FDA 510(k) Decisions During October, 2001  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K000741 10/24/2001 EMS JUMPER II DUAL CHANNEL NEUROMUSCULAR STIMULATOR SYSTEM, MODEL E-188 138 MEDICAL SUPPLIES, INC. SUSAN D GOLDSTEIN-FALK
K010127 10/05/2001 W & H ASSISTINA A-DEC, INC. LOVENA STANDRIDGE
K011337 10/16/2001 ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA) ACCUMETRICS, INC. RHONDA MOE
K012595 10/15/2001 ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K011248 10/29/2001 CW DISPOSABLE ACUPUNCTURE NEEDLE ACUSUPPLY, INC. FERES DAGER
K011247 10/17/2001 HOLY DRAGON STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE ACUSUPPLY, INC. FERES DAGER
K002632 10/25/2001 OXYGENATOR ADJUNCTIVE THERAPEUTICS, INC. MYRON Z BERNSTEIN
K011265 10/30/2001 ULTRASOUND TRANSDUCER COVER ADVANCE MEDICAL DESIGNS, INC. BILL GILL
K012928 10/09/2001 ABI VEST AIRWAY CLEARANCE SYSTEM ADVANCED RESPIRATORY ERIC J LARSON
K012986 10/03/2001 BIPOLAR IRRIGATION FORCEPS AESCULAP, INC. LISA M MILLINGTON
K013176 10/16/2001 MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE AFP IMAGING CORP. MARY MCNAMARA-CULLINANE
K012383 10/02/2001 GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C ALARIS MEDICAL SYSTEMS, INC. RENEE L FLUET
K012335 10/01/2001 BROWNE METREX 1.8% GLUTARALDEHYDE INDICATOR FOR METRICIDE 28 AND METRICIDE PLUS 30 SOLUTIONS ALBERT BROWNE LTD. CYNTHIA J.M. NOLTE
K012625 10/22/2001 REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS ALLIANCE MEDICAL CORP. DON SELVEY
K011814 10/22/2001 AMEDITECH IMMUTEST DRUG SCREEN COC AMEDITECH, INC. JOHN WU
K011813 10/22/2001 AMEDITECH IMMUTEST DRUG SCREEN THC AMEDITECH, INC. JOHN WU
K012127 10/04/2001 PULSEMASTER ERBIUM DENTAL LASER SYSTEM AMERICAN DENTAL TECHNOLOGIES, INC. SHEILA HEMEON-HEYER
K013355 10/26/2001 SPARC SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC. GINGER S GLASER
K012464 10/10/2001 HELIX HYDRO-JET ANDREAS PEIN MEDIZINTECHNIK GMBH ROBERT N CLARK
K010729 10/26/2001 AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A ANDROMED, INC. JULIA LALE AKTIK
K012643 10/29/2001 APEX MEDICAL LCD TENS-VII APEX MEDICAL CORP. ALAN CHANG
K012140 10/05/2001 COM-PATCH APEX MEDICAL CORP. ALAN CHANG
K010869 10/11/2001 EPOCA CUSTOM OFFSET SHOULDER SYSTEM ARGOMEDICAL AG DONALD A STEVENS
K011056 10/24/2001 ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR "PTD" ARROW INTL., INC. THOMAS D NICKEL
K011761 10/31/2001 MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT ARROW INTL., INC. THOMAS D NICKEL
K012923 10/04/2001 ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201 ARTHREX, INC. ANN WATERHOUSE
K012519 10/25/2001 ARTHROCARE ELECTROSURGERY WANDS ARTHROCARE CORP. BRUCE PROTHRO
K010477 10/09/2001 AUTO-LOCK AUTO-LOCK DIETRICH W GRABIS
K012435 10/02/2001 ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626 BAUSCH & LOMB, INC. VANADA JOHNSON
K012777 10/22/2001 ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS BAYER CORP. KENNETH T EDDS
K013272 10/25/2001 ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY BAYER CORP. KENNETH T EDDS
K012340 10/01/2001 BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) BAYER CORP. KENNETH T EDDS
K012900 10/16/2001 ACCESS UNCONJUGATED ESTRIOL CALIBRATORS BECKMAN COULTER, INC. MARA CALER
K013235 10/16/2001 MODIFICATION TO SYNCHRON CONTROL BECKMAN COULTER, INC. MARY BETH TANG
K012384 10/15/2001 EAR MUFFINS BIO-LOGIC SYSTEMS CORP. NORMAN E BRUNNER
K012997 10/25/2001 COLLATEK FOAM BIOCORE MEDICAL TECHNOLOGIES, INC. AJAY KUMAR
K012990 10/24/2001 COLLATEK POWDER BIOCORE MEDICAL TECHNOLOGIES, INC. AJAY KUMAR
K012995 10/25/2001 COLLATEK SHEET BIOCORE MEDICAL TECHNOLOGIES, INC. AJAY KUMAR
K012955 10/22/2001 COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER BIOFORM, INC. VICTOR M BOWERS
K010804 10/04/2001 MEGABEAM/CERALAS REUSEABLE HANDPIECE AND DISPOSABLE TIPS BIOLITEC, INC. CAROL J MORELLO
K012503 10/22/2001 METAL SCREW ANCHOR BIOMET MANUFACTURING, INC. SARA B SHULTZ
K013042 10/10/2001 DISCOVERY ELBOW BIOMET ORTHOPEDICS, INC. SARA B SHULTZ
K012559 10/16/2001 POLY STAT HCG TEST BION DIAGNOSTIC SCIENCES HELEN LANDICHO
K013147 10/24/2001 GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE BIONOSTICS, INC. KATHY STORRO
K013057 10/12/2001 BIOCUFF,C, MODELS 236018, 236028, 236036 BIONX IMPLANTS, INC. TUIJA ANNALA
K013002 10/03/2001 TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002 BIOSITE INCORPORATED JEFFREY R DAHLEN
K012999 10/03/2001 TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001 BIOSITE INCORPORATED JEFFREY R DAHLEN
K013194 10/10/2001 UNIMARK HCG COMBO PREGNANCY TEST BIOTECH ATLANTIC, INC. FRANCIS LEE
K012465 10/29/2001 MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR BONUTTI RESEARCH, INC. PATRICK BALSMANN
K013153 10/19/2001 AUTOTOME RX MODEL # 4515, 4516 BOSTON SCIENTIFIC CORP. LISA M QUAGLIA
K012864 10/24/2001 INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836 BOSTON SCIENTIFIC CORP. JAMES D MCMAHON
K012883 10/12/2001 ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM BOSTON SCIENTIFIC CORP. KATHLEEN MORAHAN
K012822 10/24/2001 MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX BOSTON SCIENTIFIC SCIMED, INC. TODD KORNMANN
K012952 10/02/2001 HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT BOSTON SCIENTIFIC/MEDI-TECH JENNIFER BOLTON
K012948 10/03/2001 MODIFICATION TO VAXCEL DIALYSIS CATHETER BOSTON SCIENTIFIC/MEDI-TECH NICHOLAS CONDAKES
K012345 10/03/2001 NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR BROMAC ASSISTIVE TECHNOLOGY DAVID K BROWN
K013111 10/01/2001 EXHALE PROBE BRONCUS TECHNOLOGIES, INC. TIMOTHY R WILLIAMS
K013144 10/19/2001 DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE; DUAL PORT WIZARD FEEDING/DECOMPRESSION TUBE, MODEL 00220W C.R. BARD, INC. MARION GORDON
K012206 10/12/2001 ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM CAMBRIDGE HEART, INC. JOHN GREENBAUM
K013043 10/11/2001 CANDELA CLEARBEAM PULSED DYE LASER CANDELA CORP. JOAN CLIFFORD
K013175 10/30/2001 TM2000 EASYTRACE PLUS RECEIVING CENTER CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K010396 10/04/2001 C. NET 2100 CARDIONETICS, LTD. BARRY SALL
K003238 10/01/2001 SOLID STATE X-RAY IMAGING DEVICES CARES BUILT, INC. TIMOTHY D TELYMONDE
K012126 10/03/2001 THE SALICEPT ORAL PATCH CARRINGTON LABORATORIES, INC. KENNETH M YATES
K013336 10/29/2001 XANTALGIN CRONO CAVEX HOLLAND B.V. RICHARD WOORTMAN
K012886 10/09/2001 CBYON SYSTEM WITH IMAGE ENHANCED FLUOROSCOPY MODULE CBYON, INC. KRISHNA SUDHAKARAN
K012446 10/03/2001 OFFICE BASED ANESTHESIA MACHINE MRI, MODEL OBA-1 MRI CHARLES A. SMITH CHARLES A SMITH
K013458 10/29/2001 CRANIAL HELMET CHILDREN'S HOSPITAL CONNIE FICKLIN
K012265 10/17/2001 METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088 CIRCON VIDEO WAYNE B STERNER
K001509 10/26/2001 STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE COBE CARDIOVASCULAR, INC. LYNNE LEONARD
K003322 10/01/2001 CODMAN BACTISEAL CATHETERS CODMAN & SHURTLEFF, INC. JAMES M FLAHERTY
K003661 10/05/2001 SOCRATES ROBOTIC TELEMONITORING SYSTEM COMPUTER MOTION, INC. DAVID THOMAS
K003431 10/05/2001 ZEUS ROBOTIC SURGICAL SYSTEM COMPUTER MOTION, INC. DAVID THOMAS
K010954 10/09/2001 CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90031 CONCENTRIC MEDICAL, INC. KEVIN MACDONALD
K010016 10/09/2001 MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER COOK, INC. LISA HOPKINS
K012993 10/05/2001 MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTEM CORDIS CORP. SAM MIRZA
K011502 10/22/2001 CRYSTAL AND CRYSTAL-CARE IMPLANTS SYSTEM CRYSTAL-SEAL DENTAL IMPLANTS CLINT FOLSOM
K013504 10/31/2001 MODIFICATION TO: ECAT LSO PET/CT SCANNER CTI PET SYSTEMS, INC. WILLIAM SKREMSKY
K010615 10/12/2001 CYCLOTEC AMT CTI TENS DEVICE CYCLOTEC STEPHEN A MICHELSON
K013130 10/18/2001 N LP(A) CONTROL SY DADE BEHRING, INC. REBECCA S AYASH
K012354 10/10/2001 SNOWPOST, SNOWLIGHT DANVILLE MATERIALS, INC. CRAIG R BRUNS
K013156 10/19/2001 MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM DATA CRITICAL CORP. TERESA DAVIDSON
K010715 10/04/2001 AL-40 DDC TECHNOLOGIES, INC. DMITRY DONSKOY
K013230 10/25/2001 CERCON BASE DEGUSSA - NEY DENTAL, INC. THOMAS CAMERON
K013154 10/19/2001 MARK II/MARK III MANOMETRIC PERFUSION PUMP DENTSLEEVE PTY., LTD. ROBERT N CLARK
K012235 10/04/2001 DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER DENVER BIOMEDICAL, INC. BONNIE B VIVIAN
K012971 10/05/2001 ISOLA SPINAL SYSTEMS DEPUY ACROMED LISA GILMAN
K013294 10/09/2001 MONARCH SPINAL SYSTEMS DEPUY ACROMED LISA GILMAN
K013296 10/09/2001 MOSS MIAMI SPINAL SYSTEMS DEPUY ACROMED LISA GILMAN
K013295 10/09/2001 TIMX SPINAL SYSTEMS DEPUY ACROMED LISA GILMAN
K012364 10/19/2001 AML HIP PROSTHESIS DEPUY ORTHOPAEDICS, INC. MARCIA J ARENTZ
K013134 10/15/2001 IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS) DIAGNOSTIC PRODUCTS CORP. EDWARDS M LEVINE
K013135 10/19/2001 IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS) DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K012450 10/26/2001 DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM DIAMEDIX CORP. LYNNE STIRLING
K012449 10/26/2001 DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM DIAMEDIX CORP. LYNNE STIRLING
K004001 10/04/2001 MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR DIDECO BARBARA WATSON
K012967 10/04/2001 MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING SYSTEM DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. ELAD MAGAL
K013236 10/17/2001 LUXABITE DMG USA, INC. PAMELA PAPINEAU
K013179 10/12/2001 LUXAGLAZE DMG USA, INC. PAMELA PAPINEAU
K013237 10/22/2001 STATUSBLUE DMG USA, INC. PAMELA PAPINEAU
K012821 10/22/2001 D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM DUTCH OPHTHALMIC USA, INC. MARK W FURLONG
K013142 10/05/2001 DIASUS DYNAMIC IMAGING LTD. ALLEN FINDLAY
K012474 10/03/2001 ATAC PAK CPK REAGENT KIT ELAN HOLDINGS, INC. WYNN STOCKING
K012906 10/09/2001 ANIMEC, MODELS AM-2S-4 AND AM-2S-5 ELLTEC CO., LTD. GENSHIRO OGAWA
K013191 10/24/2001 PASS SPINAL SYSTEM ENCORE ORTHOPEDICS, INC. JOANNA DROEGE
K003811 10/11/2001 CRYOCARE SURGICAL SYSTEM ENDOCARE, INC. VINCENT CUTARELLI
K012333 10/17/2001 FLEXI-SITE SP02 EAR SENSOR EPIC MEDICAL EQUIPMENT SERVICES, INC. KRISTA OAKES
K013348 10/26/2001 MODIFICATION TO: ERBE APC CONNECTOR HOSE AND PROBES, MODELS 20132-158, 20132-155, 20132-156, 20132-157, 20132-166 ERBE USA, INC. JOHN TARTAL
K012176 10/01/2001 ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105, DH145, SH105, SH145 ETHICON ENDO-SURGERY, INC. RUTH A WOOD
K011794 10/01/2001 XLTEK LED GOGGLES, MODEL LED-01 EXCEL TECH. LTD. SONJA MARKEZ
K012141 10/25/2001 AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE EXTERNAL COUNTERPULSATION LAB AHAVA STEIN
K012641 10/15/2001 FAS ENDOLUMINAL BRUSH FAS MEDICAL LTD. THOMAS KROENKE
K012230 10/09/2001 PHEM-ALERT FEMTEK,LLC. JOEL S FADEN
K011530 10/16/2001 VERTRAN STANDING WHEELCHAIR FENA DESIGN, INC. ELAINE DUNCAN
K013395 10/30/2001 LIFEJET VIDEO LINK FERRANIA S.P.A. ING. MANNELLA PAOLO
K013229 10/12/2001 LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE FERRANIA USA, INC. DOUG HALE
K013118 10/15/2001 MODIFICATION TO ALPHA DX SYSTEM FIRST MEDICAL, INC. GREG HOLLAND
K002839 10/04/2001 END EXPIRATORY FILTER, MODEL RT020 FISHER & PAYKEL HEALTHCARE, LTD. CHRIS MANDER
K012947 10/02/2001 SMARTFLOW FLORENCE MEDICAL LTD. SHOSHANA FRIEDMAN
K012497 10/30/2001 CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1 GALIL MEDICAL LTD. JONATHAN S KAHAN
K010985 10/10/2001 GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L GAMBRO RENAL PRODUCTS JEFFREY R SHIDEMAN
K011221 10/31/2001 PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET GAMBRO RENAL PRODUCTS SUZANNE DENNIS
K013198 10/29/2001 FUJI VII CAPSULE GC AMERICA, INC. TERRY L JORITZ
K012542 10/16/2001 REVOTEK LC GC AMERICA, INC. TERRY L JORITZ
K013422 10/30/2001 CARDIQ FUNCTION GE MEDICAL SYSTEMS STEVEN J KACHELMEYER
K013381 10/26/2001 ADVANCED LUNG ANALYSIS-1 GENERAL ELECTRIC CO. STEVEN J KACHELMEYER
K012466 10/01/2001 BIS/EEG MODULE GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN KAREN WEBB
K012532 10/30/2001 SEPRAGEL SINUS GENZYME CORP. NANCY A IMMEL
K013026 10/15/2001 POWDERED LATEX EXAMINATION GLOVES GREAT GLOVE (THAILAND) CO. LTD. KM LEE
K012628 10/26/2001 GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM GYNECARE CENTER GREGORY JONES
K013033 10/23/2001 MODIFICATION TO: HL168W TOUCH SCREEN HEALTH & LIFE CO., LTD. PAUL YANG
K012649 10/15/2001 RAICHEM BUN RATE REAGENT HEMAGEN DIAGNOSTICS, INC. JOSE A MONTANEZ
K012668 10/15/2001 RAICHEM GLUCOSE UV REAGENT HEMAGEN DIAGNOSTICS, INC. JOSE A MONTANEZ
K012914 10/01/2001 SONICWAVE SONIC PLAQUE REMOVER HOMEDICS, INC. DAVID VANDERLIN
K011916 10/31/2001 SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES HORIZON MEDICAL PRODUCTS, INC. PENNY M NORTHCUTT
K012726 10/18/2001 PROSAFE SAFETY SYRINGE HOU-SE MEDICAL INC JOSEPH J CHANG
K012172 10/10/2001 DURACON PS LIPPED TIBIAL INSERT HOWMEDICA OSTEONICS MARY-CATHERINE DILLON
K012719 10/22/2001 NAVIGUS II MR IMAGE-GUIDED NEUROLOGICS, INC. DAVID M LEE
K012366 10/01/2001 NAVIGUS II TRAJECTORY GUIDE IMAGE-GUIDED NEUROLOGICS, INC. DAVID M LEE
K012419 10/24/2001 CONFORM SHEETING, MODEL IGEL IMPLANTECH ASSOCIATES, INC. STEPHEN MEADE
K010997 10/15/2001 PAM-RL INDIVIDUAL MONITORING SYSTEMS, INC. DAVID T KRAUSMAN
K013039 10/05/2001 INION CPS 2.0 ORTHOGNATHIC PLATE INION LTD. HANNA MARTTILA
K003229 10/26/2001 BIOPATCH ANTIMICROBIAL DRESSING INTEGRA LIFESCIENCES CORP. WILLIAM GOELLER
K002132 10/18/2001 ASHA TREATMENT PLANNING SYSTEM, MODEL ASHA TPS INTELLIGENT INSTRUMENTS PVT. LTD. S.L. KAPOOR
K012909 10/24/2001 XTERRA GT POWER WHEELCHAIR INVACARE CORP. EDWARD A KROLL
K011365 10/26/2001 VITALSAT PULSE OXIMETER, MODEL IC32000 ISLAND CRITICAL CARE CORP. SEAN FLANIGAN
K012358 10/15/2001 CHIBA NEEDLE ISPG, INC. LORETTA F LUHMAN
K013275 10/19/2001 ASTRALIS 10, MODELS # 559588, 561859 IVOCLAR VIVADENT, INC. DONNA MARIE HARTNETT
K013277 10/22/2001 ASTRALIS 7, MODEL 557545 IVOCLAR VIVADENT, INC. DONNA MARIE HARTNETT
K012482 10/16/2001 STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION KARL STORZ ENDOSCOPY-AMERICA, INC. JENNIFER PORTUGAL
K012404 10/12/2001 K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 KATECHO, INC. WARREN R WALTERS
K013375 10/29/2001 BELLEGLASS HP OPAQUE 2 KERR DENTAL MATERIALS CENTER COLLEEN BOSWELL
K013325 10/23/2001 POINT 4 FLOWABLE 2 KERR DENTAL MATERIALS CENTER COLLEEN BOSWELL
K012946 10/02/2001 SUNLITELED MODEL #2810 KINETIC INSTRUMENTS, INC. WILLIAM J BECKER
K012485 10/09/2001 MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE KING SYSTEMS CORP. CHARLES A BURT
K012714 10/31/2001 ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR KOON SENG SDN.BHD LIM WENG HENG
K010202 10/31/2001 OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION PROBES LESLIE W. ORGAN LESLIE W ORGAN
K012320 10/19/2001 POWERPRO BATTERY SYSTEM LINVATEC CORP. LAURA D SENEFF
K013290 10/24/2001 MODIFIED 650 MAMMOGRAPHY SYSTEM LORAD, A HOLOGIC CO. ROAIDA RIZKALLAH
K012491 10/24/2001 MACHNET CAROTIDS COIL ARRAY ASSEMBLY MACHNET BV DANIEL KAMM
K012769 10/25/2001 MACROPORE ENT RECONSTRUCTION FILM MACROPORE BIOSURGERY, INC. KENNETH K KLEINHENZ
K012992 10/03/2001 MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND MASIMO SERIES OF SENSORS AND CABLES MASIMO CORP. JAMES J CRONIN
K001974 10/24/2001 EZ-ON CONDOM MAYER LABORATORIES DAVID P MAYER
K010706 10/05/2001 THINNER RESOLVE FITNESS MONITOR/BODY SCALE, HEALTH-O-METER MEASUREMENT SPECIALTIES, INC. CAROL PATTERSON
K011373 10/12/2001 INSTRUMENT DAMPING PORT MEDCANICA, INC. AL WEISENBORN
K011349 10/05/2001 INTERCOSTAL LOCKABLE-DIRECTABLE PORT MEDCANICA, INC. CHRISTIAN L MAZZOLA
K013162 10/19/2001 14F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 32CM ASH SPLIT-CATH, 14FX36CM ASH SPLIT-CATH, 14F X 40CM ASH MEDCOMP JEANNE M CUSH
K010306 10/03/2001 MEDCOMP EXCELL SPLIT TIP CATHETER MEDCOMP JEANNE M CUSH
K994105 10/03/2001 HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40 MEDICAL COMPONENTS, INC. JEANNE M CUSH
K012336 10/03/2001 MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500 MEDICAL DATA ELECTRONICS GREGORY R ALKIRE
K012632 10/26/2001 TOURNIQUET CUFF; PNEUMATIC TOURNIQUET MEDICAL INSTRUMENTS TECHNOLOGY, INC. JACK SPEER
K012950 10/04/2001 MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM MEDRAD, INC. LORRAINE R FREDES
K011080 10/11/2001 BRIDGE SE SELF-EXPANDING STENT DELIVERY SYSTEM MEDTRONIC AVE, INC. JOHN RIOLO
K012143 10/24/2001 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524 MEDTRONIC CARDIAC SURGICAL PRODUCTS MELISSA HARRIGER
K010528 10/10/2001 TITANIUM CEMENT RESTRICTOR MATERIAL PEEK MEDTRONIC SOFAMOR DANEK USA, INC. RICHARD W TREHARNE
K013014 10/04/2001 BLOCK CEMENT RESTRICTOR (CR) - TITANIUM MEDTRONIC SOFAMOR DANEK, INC. RICHARD W TREHARNE
K012081 10/01/2001 DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K010930 10/24/2001 LIFT VB SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K004005 10/12/2001 MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED) MENTOR CORP. DONNA A CRAWFORD
K012240 10/15/2001 MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE MERCAN AB JEFFREY O STULL
K012237 10/15/2001 MERTEX-PLUS REUSABLE SURGICAL DRAPE MERCAN AB JEFFERY O STULL
K010586 10/30/2001 PALAMED BONE CEMENT MERCK BIOMATERIAL GMBH THOMAS KIEWITT
K011058 10/23/2001 TELEPRESS III BLOOD PRESSURE MONITOR, MODEL TPIII MERIDIAN MEDICAL TECHNOLOGIES LTD. RHONA LOVE
K013192 10/17/2001 SONICATOR PLUS 930, MODEL ME 930 METTLER ELECTRONICS CORP. ROBERT E FLEMING
K011392 10/22/2001 MICRA LENS INJECTOR, MICRA CARTRIDGE LENS, MICRA LENS LOADER MICRA INSTRUMENTS JOHN A.K. BASKERVILLE
K011952 10/25/2001 DRUGS OF ABUSE MULTI-TEST STRIP MICRODIAGNOSTICS, INC. JUNE SHOZI
K012868 10/29/2001 MICROMEDICS FIBRIJET AEROSOL APPLICATOR MICROMEDICS, INC. CHARLES GROTE
K011318 10/25/2001 VENODYNE DVT ADVANTAGE PLUS MICROTEK MEDICAL, INC. TOM BONNER
K012145 10/29/2001 MICROPLEX COIL SYSTEM MICROVENTION, INC. VINCENT CUTARELLI
K013322 10/16/2001 HAC-420 HEAD ARRAY COIL MRI DEVICES CORP. TOM SCHUBERT
K013159 10/16/2001 HRH-63-8 HEAD ARRAY COIL MRI DEVICES CORP. TOM SCHUBERT
K012263 10/10/2001 MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024 NATIONAL CUSTOM ENT., INC. DON PELLETIER
K012264 10/10/2001 MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC NATIONAL CUSTOM ENT., INC. DON PELLETIER
K012522 10/18/2001 WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL NATIONAL THERAPY PRODUCTS INC. PAUL L HOOEY
K013137 10/16/2001 ALGO 3 NEWBORN HEARING SCREENER NATUS MEDICAL, INC. SHEILA RAMERMAN
K012982 10/02/2001 COOLTOUCH VARIZOOM NEW STAR LASERS, INC. DONALD V JOHNSON
K012367 10/09/2001 VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D NICHOLS INSTITUTE DIAGNOSTICS JIMMY WONG
K012416 10/26/2001 CONFOSCAN 2 CONFOCAL MICROSCOPE NIDEK TECHNOLOGIES SRL CAROL PATTERSON
K010053 10/23/2001 HUMI-FLOW, MODEL 6-850-00/ 01/02 NORTHGATE TECHNOLOGIES, INC. CASEY KUREK
K012508 10/09/2001 MU PHOTONICS PAIN THERAPIST NU PHOTONICS, INC. WILLIAM M BROCK
K010032 10/17/2001 SEED SELECTRON MODEL V. 1.0 NUCLETRON CORP. RALPH E SHUPING
K013257 10/30/2001 HEMI-ARC SURGICAL NAVIGATOR NUVASIVE, INC. LAETITIA BERNARD
K013215 10/16/2001 MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM NUVASIVE, INC. SEAN M CURRY
K012832 10/24/2001 COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200 NXSTAGE MEDICAL, INC. KAREN ST. ONGE
K012510 10/19/2001 MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM NXSTAGE MEDICAL, INC. KAREN ST.ONGE
K010613 10/12/2001 MAGELLAN-2200, MODEL 1 OCEANIC MEDICAL PRODUCTS, INC. WILLIAM M GATES
K012425 10/12/2001 BIOMEDICS UV MULTIFOCAL OCULAR SCIENCES PUERTO RICO, INC. RICHARD LIPPMAN
K012402 10/12/2001 OMNI GRACE LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM OMNIGRACE (THAILAND) LTD. WILLIAM E PATTON
K012227 10/01/2001 MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1 ONCOLOGY DATA SYSTEMS, INC. GREGORY G MILLER
K012254 10/16/2001 VBR OSTEOTECH, INC. KIM THURMAN
K012238 10/01/2001 DOSERIGHT PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. FRANK GIANELLI
K012509 10/09/2001 PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEM PHOENIX DIAGNOSTICS, INC. RAM NUNNA
K012475 10/24/2001 CAAS II QVA PIE MEDICAL IMAGING B.V. CARLA DE VRIES
K013173 10/22/2001 BIOSCANNER PLUS; LIPID PANEL TEST STRIPS POLYMER TECHNOLOGY SYSTEMS, INC. MARGO ENRIGHT
K012809 10/26/2001 SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU - 45MM, MODEL RALC45 POWER MEDICAL INTERVENTIONS, INC. LAURENCE A POTTER
K012142 10/04/2001 THE QUIET SLEEPER PRECISION DENTAL LABORATORIES, INC. SHARON LAMONT
K012673 10/24/2001 PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM PRIME DENTAL MANUFACTURING, INC. ROLANDO MARASIGAN
K012629 10/05/2001 ALWAYS DUETS PROCTER & GAMBLE CO. MARK M ANDERSON
K012709 10/01/2001 POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (GREEN) QINGDAO BESTEX RUBBER & PLASTIC PRODUCTS CO., LTD ZECHUAN SHAO
K012315 10/11/2001 LEVEEN ELECTRODE RADIOTHERAPEUTICS CORP. KIRSTEN VALLEY
K011046 10/25/2001 AUTOPULSE, MODEL 100 REVIVANT CORP. BOB KATZ
K013129 10/10/2001 RHODIA DENTAL PUTTY IMPRESSION MATERIAL RHODIA INC. ALAIN MORIN
K013140 10/10/2001 RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL RHODIA INC. ALAIN MORIN
K012848 10/25/2001 WINNER CM4 COMBINATION UNIT RICH-MAR CORP. DAVID RICHARDS
K012309 10/19/2001 RIWO SYSTEM TRAYS RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K012121 10/24/2001 SECUREGUARD RETRACTABLE SAFETY SYRINGE SAFEGARD MEDICAL PRODUCTS, INC. MIKE DAYTON
K012283 10/01/2001 SOLOGARD LOCKING PLUS SYRINGE WITH NEEDLE SAFEGARD MEDICAL PRODUCTS, INC. PATRICK GRANT, JR.
K011470 10/12/2001 SDI SB OFFICE, MODEL 29- SDI DIAGNOSTICS, INC. MICHAEL J BOYLE
K012935 10/11/2001 THECURVE, ITEM 507 SELECT MEDICAL SYSTEMS, INC. MONIQUE GIRARD
K012786 10/01/2001 POWDERFREE NITRILE NEOPRENE EXAMINATION GLOVES (PULPLE) SHAMROCK MANUFACTURING COMPANY EMMY TJOENG
K012339 10/16/2001 ENVIORN-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW SHANGHAI ANTARES INDUSTRIES, INC. JOHN LAI
K012499 10/16/2001 ENVIRON-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES SHANGHAI ANTARES INDUSTRIES, INC. JOHN LAI
K012772 10/01/2001 CTS-485 ULTRASOUND IMAGING SYSTEM SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS ROBERT MORTON
K012710 10/04/2001 DISPOSABLE POWDERED VINYL EXAMINATION GLOVES SHIJIAZHUANG BRILLIANCE PLASTIC CO., LTD. HUAN CHUNG-LI
K012424 10/18/2001 SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM SHIMADZU CORP. MICHAEL FISHBACK
K011476 10/30/2001 SOVEREIGN SHOPRIDER INTL., INC. CHRIS TINSLEY
K012495 10/31/2001 OR TABLE AND HEADHOLDER/MAGNETOM HARMONY, SYMPHONY, SONATA SYSTEMS SIEMENS MEDICAL SOLUTIONS USA, INC. JAMIE YIEH
K013121 10/15/2001 MT ALERT INFUSION MONITOR SIERRA BIOSEARCH INC RICHARD CITRENAUM
K012410 10/26/2001 INFINITY HBA KIT, MODELS 537-A, 537-B SIGMA DIAGNOSTICS, INC. WILLIAM R GILBERT II
K012453 10/22/2001 SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY) SODEM SYSTEMS CAROLE BURNIER
K012457 10/22/2001 SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY) SODEM SYSTEMS CAROLE BURNIER
K012949 10/04/2001 URETEX SUP PUBOURETHRAL SLING SOFRADIM PRODUCTION MARY MCNAMARA-CULLINANE
K012859 10/26/2001 NU-SPEC D SOL WEISS MD INC SOL WEISS
K012505 10/05/2001 SOPRO595 INTRA ORAL CAMERA SOPRO PIERRE MONTILLOT
K012528 10/22/2001 ICE SOUTHERN DENTAL INDUSTRIES, LTD. SAMANTHA J CHEETHAM
K012529 10/22/2001 ROK SOUTHERN DENTAL INDUSTRIES, LTD. SAMANTHA J CHEETHAM
K012427 10/09/2001 PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT SPECIALITES SEPTODONT PETER S REICHERTZ
K013029 10/09/2001 SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515 ST. JUDE MEDICAL JIM M TAUFEN
K012807 10/11/2001 MODIFICATION TO: COMPEL SURGICAL DRAPES STANDARD TEXTILE CO., INC. BRADLEY J BUSHMAN
K003857 10/18/2001 STERILMED INTERMITTENT COMPRESSION SYSTEM, GARMENT MODELS 400 SERIES STERILMED, INC. PATRICK FLEISCHHACKER
K013104 10/02/2001 SIMPLICITY QD SOFT INFUSION SET FOR USE BY PEOPLE WITH DIABETES IN INFUSE INSULIN SUBCUTANEOUSLY FROM A PUMP OR SYRINGE STERLING MEDIVATIONS, INC. JOEL DOUGLAS
K012011 10/10/2001 MODIFICATION TO A620 EEG STOELTING CO. KENNETH L BIRD
K013059 10/22/2001 STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES) STONY BROOK SURGICAL INNOVATIONS, INC. SUSAN D GOLDSTEIN-FALK
K012961 10/18/2001 SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM SULZER ORTHOPEDICS, INC. MITCHELL A DHORITY
K011913 10/26/2001 SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES SUN-RAIN SYSTEM CORP. YANG TIEN-HISING
K013009 10/03/2001 BELLEGLASS HP DC OPACEOUS DENTIN LCTE 2 SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K013007 10/01/2001 BELLEGLASS HP ENAMEL 2 SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K012717 10/25/2001 LIFE 2 SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K013008 10/02/2001 NEXUS 2 MODIFIED SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K013164 10/15/2001 SURSHIELD SAFETY WINGED BLOOD COLLECTION SET TERUMO MEDICAL CORP. BARBARA SMITH
K011283 10/15/2001 MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE THE KENDALL COMPANY DAVID A OLSON
K012218 10/12/2001 LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES THE LUDLOW COMPANY LP KATHLEEN M TREMBLAY
K012462 10/29/2001 THEKEN LARGE CEMENT RESTRICTOR THEKEN SURGICAL,LLC RANDY THEKEN
K012278 10/17/2001 THEKEN SMALL CEMENT RESTRICTOR THEKEN SURGICAL,LLC RANDY THEKEN
K013034 10/04/2001 MODIFICATION TO: THERMACOOL IIA THERMAGE, INC. PAMELA M BUCKMAN
K012525 10/04/2001 THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235 THERMO DMA, INC. THOMAS DOLLAR
K012878 10/16/2001 THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609 THERMO DMA, INC. THOMAS DOLLAR
K012518 10/09/2001 TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113 THERMO DMA, INC. THOMAS DOLLAR
K013202 10/23/2001 MODIFICATION TO BRAIDED GUIDING INTRODUCER THOMAS MEDICAL PRODUCTS, INC. TIM STOUDT
K013279 10/18/2001 MOSFET AUTOSENSE, MODEL TN-RD-60 THOMSON & NIELSEN ELECTRONICS, LTD. NORMA THOMSON
K013286 10/12/2001 CYMUNVERA POWDER FREE GREEN NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE LINED WITH ALOE VERA TILLOTSON HEALTHCARE CORP. THOMAS N TILLOTSON
K013016 10/19/2001 TRUE ADVANTAGE NON-STERILE POWDER FREE PURPLE NITRILE EXAMINATION GLOVE TILLOTSON HEALTHCARE CORP. F. W PERRELLA
K002512 10/15/2001 TORAYSULFONE DIALYZER TORAY INDUSTRIES (AMERICA), INC. LISA S JONES
K013214 10/05/2001 CEREBRAL BLOOD FLOW ANALYSIS SYSTEM (CBP), MODEL NUMBER CSCP-001A TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K012895 10/30/2001 HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KAPP
K991810 10/09/2001 MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K012736 10/25/2001 MONOJECT SAFETY NEEDLE TYCO HEALTHCARE DAVID A OLSON
K012592 10/03/2001 EASYTRAVEL TZORA ACTIVE SYSTEMS LTD. YOEL ETZIONI
K013150 10/18/2001 MR-GUIDE 2000 ULTRAGUIDE LTD. GEORGE MYERS
K012144 10/01/2001 CYTOFLEX UNICARE BIOMEDICAL, INC. STAN YANG
K012346 10/16/2001 VANGUARD REPROCESSED ARTHROSCOPIC BLADES VANGUARD MEDICAL CONCEPTS, INC. MIKE SAMMON
K012695 10/30/2001 VANGUARD REPROCESSED ARTHROSCOPIC WANDS VANGUARD MEDICAL CONCEPTS, INC. MIKE SAMMON
K012403 10/17/2001 VANGUARD REPROCESSED COMPRESSION GARMENT VANGUARD MEDICAL CONCEPTS, INC. MICHAEL SAMMON
K011049 10/01/2001 EXPRESSSUITE VIDAR SYSTEMS CORP. MARY HARP
K012636 10/26/2001 BPTRU AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100 VSM TECHNOLOGY, INC. DARYL WISDAHL
K013250 10/26/2001 GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT W. L. GORE & ASSOCIATES, INC. TIMOTHY J RYNN
K012409 10/18/2001 LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS WALTER LORENZ SURGICAL, INC. SHERYL MALMBERG
K012791 10/24/2001 C.T.M. MOBILITY SCOOTER MODEL # HS-320 WAREPALMY ENTERPRISE LLC (USA) ROBERT S MCQUATE
K012792 10/24/2001 C.T.M. MOBITIY SCOOTER MODEL #HS-360 WAREPALMY ENTERPRISE LLC (USA) ROBERT S MCQUATE
K012838 10/23/2001 ERO50, ORDER-NO.: 2070 WIELAND EDELMETALLE GMBH & CO. GERHARD POLZER
K012840 10/23/2001 EURO 45, ORDER-NO.: 2064 WIELAND EDELMETALLE GMBH & CO. GERHARD POLZER
K012065 10/10/2001 WIENER LAB. CREATININA CINETICA AA WIENER LABORATORIES S.A.I.C. VIVIANA CETOLA
K013356 10/19/2001 WILSON-COOK ULTRASOUND BIOPSY NEEDLE WILSON-COOK MEDICAL, INC. MARGARET J POSNER
K010532 10/26/2001 OSTEOSET BVF KIT WRIGHT MEDICAL TECHNOLOGY, INC. EHAB M ESMAIL
K012091 10/03/2001 PRO-FEMUR WRIGHT MEDICAL TECHNOLOGY, INC. EHAB M ESMAIL
K012876 10/01/2001 DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) WRP SPECIALTY PRODUCTS SDN. BHD. MOHD HAIZAN HUSSEIN
K011021 10/09/2001 LASER 20 YA-MAN LTD ROBERT T HANDREN
K013025 10/03/2001 MODIFICATION TO FLOUROLAB PLUS Z-KAT, INC. WILLIAM F TAPIA


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