-01
SALT LAKE CITY, UT 84116          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CH 2000 CARDIAC DIAGNOSTIC SYSTEM
CAMBRIDGE HEART, INC.             510(k) NO: K010756(SPECIAL)
ATTN: JOHN  GREENBAUM             PHONE NO : 954-680-2548
20310 SW 48TH ST.                 SE DECISION MADE: 12-APR-01
FT. LAUDERDALE, FL 33332          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS
CAMBRIDGE HEART, INC.             510(k) NO: K010758(SPECIAL)
ATTN: JOHN  GREENBAUM             PHONE NO : 954-680-2548
20310 SW 48TH ST.                 SE DECISION MADE: 12-APR-01
FT. LAUDERDALE, FL 33332          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CANDELA LONG PULSE ND:YAG
CANDELA CORP.                     510(k) NO: K010104(TRADITIONAL)
ATTN: JOAN  CLIFFORD              PHONE NO : 508-358-7637
530 BOSTON POST RD.               SE DECISION MADE: 11-APR-01
WAYLAND, MA 01778                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GUIDANT AXIUS CORONARY SHUNT
CARDIOTHORACIC SYSTEMS, INC.      510(k) NO: K010117(TRADITIONAL)
ATTN: ANNE  SCHLAGENHAFT          PHONE NO : 408-366-3261
10600 NORTH TANTAU AVE.           SE DECISION MADE: 04-APR-01
CUPERTINO, CA 95014               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERSALUX
CENTRIX INC.                      510(k) NO: K010133(TRADITIONAL)
ATTN: JOHN  DISCKO                PHONE NO : 203-929-5582
770 RIVER ROAD                    SE DECISION MADE: 05-APR-01
SHELTON, CT 06484-5458            510(k) STATEMENT

DEVICE: COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT V
COBE CARDIOVASCULAR, INC.         510(k) NO: K004046(TRADITIONAL)
ATTN: LYNNE  LEONARD              PHONE NO : 303-467-6586
14401 WEST 65TH WAY               SE DECISION MADE: 26-APR-01
ARVADA, CO 80004                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPAZZ
COLOURS 'N MOTION                 510(k) NO: K010823(TRADITIONAL)
ATTN: VICTOR R BOX                PHONE NO : 714-978-1440
1591 SOUTH SINCLAIR ST.           SE DECISION MADE: 27-APR-01
ANAHEIM, CA 92806                 510(k) STATEMENT

DEVICE: REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
CORGENIX, INC.                    510(k) NO: K001352(TRADITIONAL)
ATTN: NANCI  DEXTER               PHONE NO : 303-457-4345
12061 TEJON ST.                   SE DECISION MADE: 09-APR-01
WESTMINISTER, CO 80234            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRINITY POLYAXIAL SCREW, MEHDIAN SPINAL ROD (6MM), MODEL 159.XXX
CORIN U.S.A.                      510(k) NO: K010776(SPECIAL)
ATTN: JOEL  BATTS                 PHONE NO : 813-977-4469
10500 UNIVERSITY CENTER DR.,      SE DECISION MADE: 06-APR-01
SUITE 190                         510(k) SUMMARY AVAILABLE FROM FDA
TAMPA, FL 33612

DEVICE: COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER
COULTER CORPORATION               510(k) NO: K010765(SPECIAL)
ATTN: STAN  SUGRUE                PHONE NO : 305-380-4552
651 WEST 20TH ST.                 SE DECISION MADE: 13-APR-01
HIALEAH, FL 33010                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CYNOSURE PHOTOGENICA DL
CYNOSURE, INC.                    510(k) NO: K010005(TRADITIONAL)
ATTN: GEORGE  CHO                 PHONE NO : 978-256-4200
10 ELIZABETH DR.                  SE DECISION MADE: 02-APR-01
CHELMSFORD, MA 01824              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DIMENSION CTNI FLEX REAGENT CARTRIDGE
DADE BEHRING, INC.                510(k) NO: K010313(TRADITIONAL)
ATTN: GEORGE  PLUMMER             PHONE NO : 302-631-9798
P.O. BOX 6101, BUILDING 500       SE DECISION MADE: 20-APR-01
NEWARK, DE 19714                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIMENSION CTNI CALIBRATOR
DADE BEHRING, INC.                510(k) NO: K010314(TRADITIONAL)
ATTN: GEORGE  PLUMMER             PHONE NO : 302-631-9798
P.O. BOX 6101, BUILDING 500       SE DECISION MADE: 20-APR-01
NEWARK, DE 19714                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALARMVIEW WIRELESS DATA NETWORK SYSTEM
DATA CRITICAL CORP.               510(k) NO: K010912(SPECIAL)
ATTN: TERESA  DAVIDSON            PHONE NO : 425-482-7047
19820 NORTH CREEK PKWY., #100     SE DECISION MADE: 05-APR-01
BOTHELL, WA 98011                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MOSS MIAMI 5.5MM TITANIUM PIN NUT
DEPUY ACROMED                     510(k) NO: K010742(SPECIAL)
ATTN: FRANK  MAAS                 PHONE NO : 508-828-3390
325 PARAMOUNT DR.                 SE DECISION MADE: 12-APR-01
RAYNHAM, MA 02767                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LIN
DEPUY ORTHOPAEDICS, INC.          510(k) NO: K010171(TRADITIONAL)
ATTN: ARLENE C SAULL              PHONE NO : 219-267-8143
700 ORTHOPAEDIC DR.               SE DECISION MADE: 06-APR-01
P.O. BOX 988                      510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988

DEVICE: DEPUY PRESERVATION UNICONDYLAR KNEE PROSTHESIS
DEPUY ORTHOPAEDICS, INC.          510(k) NO: K010810(SPECIAL)
ATTN: JANET G JOHNSON             PHONE NO : 219-371-4907
700 ORTHOPAEDIC DR.               SE DECISION MADE: 18-APR-01
WARSAW, IN 46581-0988             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS
DIAGNOSTIC PRODUCTS CORP.         510(k) NO: K010878(SPECIAL)
ATTN: EDWARD M LEVINE             PHONE NO : 310-645-8200
5700 WEST 96TH ST.                SE DECISION MADE: 18-APR-01
LOS ANGELES, CA 90045             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STA-QUALITY HBPM/LMWH KIT
DIAGNOSTICA STAGO, INC.           510(k) NO: K010324(TRADITIONAL)
ATTN: ANDREW  LOC B. LE           PHONE NO : 973-631-1200
5 CENTURY DR.                     SE DECISION MADE: 09-APR-01
PARSIPPANY, NJ 07054              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STA -CALIBRATOR HBPM/LMWH KIT
DIAGNOSTICA STAGO, INC.           510(k) NO: K010350(TRADITIONAL)
ATTN: ANDREW  LOC B. LE           PHONE NO : 973-631-1200
5 CENTURY DR.                     SE DECISION MADE: 09-APR-01
PARSIPPANY, NJ 07054              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SAFESTING AND SAFESTING HUB
DIASOL INC.                       510(k) NO: K011003(TRADITIONAL)
ATTN: MONICA  ABELES              PHONE NO : 818-255-1800
13212 RAYMER ST.                  SE DECISION MADE: 20-APR-01
NORTH HOLLYWOOD, CA 91605         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAMMOGRAPH
DIGITEC MEDICAL SERVICE CORPORATIO510(k) NO: K010792(TRADITIONAL)
ATTN: JAMES J MCGINTY             PHONE NO : 770-995-0050
465 MALTBIE STREET                SE DECISION MADE: 03-APR-01
SUITE 407                         510(k) SUMMARY AVAILABLE FROM FDA
LAWRENCEVILLE, GA 30045

DEVICE: FLO-BOOT
DISCOVERY GROUP LLC               510(k) NO: K003272(TRADITIONAL)
ATTN: RICHARD J FREER             PHONE NO : 804-285-7034
8110 WESTBURY DR.                 SE DECISION MADE: 04-APR-01
RICHMOND, VA 23229                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DORNIER COMPACT ALPHA LITHOTRIPTER
DORNIER MEDICAL SYSTEMS, INC.     510(k) NO: K002929(TRADITIONAL)
ATTN: CAROL  WERNECKE             PHONE NO : 770-514-6206
1155 ROBERTS BLVD.                SE DECISION MADE: 17-APR-01
KENNESAW, GA 30144                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATAC PAK AST REAGENT KIT
ELAN HOLDINGS, INC.               510(k) NO: K010488(TRADITIONAL)
ATTN: WYNN  STOCKING              PHONE NO : 714-672-3553
231 NORTH PUENTE ST.              SE DECISION MADE: 09-APR-01
BREA, CA 92821                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIPOLAR TRIGGER-FLEX PROBE
ELLMAN INTL., INC.                510(k) NO: K003126(TRADITIONAL)
ATTN: FRANK  LIN                  PHONE NO : 516-569-1482
1135 RAILROAD AVENUE              SE DECISION MADE: 11-APR-01
HEWLETT, NY 11557-2316            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMBOL-X INTRODUCER, MODEL CF00200
EMBOL-X, INC.                     510(k) NO: K002973(TRADITIONAL)
ATTN: ED  LEE                     PHONE NO : 650-390-0280
645 CLYDE AVE.                    SE DECISION MADE: 26-APR-01
MOUNTAIN VIEW, CA 94043           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIPOLAR COAGULATION SYSTEM
ENABLE MEDICAL CORP.              510(k) NO: K010112(TRADITIONAL)
ATTN: MARK L FRIEDMAN             PHONE NO : 513-755-7600
6345 CENTRE PARK DR.              SE DECISION MADE: 02-APR-01
WEST CHESTER, OH 45069-3863       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODEL LCSC5,LCS
ETHICON ENDO-SURGERY, INC.        510(k) NO: K002981(TRADITIONAL)
ATTN: RUTH A WOOD                 PHONE NO : 513-337-3468
4545 CREEK RD.                    SE DECISION MADE: 09-APR-01
CINCINNATI, OH 45242-2839         510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGIC
ETHICON, INC.                     510(k) NO: K010722(TRADITIONAL)
ATTN: GREGORY R JONES             PHONE NO : 908-218-2481
P.O. BOX 151                      SE DECISION MADE: 27-APR-01
SOMERVILLE, NJ 08876-0151         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUMATCH M-SERIES EXTRA-SMALL METAPHYSEAL SEGMENTS
EXACTECH, INC.                    510(k) NO: K011081(SPECIAL)
ATTN: GARY J MILLER               PHONE NO : 352-377-1140
2320 N.W. 66TH CT.                SE DECISION MADE: 24-APR-01
GAINESVILLE, FL 32653             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED)
EXCEL TECH. LTD.                  510(k) NO: K010086(TRADITIONAL)
ATTN: SONJA  MARKEZ               PHONE NO : 905 829 5300
2568 BRISTOL CIRCLE               SE DECISION MADE: 09-APR-01
OAKVILLE, ONTARIO, CANADA L6H  5S1510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROP
EXCEL TECH. LTD.                  510(k) NO: K010092(TRADITIONAL)
ATTN: SONJA  MARKEZ               PHONE NO : 905 829 5300
2568 BRISTOL CIRCLE               SE DECISION MADE: 02-APR-01
OAKVILLE, ONTARIO, CANADA L6H  5S1510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INSTACHECK MULTI-DRUG THC/COC, MOR 300/MET/MTD, AMP/BAR/BZO TEST
FOREFRONT DIAGNOSTICS, INC.       510(k) NO: K003546(TRADITIONAL)
ATTN: FENG-YU  LEE                PHONE NO : 949-595-0673
23561 RIDGE ROUTE DR., SUITE D    SE DECISION MADE: 05-APR-01
LAGUNA HILLS, CA 92653            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FRSENIUS PD IQCARD CYCLER
FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K002892(TRADITIONAL)
ATTN: ARTHUR  EILINSFEILD         PHONE NO : 781-402-9068
95 HAYDEN AVENUE                  SE DECISION MADE: 05-APR-01
LEXINGTON, MA 02420               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9
FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K010268(TRADITIONAL)
ATTN: ARTHUR  EILINSFELD          PHONE NO : 781-402-9068
95 HAYDEN AVE.                    SE DECISION MADE: 27-APR-01
LEXINGTON, MA 02173               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FUNET AMY MAMA BODY THERMOMETER
FUNAI RADIO & COMMUNICATIONS CORP.510(k) NO: K003326(TRADITIONAL)
ATTN: JOHN  LIN                   PHONE NO : 886 453 41984
3F, NO. 24 CHIEN KUO RD.          SE DECISION MADE: 11-APR-01
T.E.P.Z. TANTZU                   510(k) STATEMENT
TAICHUNG, CHINA (TAIWAN) 427

DEVICE: FIESTA IMAGING OPTION
GE MEDICAL SYSTEM                 510(k) NO: K002997(TRADITIONAL)
ATTN: LARRY A KROGER              PHONE NO : 262-544-3894
3200 N. GRANDVIEW BLVD.           SE DECISION MADE: 11-APR-01
WAUKESHA, WI 53188                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: 3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL
GE MEDICAL SYSTEMS                510(k) NO: K003613(TRADITIONAL)
ATTN: LARRY A KROGER              PHONE NO : 262-544-3894
P.O. BOX 414, W-709               SE DECISION MADE: 03-APR-01
MILWAUKEE, WI 53201               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ICG MODULE
GENERAL ELECTRIC MEDICAL SYSTEMS I510(k) NO: K010164(TRADITIONAL)
ATTN: KAREN  WEBB                 PHONE NO : 414-362-3329
8200 WEST TOWER AVE.              SE DECISION MADE: 09-APR-01
MILWAUKEE, WI 53223               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE ELASTIC VINYL EXAMINATION GLOVES
GENERAL GLOVES CORP.              510(k) NO: K010829(TRADITIONAL)
ATTN: JOHN  CHEN                  PHONE NO : 886 668 03675
25 PEI MA, 16 LIN TUNG CHUNG      SE DECISION MADE: 05-APR-01
VILLAGE, TUNG SHAN HSIANG         510(k) STATEMENT
TAINAN HSIEN, CHINA (TAIWAN) 733

DEVICE: POWDER FREE TEXTURED VINYL EXAMINATION GLOVES
GENERAL GLOVES CORP.              510(k) NO: K010830(TRADITIONAL)
ATTN: JOHN  CHEN                  PHONE NO : 886 668 03675
25 PEI MA, 16 LIN TUNG CHUNG      SE DECISION MADE: 09-APR-01
VILLAGE, TUNG SHAN HSIANG         510(k) STATEMENT
TAINAN HSIEN, CHINA (TAIWAN) 733

DEVICE: MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT
GIBBONS SURGICAL CORPORATION      510(k) NO: K010779(SPECIAL)
ATTN: LISA  CRISSON               PHONE NO : 757-491-7305
1112 JENSEN DRIVE, STE.101        SE DECISION MADE: 10-APR-01
VIRGINIA BEACH, VA 23451          510(k) STATEMENT

DEVICE: ENT ENDOSCOPES
GLOBAL ENDOSCOPY, INC.            510(k) NO: K003830(TRADITIONAL)
ATTN: NICK  MIRCEA                PHONE NO : 888-434-3398
914 W. ESTES CT.                  SE DECISION MADE: 09-APR-01
SCHAUMBURG, IL 60193-4426         510(k) STATEMENT

DEVICE: VACUETTE SPEEDY QUICK-RELEASE HOLDER
GREINER VACUETTE NORTH AMERICA, IN510(k) NO: K003812(TRADITIONAL)
ATTN: JUDI  SMITH                 PHONE NO : 410-313-8003
P.O. BOX 6581                     SE DECISION MADE: 30-APR-01
ELLICOTT CITY, MD 21042-0581      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RX HERCULINK PLUS BILIARY STENT SYSTEM
GUIDANT CORP.                     510(k) NO: K010684(SPECIAL)
ATTN: BYRON  LAMBERT              PHONE NO : 909-914-2156
26531 YNEZ RD.                    SE DECISION MADE: 12-APR-01
TEMECULA, CA 92591                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AB CARDIETTE START 200 HV
H&C MEDICAL DEVICES SPA           510(k) NO: K010822(SPECIAL)
ATTN: ATTILIO  CASTELLI           PHONE NO : 390 222 476861
VIA PISA 250                      SE DECISION MADE: 18-APR-01
20099 SESTO SAN GIOVANNI          510(k) SUMMARY AVAILABLE FROM FDA
MILAN, ITALY
 
DEVICE: HARDYDISK BACITRACIN, 10MCG, MODEL Z927
HARDY DIAGNOSTICS                 510(k) NO: K011086(TRADITIONAL)
ATTN: MELISSA M TRAYLOR           PHONE NO : 805-346-2766
1430 WEST MCCOY LANE              SE DECISION MADE: 26-APR-01
SANTA MARIA, CA 93455             510(k) STATEMENT

DEVICE: LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES
HORIZON MEDICAL PRODUCTS, INC.    510(k) NO: K010767(SPECIAL)
ATTN: PENNY M NORTHCUTT           PHONE NO : 706-846-3126
1 HORIZON WAY                     SE DECISION MADE: 10-APR-01
MANCHESTER, GA 31816              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COBE HC 700 MIDI HEMOCONCENTRATOR
HOSPAL INDUSTRIE                  510(k) NO: K003023(TRADITIONAL)
ATTN: BARBARA A WATSON            PHONE NO : 303-467-6018
14401 W. 65TH WAY                 SE DECISION MADE: 30-APR-01
ARVADA, CO 80004-3599             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REFLEX ANTERIOR CERVICAL PLATE SYSTEM
HOWMEDICA OSTEONICS CORP.         510(k) NO: K010115(TRADITIONAL)
ATTN: KAREN  ARIEMMA              PHONE NO : 201-760-8187
59 ROUTE 17                       SE DECISION MADE: 16-APR-01
ALLENDALE, NJ 07401-1677          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRIDENT POROUS TITANIUM ACETABULAR COMPONENT
HOWMEDICA OSTEONICS CORP.         510(k) NO: K010170(TRADITIONAL)
ATTN: MARGARET F CROWE            PHONE NO : 201-934-4359
59 ROUTE 17                       SE DECISION MADE: 18-APR-01
ALLENDALE, NJ 07401-1677          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LFIT V40 FEMORAL HEAD COMPONENTS
HOWMEDICA OSTEONICS CORP.         510(k) NO: K010757(SPECIAL)
ATTN: JENNIFER A DAUDELIN         PHONE NO : 201-934-4354
59 ROUTE 17                       SE DECISION MADE: 11-APR-01
ALLENDALE, NJ 07401-1677          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: T2 FEMORAL NAIL
HOWMEDICA OSTEONICS CORP.         510(k) NO: K010801(SPECIAL)
ATTN: KAREN  ARIEMMA              PHONE NO : 201-825-4900
59 ROUTE 17                       SE DECISION MADE: 06-APR-01
ALLENDALE, NJ 07401-1677          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO OSTEONICS SPINAL SYSTEM
HOWMEDICA OSTEONICS CORP.         510(k) NO: K010845(SPECIAL)
ATTN: KAREN  ARIEMMA              PHONE NO : 201-760-8187
59 ROUTE 17                       SE DECISION MADE: 18-APR-01
ALLENDALE, NJ 07401-1677          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BABY DOPPLEX 3000 MK 2 (BD3000)
HUNTLEIGH HEALTHCARE, INC.        510(k) NO: K010889(SPECIAL)
ATTN: B.J.  COLLEYPRIEST          PHONE NO : 800-223-1218
35 PORTMANMOOR ROAD               SE DECISION MADE: 25-APR-01
CARDIFF, UNITED KINGDOM CF24 5HN  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BABY DOPPLEX 3002 (BD3002)
HUNTLEIGH HEALTHCARE, INC.        510(k) NO: K010894(SPECIAL)
ATTN: B.J.  COLLEYPRIEST          PHONE NO : 800-223-1218
35 PORTMANMOOR ROAD               SE DECISION MADE: 25-APR-01
CARDIFF, UNITED KINGDOM CF24 5HN  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPERMICIDAL LUBRICATED MALE LATEX CONDOM
INNOLATEX SDN. BHD                510(k) NO: K010178(ABBREVIATED)
ATTN: CHANG  AU-KAU               PHONE NO : 603 747 2434
NO. 16, JALAN BULAN U5/5,         SE DECISION MADE: 27-APR-01
BANDAR PINGGIRAN SUBANG           510(k) STATEMENT
SHAH ALAM, SELANGOR D.E., MALAYSIA 40150

DEVICE: QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA
INOVA DIAGNOSTICS, INC.           510(k) NO: K010558(TRADITIONAL)
ATTN: BRYS C MYERS                PHONE NO : 858-586-9900
10180 SCRIPPS RANCH BLVD.         SE DECISION MADE: 03-APR-01
SAN DIEGO, CA 92131               510(k) STATEMENT

DEVICE: IL TEST FREE PROTEIN S
INSTRUMENTATION LABORATORY CO.    510(k) NO: K010379(TRADITIONAL)
ATTN: CAROL  MARBLE               PHONE NO : 781-861-4467
113 HARTWELL AVE.                 SE DECISION MADE: 13-APR-01
LEXINGTON, MA 02421               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XTRACTOR, MODEL M143
INSTRUMENTS MEDICAUX G.B. INC.    510(k) NO: K010220(TRADITIONAL)
ATTN: MARTIN  PAQUETTE            PHONE NO : 819 820 8404
REGULATORY AFFAIRS                SE DECISION MADE: 09-APR-01
411 BELVEDERE SUD                 510(k) SUMMARY AVAILABLE FROM FDA
SHERBROOKE, QUEBEC, CANADA

DEVICE: APPLICATOR TIP/DUAL SPRAYER KIT
INTERPORE CROSS INTL.             510(k) NO: K010708(TRADITIONAL)
ATTN: LYNN M RODARTI              PHONE NO : 949-453-3200
181 TECHNOLOGY DR.                SE DECISION MADE: 30-APR-01
IRVINE, CA 92618-2402             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ILT DEFLECTING CATHETER, MODEL C114ND1
INTRALUMINAL THERAPEUTICS, INC.   510(k) NO: K010531(SPECIAL)
ATTN: PAMELA  MISAJON             PHONE NO : 760-918-1820
6354 CORTE DEL ABETO              SE DECISION MADE: 18-APR-01
SUITE A                           510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92009

DEVICE: INVACARE PASSOVER HUMIDIFIER MODEL ISP9700
INVACARE CORP.                    510(k) NO: K003561(TRADITIONAL)
ATTN: RAE ANN  FARROW             PHONE NO : 440-329-6356
ONE INVACARE WAY                  SE DECISION MADE: 17-APR-01
ELYRIA, OH 44036-2125             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNPLUG
ISOTIS BV                         510(k) NO: K010840(SPECIAL)
ATTN: CYNTHIA J M. NOLTE          PHONE NO : 919-859-4207
49 PLAIN STREET                   SE DECISION MADE: 20-APR-01
NORTH ATTLEBORO, MA 02760         510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MULTIPLE (IZON DNA BLOOD COLLECTION KIT)
IZON BUSINESS PRODUCTS, INC.      510(k) NO: K010328(TRADITIONAL)
ATTN: JACK  WERTZ                 PHONE NO : 845-353-6767
520 WEST NYACK RD.                SE DECISION MADE: 09-APR-01
WEST NYACK, NY 10994              510(k) STATEMENT

DEVICE: ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTE
JOHNSON & JOHNSON VISION CARE, INC510(k) NO: K010114(TRADITIONAL)
ATTN: SHARON  BRIGGS              PHONE NO : 904-443-1471
7500 CENTURION PKWY.              SE DECISION MADE: 11-APR-01
JACKSONVILLE, FL 32256            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUM
KARL STORZ ENDOSCOPY              510(k) NO: K010569(TRADITIONAL)
ATTN: JAMES A LEE                 PHONE NO : 800-421-0837
600 CORPORATE POINTE              SE DECISION MADE: 09-APR-01
CULVER CITY, CA 90230-7600        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K003994(TRADITIONAL)
ATTN: JAMES A LEE                 PHONE NO : 310-410-2769
600 CORPORATE POINTE              SE DECISION MADE: 13-APR-01
CULVER CITY, CA 90230-7600        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM
KARL STORZ IMAGING, INC.          510(k) NO: K003325(TRADITIONAL)
ATTN: TERRY  FERNANDEZ            PHONE NO : 805-968-5563
175 CREMONA DR.                   SE DECISION MADE: 27-APR-01
GOLETA, CA 93117                  510(k) STATEMENT

DEVICE: TAKE ONE BITE MODIFIED
KERR CORP.                        510(k) NO: K010994(TRADITIONAL)
ATTN: COLLEEN  BOSWELL            PHONE NO : 714-516-7484
1717 WEST COLLINS AVE.            SE DECISION MADE: 23-APR-01
ORANGE, CA 92867                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PJUR EROS WATER FORMULATION
L.C.C. PJUR GROUP GERMANY         510(k) NO: K010199(TRADITIONAL)
ATTN: RICHARD  HARRIS             PHONE NO : 212-337-3767
65 BANK STREET                    SE DECISION MADE: 05-APR-01
SUITE #9                          510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10014

DEVICE: LAGLOVE BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (GR
LAGLOVE (M) SDN. BHD.             510(k) NO: K010860(TRADITIONAL)
ATTN: G  BASKARAN                 PHONE NO : 603 873 35411
LOT 478, JALAN SIMPANG BALAK,     SE DECISION MADE: 03-APR-01
OFF BATU 13, JALAN CHERAS         510(k) STATEMENT
KAJANG, SELANGOR, D.E., MALAYSIA 43000

DEVICE: LAGLOVE BRAND COLORED POWDERED NITRILE EXAMINATION GLOVES(GREEN/
LAGLOVE (M) SDN. BHD.             510(k) NO: K010861(TRADITIONAL)
ATTN: G  BASKARAN                 PHONE NO : 603 873 35411
LOT 478, JALAN SIMPANG BALAK,     SE DECISION MADE: 03-APR-01
OFF BATU 13, JALAN CHERAS         510(k) STATEMENT
KAJANG, SELANGOR, D.E., MALAYSIA 43000
 
DEVICE: LASER MECHANISMS LASER SCANNING SYSTEM
LASER MECHANISMS, INC.            510(k) NO: K010113(TRADITIONAL)
ATTN: JEFFREY  HOCKING            PHONE NO : 248-474-9480
P.O. BOX 2064                     SE DECISION MADE: 12-APR-01
SOUTHFIELD, MI 48037, MI 48037    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE LIBERATOR WHEELCHAIR
LIBERATOR WHEELCHAIRS, INC.       510(k) NO: K010859(SPECIAL)
ATTN: RICARDO  KAUFMANN           PHONE NO : 817-831-3707
3402-B N. BEACH ST.               SE DECISION MADE: 05-APR-01
HALTON CITY, TX 76111             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES P
LSI SOLUTIONS                     510(k) NO: K011016(SPECIAL)
ATTN: CHRISTINE E EHMANN          PHONE NO : 716-427-7979
2144 BRIGHTON-HENRIETTA TOWN      SE DECISION MADE: 27-APR-01
LINE RD.                          510(k) SUMMARY AVAILABLE FROM FDA
ROCHESTER, NY 14623

DEVICE: MAGNUM
MAGNUM EQUIPMENT L.L.C.           510(k) NO: K010252(TRADITIONAL)
ATTN: MONTE  REGAL                PHONE NO : 405-789-7171
7222 W. MELROSE LANE              SE DECISION MADE: 26-APR-01
OKLAHOMA CITY, OK 73127           510(k) STATEMENT

DEVICE: UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450
MARINA MEDICAL INSTRUMENTS, INC.  510(k) NO: K010296(TRADITIONAL)
ATTN: JIHAD (JAY)  MANSOUR        PHONE NO : 954-924-4418
2761 N 29TH AVE                   SE DECISION MADE: 11-APR-01
HOLLYWOOD, FL 33020               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISPO-MED 7.6 LITER SHARPS CONTAINER
MASTER BENEFITS INC.              510(k) NO: K003521(TRADITIONAL)
ATTN: JOHNNY  TABOADA             PHONE NO : 510-780-0819
2622 HAWTHORNE AVE                SE DECISION MADE: 19-APR-01
HAYWARD, CA 94545                 510(k) STATEMENT

DEVICE: DOSIMETRY CHECK
MATH RESOLUTIONS, LLC             510(k) NO: K010225(TRADITIONAL)
ATTN: WENDEL D RENNER             PHONE NO : 410-997-9578
5975 GALES LANE                   SE DECISION MADE: 24-APR-01
COLUMBIA, MD 21045                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MED-LOGICS DISPOSABLE ALK TUBING
MED-LOGICS, INC.                  510(k) NO: K010353(TRADITIONAL)
ATTN: GARY  MOCNIK                PHONE NO : 949-363-2953
2788 LAPAZ RD. #G-316             SE DECISION MADE: 27-APR-01
LAGUNA NIGUEL,, CA 92677          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ECHOSEED/IODINE-125 SEEDS, MODEL 6733
MEDI-PHYSICS INC. DBA NYCOMED AMER510(k) NO: K010821(SPECIAL)
ATTN: SUBHASH  PATEL              PHONE NO : 609-514-6846
3350 RIDGE AVE.                   SE DECISION MADE: 11-APR-01
ARLINGTON HEIGHTS, IL 60004       510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MODEL 455GE PHASED ARRAY WRIST COIL
MEDICAL ADVANCES, INC.            510(k) NO: K010074(TRADITIONAL)
ATTN: MICHAEL  LEIGH              PHONE NO : 414-258-3808
10437 INNOVATION DR.              SE DECISION MADE: 03-APR-01
MILWAUKEE, WI 53226               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,
MEDICAL CONCEPTS DEVELOPMENT, INC.510(k) NO: K000442(TRADITIONAL)
ATTN: DAVID  PADGET               PHONE NO : 651-702-5103
2500 VENTURA DR.                  SE DECISION MADE: 24-APR-01
WOODBURY, MN 55125-3927           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPTIMA
MEDICAL INDUSTRIES AMERICA, INC.  510(k) NO: K011053(TRADITIONAL)
ATTN: LEE  SMITH                  PHONE NO : 515-993-5001
2636 289TH PLACE                  SE DECISION MADE: 20-APR-01
ADEL, IA 50003-8021               510(k) STATEMENT
                                  THIRD PARTY REVIEW

DEVICE: MEDIFACE PACS
MEDIFACE CO., LTD.                510(k) NO: K010259(TRADITIONAL)
ATTN: CARL  PERSON                PHONE NO : 940-440-9330
2001 EAST OAKSHORES DRIVE         SE DECISION MADE: 26-APR-01
CROSSROADS, TX 76227              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STS-T LITHOTRIPTER, MODEL STS-T
MEDSTONE INTL., INC.              510(k) NO: K010900(SPECIAL)
ATTN: RONALD  BERGESON            PHONE NO : 949-448-7700
100 COLUMBIA, SUITE 100           SE DECISION MADE: 05-APR-01
ALISO VIEJO, CA 92656-4114        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERDICT -II BAR/BZO
MEDTOX DIAGNOSTICS, INC.          510(k) NO: K010561(SPECIAL)
ATTN: MICHAEL  TURANCHIK          PHONE NO : 336-226-6311
1238 ANTHONY RD.                  SE DECISION MADE: 05-APR-01
BURLINGTON, NC 27215              510(k) STATEMENT

DEVICE: VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO; PROFI
MEDTOX DIAGNOSTICS, INC.          510(k) NO: K010564(SPECIAL)
ATTN: MICHAEL  TURANCHIK          PHONE NO : 336-226-6311
1238 ANTHONY RD.                  SE DECISION MADE: 05-APR-01
BURLINGTON, NC 27215              510(k) STATEMENT

DEVICE: VERDICT -II BAR; VERDICT -II BZO
MEDTOX DIAGNOSTICS, INC.          510(k) NO: K010959(SPECIAL)
ATTN: MICHAEL  TURANCHIK          PHONE NO : 336-226-6311
1238 ANTHONY RD.                  SE DECISION MADE: 13-APR-01
BURLINGTON, NC 27215              510(k) STATEMENT

DEVICE: SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL
MEDTRONIC CARDIAC SURGICAL PRODUCT510(k) NO: K010737(SPECIAL)
ATTN: MARIE  HOLM                 PHONE NO : 763-391-9183
7611 NORTHLAND DRIVE              SE DECISION MADE: 04-APR-01
MINNEAPOLIS, MN 55428             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-
MEDTRONIC PS MEDICAL              510(k) NO: K010341(ABBREVIATED)
ATTN: JANET  MCAULEY              PHONE NO : 805-968-1546
125 CREMONA DR.,                  SE DECISION MADE: 20-APR-01
UNIVERSITY BUSINESS CENTER        510(k) SUMMARY AVAILABLE FROM FDA
GOLETA, CA 93117

DEVICE: TSRH SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK           510(k) NO: K010720(SPECIAL)
ATTN: RICHARD W TREHARNE          PHONE NO : 800-876-3133
1800 PYRAMID PLACE                SE DECISION MADE: 11-APR-01
MEMPHIS, TN 38132                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K010529(SPECIAL)
ATTN: RICHARD W TREHARNE          PHONE NO : 901-396-3133
1800 PYRAMID PLACE                SE DECISION MADE: 27-APR-01
MEMPHIS, TN 38132                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254
MEDTRONIC, INC.                   510(k) NO: K010906(TRADITIONAL)
ATTN: KAREN  CLEMENT              PHONE NO : 763-514-9933
4000 LEXINGTON AVE. N             SE DECISION MADE: 05-APR-01
SHOREVIEW, MN 55126-2983          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MENTOR STERILE SALINE MAMMARY VOLUME SIZERS
MENTOR CORP.                      510(k) NO: K010709(TRADITIONAL)
ATTN: DONNA  CRAWFORD             PHONE NO : 805-879-6304
201 MENTOR DRIVE                  SE DECISION MADE: 23-APR-01
SANTA BARBARA, CA 93111           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385
MINIMED INC.                      510(k) NO: K010377(TRADITIONAL)
ATTN: JENNIFER  LYONS             PHONE NO : 818-362-5958
18000 DEVONSHIRE ST.              SE DECISION MADE: 05-APR-01
NORTHRIDGE, CA 91325              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BREAST IMMOBIIZATION AND BIOPSY DEVICE MR-BIOPSY 160
MRI DEVICES CORP.                 510(k) NO: K010570(TRADITIONAL)
ATTN: THOMAS  SCHUBERT            PHONE NO : 262-524-1402
1515 PARAMOUNT DRIVE              SE DECISION MADE: 09-APR-01
WAUKESHA, WI 53186                510(k) STATEMENT

DEVICE: SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR
MUTOH AMERICA CO., LTD.           510(k) NO: K010309(TRADITIONAL)
ATTN: DANIEL]  KAMM               PHONE NO : 847-374-1727
PO BOX 7007                       SE DECISION MADE: 18-APR-01
DEERFIELD, IL 60015               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET
MYCO MEDICAL SUPPLIES, INC.       510(k) NO: K000592(TRADITIONAL)
ATTN: SANJIV  KUMAR               PHONE NO : 919-678-0680
101 ROSE VALLEY WOODS DR.         SE DECISION MADE: 12-APR-01
CARY, NC 27513                    510(k) STATEMENT
 
DEVICE: PERIFORM PERINEOMETRIC PROBE, MODEL 8300
NEEN DESIGN LTD.                  510(k) NO: K002617(TRADITIONAL)
ATTN: MARK  READ                  PHONE NO : 440 136 2698966
OLD PHARMACY YARD, CHURCH ST.     SE DECISION MADE: 05-APR-01
DEREHAM, NORFOLK, UNITED KINGDOM N510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PNS MAGNETIC STIMULATOR SYSTEM
NEOTONUS, INC.                    510(k) NO: K002889(TRADITIONAL)
ATTN: SHEILA  HEMEON-HEYER        PHONE NO : 508-643-0434
49 PLAIN STREET                   SE DECISION MADE: 06-APR-01
NORTH ATTLEBORO, MA 02760         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTO
NIPRO MEDICAL CORP.               510(k) NO: K010264(TRADITIONAL)
ATTN: RICHARD D BLISS, JR         PHONE NO : 954-385-1690
510 STONEMONT DRIVE               SE DECISION MADE: 27-APR-01
WEST, FL 33326                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NOVAMETRIX MARQUETTE COMPATIBLE SENSORS
NOVAMETRIX MEDICAL SYSTEMS, INC.  510(k) NO: K010451(ABBREVIATED)
ATTN: ROBERT H SCHIFFMAN, R.A.C.  PHONE NO : 203-265-7701
56 CARPENTER LANE                 SE DECISION MADE: 25-APR-01
WALLINGFORD, CT 06492             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304
NUCLEAR ASSOC., DIV. INOVISION LP 510(k) NO: K010417(TRADITIONAL)
ATTN: CHRISTINE G CASTLEBERRY     PHONE NO : 516-741-6360
100 VOICE RD.                     SE DECISION MADE: 26-APR-01
CARLE PLACE, NY 11514             510(k) STATEMENT

DEVICE: PLATO SRS STEREOTACTIC RADIOSURGERY PLANNING SYSTEM,MODEL 2.0, P
NUCLETRON CORPORATION             510(k) NO: K010784(SPECIAL)
ATTN: ROBERT  APPLEBAUM           PHONE NO : 410-312-4100
7080 COLUMBIA GATEWAY DRIVE       SE DECISION MADE: 10-APR-01
COLUMBIA, MD 21046                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NUMED HIGH PRESSURE PTA CATHETERS
NUMED, INC.                       510(k) NO: K010880(SPECIAL)
ATTN: NICHELLE R LAFLESH          PHONE NO : 315-328-4491
2880 MAIN ST.                     SE DECISION MADE: 20-APR-01
HOPKINTON, NY 12965               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAPNOPROBE SL, MODEL 2000
OPTICAL SENSORS, INC.             510(k) NO: K010795(SPECIAL)
ATTN: GARY  SYRING                PHONE NO : 608-877-2635
800 LENANGER LANE                 SE DECISION MADE: 11-APR-01
STOUGHTON, WI 53589               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORIGEN BLADDER HOLDER
ORIGEN BIOMEDICAL, INC.           510(k) NO: K003145(TRADITIONAL)
ATTN: RICHARD  MARTIN             PHONE NO : 512-474-7278
2525 HARTFORD RD.                 SE DECISION MADE: 20-APR-01
AUSTIN, TX 78703-2428             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CRANIAL MOLDING ORTHOSIS
ORTHOTIC SOLUTIONS, INC.          510(k) NO: K010273(TRADITIONAL)
ATTN: JOSEPH F TERPENNING         PHONE NO : 703-849-9200
2802 MERRILEE DRIVE               SE DECISION MADE: 25-APR-01
SUITE 100                         510(k) SUMMARY AVAILABLE FROM FDA
FAIRFAX, VA 22031

DEVICE: OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND D
OSI MEDICAL, INC.                 510(k) NO: K002036(TRADITIONAL)
ATTN: JAMES R LEVANI              PHONE NO : 813-818-7488
13801 MCCORMICK DRIVE             SE DECISION MADE: 17-APR-01
TAMPA, FL 33626                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TCOYF FERTILITY SOFTWARE VERSION 1.0
OVUSOFT, INC.                     510(k) NO: K002726(TRADITIONAL)
ATTN: GENE  GRANT                 PHONE NO : 757-851-2225
402 DUNHAM MASSIE DRIVE           SE DECISION MADE: 06-APR-01
HAMPTON, VA 23669-1744            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SONICAID SYSTEM 8002
OXFORD INSTRUMENTS MEDICAL SYSTEMS510(k) NO: K992607(TRADITIONAL)
ATTN: E.J.  SMITH                 PHONE NO : 410-451-0639
P.O. BOX 4341                     SE DECISION MADE: 27-APR-01
CROFTON, MD 21114                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
OXOID, LTD.                       510(k) NO: K010536(TRADITIONAL)
ATTN: AMANDA  SHEPPARD            PHONE NO : 44 125 6841144
WADE ROAD                         SE DECISION MADE: 24-APR-01
BASINGSTOKE,HANTS, UNITED KINGDOM 510(k) STATEMENT

DEVICE: LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
OXOID, LTD.                       510(k) NO: K010537(TRADITIONAL)
ATTN: AMANDA  SHEPPARD            PHONE NO : 44 125 6841144
WADE ROAD                         SE DECISION MADE: 24-APR-01
BASINGSTOKE,HANTS, UNITED KINGDOM 510(k) STATEMENT

DEVICE: HEALTH-PLUS, SANITEX, RELIANCE MULTIPLY POWDER FREE POLYMER AND
PAMITEX INDUSTRIES SDN BHD        510(k) NO: K003350(TRADITIONAL)
ATTN: SAID  AWANG                 PHONE NO : 011 606 6313122
BATU 2 1/2, JALAN RASAH           SE DECISION MADE: 05-APR-01
SEREMBAN, N.S., MALAYSIA 70300    510(k) STATEMENT

DEVICE: LIVESURE COCAINE SCREEN TEST
PAN PROBE BIOTECH, INC.           510(k) NO: K010967(TRADITIONAL)
ATTN: ALICE H YU                  PHONE NO : 858-689-9936
8515 ARJONS DR., SUITE A          SE DECISION MADE: 17-APR-01
SAN DIEGO, CA 92126               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: LIVESURE MORPHINE SCREEN TEST
PAN PROBE BIOTECH, INC.           510(k) NO: K011011(TRADITIONAL)
ATTN: ALICE H YU                  PHONE NO : 858-689-9936
8515 ARJONS DR., SUITE A          SE DECISION MADE: 13-APR-01
SAN DIEGO, CA 92126               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: PASCO MIC AND MIC/ID PANELS
PASCO LABORATORIES, INC.          510(k) NO: K010508(TRADITIONAL)
ATTN: LINDA K DILLON              PHONE NO : 303-321-9813
12750 WEST 42ND AVE.              SE DECISION MADE: 23-APR-01
WHEAT RIDGE, CO 80033             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST
PASCO LABORATORIES, INC.          510(k) NO: K011116(TRADITIONAL)
ATTN: LINDA  DILLON               PHONE NO : 303-423-9504
12750 W. 42ND AVE                 SE DECISION MADE: 24-APR-01
WHEAT BRIDGE, CO 80033            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FG-36UX, FIBER ULTRASOUND GASTROSCOPE
PENTAX PRECISION INSTRUMENT CORP. 510(k) NO: K010740(TRADITIONAL)
ATTN: PAUL  SILVA                 PHONE NO : 845-365-0700
30 RAMLAND RD.                    SE DECISION MADE: 17-APR-01
ORANGEBURG, NY 10962              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHO CONTROL FEMALE URINARY CONTROL DEVICE
PERSONAL PRODUCTS CO.             510(k) NO: K010365(TRADITIONAL)
ATTN: MARYLOU  PANICO             PHONE NO : 908-904-3709
199 GRANDVIEW RD.                 SE DECISION MADE: 30-APR-01
SKILLMAN, NJ 08558                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, PURPLE COLOR
PERUSAHAAN GETAH ASAS SDN BHD     510(k) NO: K010719(TRADITIONAL)
ATTN: KONG C TAN                  PHONE NO : 603 329 11949
LOT 754, JALAN HAJI SIRAT         SE DECISION MADE: 10-APR-01
OFF JALAN KAPAR, PO BOX 188       510(k) STATEMENT
SELANGOR DARUL EHSAN, MALAYSIA 41720

DEVICE: AT HOME DRUG TEST, MODEL 9068 T
PHAMATECH                         510(k) NO: K010653(SPECIAL)
ATTN: CARL A MONGIOVI             PHONE NO : 858-635-5840
9530 PADGETT STREET #101          SE DECISION MADE: 05-APR-01
SAN DIEGO, CA 92126               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AT HOME DRUG TEST, MODEL 9078 T
PHAMATECH                         510(k) NO: K010654(SPECIAL)
ATTN: CARL A MONGIOVI             PHONE NO : 858-635-5840
9530 PADGETT STREET #101          SE DECISION MADE: 05-APR-01
SAN DIEGO, CA 92126               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AT HOME DRUG TESTT, MODEL 9150 T
PHAMATECH                         510(k) NO: K010655(SPECIAL)
ATTN: CARL A MONGIOVI             PHONE NO : 858-635-5840
9530 PADGETT STREET #101          SE DECISION MADE: 05-APR-01
SAN DIEGO, CA 92126               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AT WORK DRUG TEST, MODEL 9177T AWT
PHAMATECH                         510(k) NO: K010833(SPECIAL)
ATTN: CARL A MONGIOVI             PHONE NO : 858-635-5840
9530 PADGETT STREET #101          SE DECISION MADE: 11-APR-01
SAN DIEGO, CA 92126               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AT WORK DRUG TEST, MODEL 9147T AWT
PHAMATECH                         510(k) NO: K010836(SPECIAL)
ATTN: CARL A MONGIOVI             PHONE NO : 858-635-5840
9530 PADGETT STREET #101          SE DECISION MADE: 11-APR-01
SAN DIEGO, CA 92126               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PHILIPS BV LIBRA
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K010762(TRADITIONAL)
ATTN: PETER  ALTMAN               PHONE NO : 203-926-7031
710 BRIDGEPORT AVE.               SE DECISION MADE: 02-APR-01
SHELTON, CT 06484                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LPC-PLUS ACETABULAR CUP
PLUS ORTHOPEDICS                  510(k) NO: K003274(TRADITIONAL)
ATTN: HARTMUT  LOCH               PHONE NO : 858-455-2400
3550 GENERAL ATOMICS CT.          SE DECISION MADE: 06-APR-01
BLDG. 15-100                      510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92121-1194

DEVICE: PREMIER ULTRASONIC SCALER AND INSERTS
PREMIER DENTAL PRODUCTS CO.       510(k) NO: K010195(TRADITIONAL)
ATTN: WILLIAN  FREZEL             PHONE NO : 215-676-9090
3600 HORIZON DR.                  SE DECISION MADE: 17-APR-01
P.O. BOX 61574                    510(k) STATEMENT
KING OF PRUSSIA, PA 19406

DEVICE: PRESCOTT'S SURGICAL SPEAR
PRESCOTT'S, INC.                  510(k) NO: K003842(TRADITIONAL)
ATTN: PAUL  REDNER                PHONE NO : 719-481-3353
P.O. BOX 609                      SE DECISION MADE: 13-APR-01
MONUMENT, CO 80132-0609           510(k) STATEMENT

DEVICE: Y-TZP POWDER AND PROCERA ALLZIRKON
PROCERA SANDVIK, INC.             510(k) NO: K010630(TRADITIONAL)
ATTN: MARTIN  STERNER             PHONE NO : 201-398-7412
1872 MCBRIDE AVE.                 SE DECISION MADE: 17-APR-01
FAIR LAWN, NJ 07410-2812          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,81
PROXIMA THERAPEUTICS, INC.        510(k) NO: K003206(TRADITIONAL)
ATTN: DEBORAH J MOORE             PHONE NO : 770-753-4848
2555 MARCONI DRIVE, SUITE 220     SE DECISION MADE: 25-APR-01
ALPHARETTA, GA 30005-2066         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DORNIR LC-1 CPAP SYSTEM
PRYM MEDICAL LTD.                 510(k) NO: K010704(SPECIAL)
ATTN: SHOSHANA  FRIEDMAN          PHONE NO : 972 9 7718130
117 AHUZAH ST.                    SE DECISION MADE: 18-APR-01
RA'ANANNA, ISRAEL 43373           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POLYMER COATED POWDER-FREE GREY COLOR POLYCHLOROPRENE PATIENT EX
PT. MEDISAFE TECHNOLOGIES         510(k) NO: K010486(TRADITIONAL)
ATTN: ANIL  TANEJA                PHONE NO : 62 061 4515834
JL. LET-JEN. S. PARMAN            SE DECISION MADE: 10-APR-01
NO. 23/235                        510(k) STATEMENT
MEDAN, INDONESIA 20153
 
DEVICE: ADVIA RETIC PLUS
R & D SYSTEMS, INC.               510(k) NO: K010461(TRADITIONAL)
ATTN: KENNETH T EDDS              PHONE NO : 612-379-2956
614 MCKINLEY PL., N.E.            SE DECISION MADE: 03-APR-01
MINNEAPOLIS, MN 55413             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: R-SI-LINE METAL-BITE
R-DENTAL DENTALERZEUGNISSE GMBH   510(k) NO: K010926(TRADITIONAL)
ATTN: ANDREAS  SPRAFKE            PHONE NO : 004 940 22757617
WINTERHUDER WEG 88                SE DECISION MADE: 12-APR-01
HAMBURG, GERMANY D-22085          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS
RAPID DIAGNOSTICS INC.            510(k) NO: K003809(TRADITIONAL)
ATTN: CHARLES C.F.  YU            PHONE NO : 650-558-0395
1429 ROLLINS RD.                  SE DECISION MADE: 20-APR-01
BURLINGAME, CA 94010              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTIFUCTION SUCTION IRRIGATION SYSTEM, EXISTING OF SUCTION IRRI
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K002000(TRADITIONAL)
ATTN: ROBERT L CASARSA            PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY.         SE DECISION MADE: 10-APR-01
VERNON HILLS, IL 60061            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MINI FIBER ENDOSCOPES; OUTER SHEATHS; VERESS CANNULAS; VERESS CA
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K003417(SPECIAL)
ATTN: ROBERT L CASARSA            PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY.         SE DECISION MADE: 04-APR-01
VERNON HILLS, IL 60061            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RITA MODEL 2500 ELECTROSURGICAL RF GENERATOR
RITA MEDICAL SYSTEMS              510(k) NO: K003676(SPECIAL)
ATTN: ERIN  MAZZONE               PHONE NO : 650-314-3439
967 NORTH SHORELINE BLVD.         SE DECISION MADE: 09-APR-01
MOUNTAIN VIEW, CA 94043           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAVITY VARNISH
RITE-DENT MANUFACTURING CORPORATIO510(k) NO: K010255(TRADITIONAL)
ATTN: CESAR E VELIZ               PHONE NO : 305-693-8626
1056 EAST 33RD ST.                SE DECISION MADE: 20-APR-01
HIALEAH, FL 33013-3526            510(k) STATEMENT

DEVICE: ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CH
ROCHE DIAGNOSTICS CORP.           510(k) NO: K004010(TRADITIONAL)
ATTN: LUANN  OCHS                 PHONE NO : 317-845-2000
9115 HAGUE RD.                    SE DECISION MADE: 26-APR-01
P.O. BOX 50457                    510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46250-0457

DEVICE: SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT
SA SCIENTIFIC, INC.               510(k) NO: K010593(TRADITIONAL)
ATTN: ARBI A SHADFAN              PHONE NO : 210-699-8800
4919 GOLDEN QUAIL                 SE DECISION MADE: 05-APR-01
SAN ANTONIO, TX 78240             510(k) STATEMENT
 
DEVICE: TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3K
SCANTIBODIES LABORATORY, INC.     510(k) NO: K004038(TRADITIONAL)
ATTN: RICHARD  LENART             PHONE NO : 619-258-9300
9336 ABRAHAM WAY                  SE DECISION MADE: 30-APR-01
SANTEE, CA 92071                  510(k) STATEMENT

DEVICE: EUROSPITAL EU-TTG IGA UMANA
SCIMEDX CORPORATION               510(k) NO: K010625(TRADITIONAL)
ATTN: GARY  LEHNUS                PHONE NO : 973-625-8822
400 FORD ROAD                     SE DECISION MADE: 24-APR-01
BLDG. 100                         510(k) STATEMENT
DENVILLE, NJ 07834

DEVICE: MODIFICATION TO MIRAGE
SEGAMI CORP., INC.                510(k) NO: K010726(TRADITIONAL)
ATTN: PHILIPPE A BRIANDET         PHONE NO : 410-381-2311
8335 GUILFORD ROAD                SE DECISION MADE: 26-APR-01
SUITE I                           510(k) STATEMENT
COLUMBIA, MD 21046

DEVICE: SENOJ IMPLANT SYSTEM
SENOJ BIOCARE, INC.               510(k) NO: K000889(TRADITIONAL)
ATTN: PENNY  WOLLUM               PHONE NO : 858-558-9690
8910 UNIVERSITY CENTER LANE       SE DECISION MADE: 27-APR-01
SUITE 265                         510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92122-1085

DEVICE: SENTECH MEDICAL EXPRESS COMPRESSION SYSTEM (P/N SM800)
SENTECH MEDICAL SYSTEMS, INC.     510(k) NO: K003701(TRADITIONAL)
ATTN: LYDIA  BIGGIE               PHONE NO : 954-739-4972
5353 N.W. 35TH AVE.               SE DECISION MADE: 05-APR-01
FT. LAUDERDALE, FL 33309          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER-FREE NITRILE EXAMINATION GLOVES, WHITE
SHEN WEI (USA), INC.              510(k) NO: K010110(TRADITIONAL)
ATTN: BELLE L CHOU                PHONE NO : 510-429-8692
2845 WHIPPLE RD.                  SE DECISION MADE: 03-APR-01
UNION CITY, CA 94587              510(k) STATEMENT

DEVICE: POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG JUNFEI PLASTIC PRODUC510(k) NO: K010626(TRADITIONAL)
ATTN: JAMES  CHU                  PHONE NO : 909-548-4828
12390 EAST END AVENUE             SE DECISION MADE: 23-APR-01
CHINO, CA 91710                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG JUNFEI PLASTIC PRODUC510(k) NO: K010627(TRADITIONAL)
ATTN: JAMES  CHU                  PHONE NO : 909-548-4828
12390 EAST END AVENUE             SE DECISION MADE: 24-APR-01
CHINO, CA 91710                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG JUNFEI PLASTIC PRODUC510(k) NO: K010628(TRADITIONAL)
ATTN: JAMES  CHU                  PHONE NO : 909-548-4828
12390 EAST END AVENUE             SE DECISION MADE: 23-APR-01
CHINO, CA 91710                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BEAUTIFIL
SHOFU DENTAL CORP.                510(k) NO: K010914(TRADITIONAL)
ATTN: CINDKY  RHOADES             PHONE NO : 650-324-0085
4025 BOHANNON DR                  SE DECISION MADE: 20-APR-01
MENLO PARK, CA 94025              510(k) STATEMENT

DEVICE: TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
SIEMENS HEARING INSTRUMENTS, INC. 510(k) NO: K003558(TRADITIONAL)
ATTN: DAVID S SLAVIN              PHONE NO : 732-562-6600
10 CONSTITUTION AVE.              SE DECISION MADE: 24-APR-01
P.O. BOX 1397                     510(k) SUMMARY AVAILABLE FROM FDA
PISCATAWAY, NJ 08855

DEVICE: TCI (TINNITUS CONTROL INSTRUMENT)
SIEMENS HEARING INSTRUMENTS, INC. 510(k) NO: K003559(TRADITIONAL)
ATTN: DAVID S SLAVIN              PHONE NO : 732-562-6600
10 CONSTITUTION AVE.              SE DECISION MADE: 26-APR-01
P.O.BOX 1397                      510(k) SUMMARY AVAILABLE FROM FDA
PISCATAWAY, NJ 08855

DEVICE: U04
SIEMENS MEDICAL SYSTEMS, INC.     510(k) NO: K010942(TRADITIONAL)
ATTN: AMY SHAW  HOSLER            PHONE NO : 732-321-4830
186 WOOD AVENUE SOUTH             SE DECISION MADE: 12-APR-01
ISELIN, NJ 08830                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: DYONICS VISION 111 MOBILE VIDEO UNIT
SMITH & NEPHEW, INC.              510(k) NO: K010489(TRADITIONAL)
ATTN: STEVEN  JACKSON             PHONE NO : 405-936-3085
3600 NW 138TH STREET              SE DECISION MADE: 10-APR-01
OKLAHOMA CITY, OK 73134           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CEDARS-SINAI BPGS AND MOCO
SMV AMERICA                       510(k) NO: K010509(TRADITIONAL)
ATTN: PAULA  MCLEAN               PHONE NO : 800-664-0844
8380 DARROW RD.                   SE DECISION MADE: 27-APR-01
TWINSBURG, OH 44087               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AT3C70 TRANSDUCER
SONORA MEDICAL SYSTEMS            510(k) NO: K002856(ABBREVIATED)
ATTN: COLLEEN  HITTLE             PHONE NO : 317-849-1916
7992 CASTLEWAY DRIVE              SE DECISION MADE: 02-APR-01
INDIANAPOLIS, IN 46250            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STANNAH POWER CHAIR, MODEL 201
STANNAH POWER CHAIRS LTD.         510(k) NO: K994083(TRADITIONAL)
ATTN: CHARLES  EDGELL             PHONE NO : 126 436 4311
WATT CLOSE                        SE DECISION MADE: 04-APR-01
EAST PORTWAY IND. ESTATE          510(k) SUMMARY AVAILABLE FROM FDA
ANDOVER, HAMPSHIRE, UNITED KINGDOM SP10 3SD
 
DEVICE: SIMPLICITY INFUSER INFUSION SET
STERLING MEDIVATIONS, INC.        510(k) NO: K010647(ABBREVIATED)
ATTN: JOEL  DOUGLAS               PHONE NO : 650-949-0470
180 FERNDALE ROAD SOUTH           SE DECISION MADE: 13-APR-01
WAYZATA, MN 55391                 510(k) STATEMENT

DEVICE: SIMPLICITY WINGED QD INFUSION SET
STERLING MEDIVATIONS, INC.        510(k) NO: K010676(ABBREVIATED)
ATTN: JOEL  DOUGLAS               PHONE NO : 650-949-0470
180 FERNDALE ROAD SOUTH           SE DECISION MADE: 18-APR-01
WAYZATA, MN 55391                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIMPLICITY SOFT QD EASY INFUSION SET
STERLING MEDIVATIONS, INC.        510(k) NO: K010788(ABBREVIATED)
ATTN: JOEL S DOUGLAS              PHONE NO : 952-473-7971
180 FERNDALE ROAD SOUTH           SE DECISION MADE: 20-APR-01
WAYZATA, MN 55391                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIMPLICITY SILVER SET SOFT INFUSION
STERLING MEDIVATIONS, INC.        510(k) NO: K010846(ABBREVIATED)
ATTN: JOEL  DOUGLAS               PHONE NO : 952-473-7971
180 FERNDALE ROAD SOUTH           SE DECISION MADE: 12-APR-01
WAYZATA, MN 55391                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIMPLICITY WING INFUSION SET
STERLING MEDIVATIONS, INC.        510(k) NO: K010886(ABBREVIATED)
ATTN: JOEL S DOUGLASS             PHONE NO : 952-473-7971
180 FERNDALE ROAD SOUTH           SE DECISION MADE: 30-APR-01
WAYZATA, MN 55391                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES
STRYKER INSTRUMENTS               510(k) NO: K010969(SPECIAL)
ATTN: ROBIN L ROWE                PHONE NO : 616-324-5346
4100 EAST MILHAM AVE.             SE DECISION MADE: 20-APR-01
KALAMAZOO, MI 49001               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLS VARUS STEM/CLS 135 STEM
SULZER ORTHOPEDICS, INC.          510(k) NO: K010839(SPECIAL)
ATTN: BRUCE  WALDON               PHONE NO : 512-432-9900
9900 SPECTRUM DR.                 SE DECISION MADE: 18-APR-01
AUSTIN, TX 78717                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GL
SURETEX, LTD.                     510(k) NO: K010371(ABBREVIATED)
ATTN: LON D MCILVAIN              PHONE NO : 334-794-4231
1500 INDUSTRIAL ROAD              SE DECISION MADE: 27-APR-01
P.O. BOX 1252                     510(k) SUMMARY AVAILABLE FROM FDA
DOTHAN, AL 36302

DEVICE: SONOTOME ULTRASONIC ASPIRATOR TIPS
SYNERGETICS, INC.                 510(k) NO: K010637(TRADITIONAL)
ATTN: ALAN T BECKMAN              PHONE NO : 636-939-5100
88 HUBBLE DR.                     SE DECISION MADE: 20-APR-01
ST. CHARLES, MO 63304-8694        510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SYNTHES SYNMESH SPACER SYSTEM
SYNTHES (USA)                     510(k) NO: K003275(TRADITIONAL)
ATTN: JONATHAN  GILBERT           PHONE NO : 610-647-9700
1690 RUSSELL RD.                  SE DECISION MADE: 23-APR-01
PAOLI, PA 19301                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO SYNTHES (USA) POLYPIN
SYNTHES (USA)                     510(k) NO: K003527(TRADITIONAL)
ATTN: THOMAS M MAGUIRE            PHONE NO : 610-647-9700
P.O. BOX 1766                     SE DECISION MADE: 09-APR-01
1690 RUSSELL ROAD                 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301-1222

DEVICE: SYNTHES (USA) IMF SCREWS
SYNTHES (USA)                     510(k) NO: K010527(TRADITIONAL)
ATTN: THOMAS M MAGUIRE            PHONE NO : 610-647-9700
P.O. BOX 1766                     SE DECISION MADE: 25-APR-01
1690 RUSSELL ROAD                 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301-1222

DEVICE: EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229
SYVA CO., DADE BEHRING INC.       510(k) NO: K010812(SPECIAL)
ATTN: VIRGINIA  SINGER            PHONE NO : 408-239-2175
P.O. BOX 49013                    SE DECISION MADE: 13-APR-01
3403 YERBA BUENA ROAD             510(k) SUMMARY AVAILABLE FROM FDA
SAN JOSE, CA 95135

DEVICE: EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229
SYVA CO., DADE BEHRING INC.       510(k) NO: K010814(SPECIAL)
ATTN: VIRGINIA  SINGER            PHONE NO : 408-239-2175
P.O. BOX 49013                    SE DECISION MADE: 13-APR-01
3403 YERBA BUENA ROAD             510(k) SUMMARY AVAILABLE FROM FDA
SAN JOSE, CA 95135

DEVICE: EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229
SYVA CO., DADE BEHRING INC.       510(k) NO: K010934(SPECIAL)
ATTN: VIRGINIA  SINGER            PHONE NO : 408-239-2175
P.O. BOX 49013                    SE DECISION MADE: 20-APR-01
3403 YERBA BUENA ROAD             510(k) SUMMARY AVAILABLE FROM FDA
SAN JOSE, CA 95135

DEVICE: EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229
SYVA CO., DADE BEHRING INC.       510(k) NO: K010960(SPECIAL)
ATTN: SUSAN  COLLINS              PHONE NO : 408-239-4412
P.O. BOX 49013                    SE DECISION MADE: 26-APR-01
3403 YERBA BUENA ROAD             510(k) SUMMARY AVAILABLE FROM FDA
SAN JOSE, CA 95135

DEVICE: EMIT II PLUS METHADONE ASSAY, MODEL OSRE229
SYVA CO., DADE BEHRING INC.       510(k) NO: K010962(SPECIAL)
ATTN: VIRGINIA  SINGER            PHONE NO : 408-239-2175
P.O. BOX 49013                    SE DECISION MADE: 26-APR-01
3403 YERBA BUENA ROAD             510(k) SUMMARY AVAILABLE FROM FDA
SAN JOSE, CA 95135
 
DEVICE: EMIT 2000 GENTAMICIN PLUS ASSAY
SYVA CO., DADE BEHRING INC.       510(k) NO: K010984(SPECIAL)
ATTN: VIRGINIA  SINGER            PHONE NO : 408-239-2175
3403 YERBA BUENA ROAD             SE DECISION MADE: 20-APR-01
SAN JOSE, CA 95135                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GRAFT MARKER RING
T. KOROS SURGICAL INSTRUMENTS CORP510(k) NO: K001915(TRADITIONAL)
ATTN: TIBOR  KOROS                PHONE NO : 805-529-0825
610 FLINN AVE.                    SE DECISION MADE: 27-APR-01
MOORPARK, CA 93021                510(k) STATEMENT

DEVICE: TAGA VELOCITY PASSOVER HUMIDIFIER UNIT, MODEL MP1017
TAGA MEDICAL TECHNOLOGIES, INC.   510(k) NO: K010578(TRADITIONAL)
ATTN: GARY  AUSTIN                PHONE NO : 440-963-9605
7561 TYLER BLVD                   SE DECISION MADE: 25-APR-01
UNIT 8                            510(k) SUMMARY AVAILABLE FROM FDA
MENTOR, OH 44060

DEVICE: URS-1K (KETONE TESST)
TECO DIAGNOSTICS                  510(k) NO: K003987(TRADITIONAL)
ATTN: DINDO  CARRILLO             PHONE NO : 714-693-7788
4925 EAST HUNTER AVE.             SE DECISION MADE: 26-APR-01
ANAHEIM, CA 92807                 510(k) STATEMENT

DEVICE: FLEXIBLE ENDOSCOPIC SCISSORS
TELEMED SYSTEMS, INC.             510(k) NO: K010412(TRADITIONAL)
ATTN: MICHAEL  CARROLL            PHONE NO : 978-567-9033
8 KANE INDUSTRIAL DRIVE           SE DECISION MADE: 02-APR-01
HUDSON, MA 01749                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TEMP SCAN
TENGHI CO. LTD                    510(k) NO: K010383(TRADITIONAL)
ATTN: TONY C S. CHANG             PHONE NO : 886 422 972776
# 5, ALLEY 5, LANE CHENG HSING    SE DECISION MADE: 18-APR-01
CHUNG CHING RD. PEI TUN DIST.     510(k) SUMMARY AVAILABLE FROM FDA
TAICHUNG, CHINA (TAIWAN)

DEVICE: TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE
TERATECH CORPORATION              510(k) NO: K010883(TRADITIONAL)
ATTN: CHARLES F HOTTINGER         PHONE NO : 408-741-1006
19030 PORTOS DRIVE                SE DECISION MADE: 06-APR-01
SARATOGA, CA 95070                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: FREELITE LAMBDA FREE KIT
THE BINDING SITE, LTD.            510(k) NO: K010440(TRADITIONAL)
ATTN: JAY H GELLER                PHONE NO : 310-449-1399
WEST TOWER, SUITE 4000            SE DECISION MADE: 26-APR-01
2425 WEST OLYMPIC BOULEVARD       510(k) STATEMENT
SANTA MONICA, CA 90404
 
DEVICE: FREELITE KAPPA FREE KIT
THE BINDING SITE, LTD.            510(k) NO: K010441(TRADITIONAL)
ATTN: JAY H GELLER                PHONE NO : 310-449-1399
WEST TOWER, SUITE 4000            SE DECISION MADE: 26-APR-01
2425 WEST OLYMPIC BOULEVARD       510(k) STATEMENT
SANTA MONICA, CA 90404

DEVICE: TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS
THE KENDALL COMPANY               510(k) NO: K002902(TRADITIONAL)
ATTN: FRANK J FUCILE              PHONE NO : 508-261-8532
15 HAMPSHIRE STREET               SE DECISION MADE: 09-APR-01
MANSFIELD, MA 02048               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200
THERAGENICS CORP.                 510(k) NO: K010283(TRADITIONAL)
ATTN: JANET E ZEMAN               PHONE NO : 770-271-0233
5203 BRISTOL INDUSTRIAL WAY       SE DECISION MADE: 26-APR-01
BUFORD, GA 30518                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THINKINGNET
THINKING SYSTEMS CORPORATION      510(k) NO: K010271(TRADITIONAL)
ATTN: J B WANG                    PHONE NO : 408-865-0355
6119 PRINCE DRIVE                 SE DECISION MADE: 03-APR-01
SAN JOSE, CA 95129                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VA
THOMAS MEDICAL PRODUCTS INC.      510(k) NO: K003731(TRADITIONAL)
ATTN: PETER J RAPP                PHONE NO : 610-296-3000
65 GREAT VALLEY PKWY.             SE DECISION MADE: 10-APR-01
MALVERN, PA 19355                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO TISSUELINK MONOPOLAR FLOATING BALL
TISSUELINK MEDICAL INC.           510(k) NO: K010662(TRADITIONAL)
ATTN: ROBERTA  THOMPSON           PHONE NO : 603-742-1515
ONE WASHINGTON CENTER             SE DECISION MADE: 27-APR-01
SUITE 400                         510(k) SUMMARY AVAILABLE FROM FDA
DOVER, NH

DEVICE: POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE
TONG RUHN MEDICAL PRODUCTS CO., IN510(k) NO: K010671(TRADITIONAL)
ATTN: ANTONIO L GIACCIO           PHONE NO : 815-385-0100
1202 S. RTE 31                    SE DECISION MADE: 09-APR-01
MCHENRY, IL 60050                 510(k) STATEMENT

DEVICE: EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K010129(TRADITIONAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714-730-5000
2441 MICHELLE DR.                 SE DECISION MADE: 05-APR-01
P.O. BOX 2068                     510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068

DEVICE: TRANSAMERICA DIGITAL EMS
TRANSAMERICA MEDICAL SYSTEMS      510(k) NO: K010665(SPECIAL)
ATTN: JOHN F DUNN                 PHONE NO : 413-535-1115
350 RACE STREET                   SE DECISION MADE: 27-APR-01
HOLYOKE, MA 01040                 510(k) STATEMENT
 
DEVICE: TRANSAMERICAN TENS
TRANSAMERICA MEDICAL SYSTEMS      510(k) NO: K010782(SPECIAL)
ATTN: JOHN F DUNN                 PHONE NO : 413-535-1115
350 RACE STREET                   SE DECISION MADE: 27-APR-01
HOLYOKE, MA 01040                 510(k) STATEMENT

DEVICE: NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE
TYCO HEALTHCARE GROUP LP          510(k) NO: K010909(SPECIAL)
ATTN: ROBERT  ZOTT                PHONE NO : 203-845-4515
150 GLOVER AVENUE                 SE DECISION MADE: 09-APR-01
NORWALK, CT 06856                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHIELDING NEEDLE HOLDER
U.S. SAFETY SYRINGES CO., INC.    510(k) NO: K003381(TRADITIONAL)
ATTN: DAVID A HOINES              PHONE NO : 954-561-9500
1290 EAST OAKLAND PARK BLVD.      SE DECISION MADE: 23-APR-01
SUITE 200                         510(k) STATEMENT
FORT LAUDERDALE, FL 33334-4447

DEVICE: IVS TUNNELLER
UNITED STATES SURGICAL, A DIVISION510(k) NO: K010035(TRADITIONAL)
ATTN: CHESTER  MCCOY              PHONE NO : 203-845-1390
150 GLOVER AVE                    SE DECISION MADE: 04-APR-01
NORWALK, CT 06850                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO CAVERMAP SURGICAL AID
UROMED CORP.                      510(k) NO: K010213(TRADITIONAL)
ATTN: FREDERICK  TOBIA            PHONE NO : 781-762-2080
1400 PROVIDENCE HWY.              SE DECISION MADE: 20-APR-01
NORWOOD, MA 02062                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODE
VALLEYLAB, INC.                   510(k) NO: K010010(TRADITIONAL)
ATTN: JULIE  ROSS                 PHONE NO : 303-581-6773
5920 LONGBOW DRIVE                SE DECISION MADE: 02-APR-01
BOULDER, CO 80301-3299            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VISTAKON (METHAFILCON A) CONTACT LENSES
VISTAKON                          510(k) NO: K010507(TRADITIONAL)
ATTN: MICHAEL J TERSAK            PHONE NO : 904-443-1402
7500 CENTURION PARKWAY            SE DECISION MADE: 12-APR-01
SUITE 100                         510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32256

DEVICE: ANEUVYSION MULITICOLOR DNA PROBE KIT
VYSIS                             510(k) NO: K010288(TRADITIONAL)
ATTN: RUSSEL K ENNS               PHONE NO : 630-271-7040
3100 WOODCREEK DRIVE              SE DECISION MADE: 13-APR-01
DOWNERS GROVE, IL 60515           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LACTOSORB ETHMOID STENT
WALTER LORENZ SURGICAL, INC.      510(k) NO: K002131(TRADITIONAL)
ATTN: TREVOR  BYRD                PHONE NO : 800-874-7711
1520 TRADEPORT DR.                SE DECISION MADE: 13-APR-01
JACKSONVILLE, FL 32218            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHOUT F
WHITE KNIGHT HEALTHCARE, INC.     510(k) NO: K001892(TRADITIONAL)
ATTN: ART  WARD                   PHONE NO : 813-645-2855
3234 ELLA LANE                    SE DECISION MADE: 03-APR-01
NEW PORT RICHEY, FL 34655         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS)
WHITE KNIGHT HEALTHCARE, INC.     510(k) NO: K001893(TRADITIONAL)
ATTN: ART  WARD                   PHONE NO : 813-645-2855
3234 ELLA LANE                    SE DECISION MADE: 02-APR-01
NEW PORT RICHEY, FL 34655         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS)
WHITE KNIGHT HEALTHCARE, INC.     510(k) NO: K001997(TRADITIONAL)
ATTN: ART  WARD                   PHONE NO : 813-645-2855
3234 ELLA LANE                    SE DECISION MADE: 02-APR-01
NEW PORT RICHEY, FL 34655         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO
WIENER LABORATORIES S.A.I.C.      510(k) NO: K010421(TRADITIONAL)
ATTN: VIVIANA  CETOLA             PHONE NO : 54 341 4329191
2944 RIOBAMBA                     SE DECISION MADE: 13-APR-01
ROSARIO, ARGENTINA 2000           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOFTLASE - SURGICAL DIODE LASER SYSTEM
ZAP LASERS, INC.                  510(k) NO: K003440(TRADITIONAL)
ATTN: DAVID W SCHLERF             PHONE NO : 925-356-2640
200 GREGORY LANE                  SE DECISION MADE: 20-APR-01
SUITE C-100                       510(k) SUMMARY AVAILABLE FROM FDA
PLEASANT HILL, CA 94523-3389

DEVICE: MODIFICATION TO MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYS
ZIMMER, INC.                      510(k) NO: K010685(SPECIAL)
ATTN: STEPHEN H MCKELVEY          PHONE NO : 219-372-4944
P.O. BOX 708                      SE DECISION MADE: 02-APR-01
WARSAW, IN 46581-0708             510(k) SUMMARY AVAILABLE FROM FDA

 
                                                TOTAL 510(k)s THIS PERIOD   254
                                                TOTAL WITH SUMMARIES        199
                                                TOTAL WITH STATEMENTS        55

Updated 7/30/2001

horizonal rule

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