FDA 510(k) Decisions During November, 1996  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K961665 11/15/1996 "O" BUTMENT ET IMPLANT "O" CO., INC. DAVID D DALISE
K963677 11/26/1996 9TH WAVE MODEL 200 ALTERNATING PRESSURE PAD 9TH WAVE, INC. JEAN ROZINT
K963626 11/26/1996 9TH WAVE MODELS 400 & 450 ALTERNATING PRESSURE MATTRESS 9TH WAVE, INC. JEAN ROZINT
K963610 11/27/1996 AKI COMPACS DATA COMPRESION MODULE FOR DIAGNOSTIC IMAGES A.L.I. TECHNOLOGIES, INC. ROBERT MACNEIL
K962633 11/04/1996 VEGA HEMATOLOGY ANALYZER ABX, INC. BRICE PROUVE
K963639 11/14/1996 ACROMED PEDICLE SCREW ACROMED CORP. WILLIAM CHRISTIANSON
K962984 11/27/1996 ISOLA PEDIATRIC COMPONENTS ACROMED CORP. WILLIAM CHRISTIANSON
K963656 11/12/1996 FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING ADRI GEORGE H SCHERR
K963211 11/22/1996 UNISEAL GLOVES (LOW PROTEIN,POWDER FREE) AMERICAN HEALTHCARE PRODUCTS, INC. TONY DJIE
K963911 11/01/1996 ALPCO/MERCODIA INSULIN ELISA AMERICAN LABORATORY PRODUCTS CO., LTD. RICHARD CONLEY
K962052 11/15/1996 ORGENTEC ABTI-SS-BB(LA) ELISA AMERICAN LABORATORY PRODUCTS CO., LTD. RICHARD CONLEY
K962053 11/15/1996 ORGENTEC ANTI-JO-1 ELISA AMERICAN LABORATORY PRODUCTS CO., LTD. RICHARD CONLEY
K962057 11/18/1996 ORGENTEC ANTI-RNP/SM ELISA AMERICAN LABORATORY PRODUCTS CO., LTD. RICHARD CONLEY
K962055 11/15/1996 ORGENTEC ANTI-SCL 70 ELISA AMERICAN LABORATORY PRODUCTS CO., LTD. RICHARD CONLEY
K962062 11/18/1996 ORGENTEC ANTI-SM ELISA AMERICAN LABORATORY PRODUCTS CO., LTD. RICHARD CONLEY
K962054 11/15/1996 ORGENTEC ANTI-SS-A(RO) ELISA AMERICAN LABORATORY PRODUCTS CO., LTD. RICHARD CONLEY
K963389 11/26/1996 FLEX-LASE 600 SERIES ION LASER SYSTEM AMERICAN LASER MEDICAL DANIAL HOEFER
K943824 11/01/1996 GASEOUS OXYGEN ANALYZER (MODEL S-3A) MODIFICATION AMETEK, INC. JOE VELTRY
K961460 11/19/1996 LWEET CONE BIOPSY INSTRUMENT APPLE MEDICAL CORP. RANDOLPH L COOKE
K962668 11/04/1996 AMR-ACV CLAMPS APPLIED MEDICAL RESOURCES HOWARD V ROWE
K961710 11/01/1996 AOC MEDICAL SYSTEM MODEL PHASE II 25 SURGICAL DIODE LASER SYSTEM APPLIED OPTRONICS CORP. DOUGLASS MEAD
K961705 11/01/1996 AOC MEDICAL SYSTEM MODEL PHASE II 50 SURGICAL DIODE LASER SYSTEM APPLIED OPTRONICS CORP. DOUGLASS MEAD
K963742 11/20/1996 LATEX EXAMINATION GLOVES, POWDERED ARISTA MEDI PRIMA CHAIRINA BREDER
K963879 11/26/1996 AHS DELTA 22 AUTHORIZED HEARING SYSTEMS, INC. HENRY SMITH
K963881 11/26/1996 AHS DELTA 22 T AUTHORIZED HEARING SYSTEMS, INC. HENRY SMITH
K963874 11/26/1996 AHS OMEGA AGC AUTHORIZED HEARING SYSTEMS, INC. HENRY SMITH
K963873 11/26/1996 AHS OMEGA DEQ AUTHORIZED HEARING SYSTEMS, INC. HENRY SMITH
K963875 11/27/1996 AHS OMEGA K-AMP AUTHORIZED HEARING SYSTEMS, INC. HENRY SMITH
K963876 11/26/1996 AHS OMEGA PP AUTHORIZED HEARING SYSTEMS, INC. HENRY SMITH
K963964 11/29/1996 AVL COMPACT 3 PH/BLOOD GAS ANALYZER AVL SCIENTIFIC CORP. RANDY BYRD
K963484 11/19/1996 BARD HIGH FLOW PAPILLOTOME BARD INTERVENTIONAL PRODUCTS DIV. BETH A ROCHETTE, R.A.C.
K963496 11/26/1996 OXI TEMP BCI INTL., INC. DONALD J ALEXANDER
K963138 11/06/1996 SPIDER STRAP BDM MEDICAL, INC. BONNIE J BURLAGE
K963061 11/04/1996 IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT BECKMAN INSTRUMENTS, INC. ANNETTE HELLIE
K963048 11/04/1996 IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT BECKMAN INSTRUMENTS, INC. ANNETTE HELLIE
K954923 11/21/1996 BACTEC FUNGAL MEDIUM BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS DAVID R MERTZ
K964062 11/21/1996 N PROTEIN STRANDARD SL BEHRING DIAGNOSTICS, INC. LAURA LEBARRON
K964065 11/06/1996 N/T PROTEIN CONTROL SL BEHRING DIAGNOSTICS, INC. LAURA LEBARRON
K963955 11/19/1996 DR. BERT'S SUNCARE PRODUCTS PEEPER KEEPERS BERT & JOE'S, INC. ALBERT K PIERCE
K964213 11/25/1996 TRACE RITE SOLID GEL ECG ELECTRODES BIO-DETEK, INC. MICHAEL R DUPELLE
K963697 11/27/1996 ADVANCED DIAGNOSTIC VIEWER (ADV) BIO-VASCULAR, INC. BRUCE A MACFARLANE, PH.D.
K961566 11/18/1996 BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS BIOCIRCUITS CORP. SHEILA J RAMERMAN
K960267 11/05/1996 TBM SPONGE BIOCOLL LABORATORIES, INC. ED RANSON
K962706 11/13/1996 EZ-FIX CANNULATED SCREW SYSTEM BIODYNAMIC TECHNOLOGIES, INC. DANNY HODGEMAN
K962987 11/04/1996 EZ-FIX SMALL CANNULATED SCREW SYSTEM BIODYNAMIC TECHNOLOGIES, INC. DANNY HODGEMAN
K964073 11/14/1996 BME BONE DRILL BITS BIOMEDICAL ENT., INC. W. CASEY FOX
K960856 11/27/1996 KONSTRUCT PATELLAR COMPONENT BIOMET, INC. MARY L VERSTYNEN
K963462 11/21/1996 COMFOR FOAM LIMB HOLDERS- SINGLE STRAP BIRD & CRONIN, INC. MICHAEL FRAZER
K964000 11/05/1996 BISFIL 2B BISCO, INC. JAMES L SANDRIK
K963215 11/14/1996 CLAMPLESS VALVED CATHETER - MIDLINE (CVC-ML) BMW MEDICAL, INC. PHIL TRIOLO
K963840 11/20/1996 CEDIA PHENYTOIN II ASSAY BOEHRINGER MANNHEIM CORP. YVETTE LLOYD
K962760 11/29/1996 ENZYMUN-TEST FT3 BOEHRINGER MANNHEIM CORP. JOHN D STEVENS
K963187 11/04/1996 MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930 - 940, 30 - 40 CC SENSATION AND NICATH 30C BOSTON SCIENTIFIC CORP. LEO BASTA
K963750 11/22/1996 RETRIEVAL SNARE BOSTON SCIENTIFIC CORP. LISA M QUAGLIA
K963226 11/15/1996 SURGICAL FABRICS BOSTON SCIENTIFIC CORP. LORRAINE M HANLEY
K963397 11/25/1996 ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. MARY P LEGRAW
K963241 11/14/1996 ULTRAFLEX BOSTON SCIENTIFIC CORP. DANIEL J DILLON
K961999 11/19/1996 SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS BOSTON SCIENTIFIC SCIMED, INC. MARIA BRITTLE
K963682 11/13/1996 "GENIE' SINGLE CEILING AND DOUBLE CEILING BURTON MEDICAL PRODUCTS CORP. GRETEL LUMLEY
K963260 11/22/1996 DRESSING CHANGE TRAYS BUSSE HOSPITAL DISPOSABLES, INC. EILEEN RAMA
K962911 11/29/1996 CONTACT LENS WITH COLOR ADDITIVE CAL BIONICS HARBO P JENSEN, PH.D.
K963954 11/25/1996 CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY CALTAG LABORATORIES, INC. DAVID C BISHOP
K963183 11/26/1996 BIOZ SYSTEM CARDIODYNAMICS INTERNATIONAL CORP. JAMES BARLEY
K963927 11/15/1996 TEAM CARIES INDICATOR CENTRIX, INC. JOHN DISCKO
K960615 11/25/1996 GAUZE COMPRESS CERTIFIED SAFETY MFG., INC. HOWARD GERSON
K962559 11/05/1996 ACS CORTISOL IMMUNOASSAY CIBA CORNING DIAGNOSTICS CORP. THOMAS F FLYN
K963487 11/27/1996 DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENS CIBA VISION CORPORATION ALICIA M PLESNARSKI
K964278 11/22/1996 WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6 CLINICAL CONTROLS, INC. JAMES F GODFREY
K962364 11/08/1996 CODONICS MEDICAL PRINTER (NP-1600M,NP1600MD) CODONICS, INC. PETER BOTTEN
K962113 11/05/1996 ANTHOS PHACTS VERSION MICROPLATE READER COLUMBIA BIOSCIENCE, INC. NORMAN JENKINS
K963453 11/15/1996 CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046) CONTOUR FABRICATORS, INC. MICHAEL CZOP
K961668 11/04/1996 MICROFERRET CATHETER COOK, INC. APRIL LAVENDER
K954311 11/19/1996 KOH COLPOTOMIZER SYSTEM COOPERSURGICAL, INC. MARY M MCNAMARA
K963171 11/07/1996 CINCH QR SGW EXTENSION CORDIS CORP. LISA WELLS
K963214 11/13/1996 CORDIS ST STEERABLE GUIDEWIRE CORDIS CORP. LISA WELLS
K963046 11/01/1996 ENDOCAM CORIN U.S.A. JACK THOMAS
K964011 11/25/1996 SUCTION CATHETER TRAY PRODUCT NO. 900277 CUSTOMED, INC. OSVALDO RODRIGUEZ
K964565 11/22/1996 PARAMAX AMMONIA AND AMMONIA BLANK REAGENT DADE INTL., INC. MARIAN HARDING COCHRAN, EQS.
K960868 11/14/1996 B.A.S.I.C. DENTAL IMPLANT SYSTEM DANLIN PRODUCTS, INC. DAN BLACKLOCK
K961509 11/15/1996 INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED DATASCOPE CORP. FRANK CASAMASSINA
K964204 11/13/1996 ENGSTROM HMEF 1000 DATEX ENGSTROM AB PAUL E DRYDEN
K960770 11/19/1996 MATCHMAKER/PROPAQUE PORCELAIN DAVIS SCHOTTLANDER & DAVIS, LTD. B.D. SCHOTTLANDER
K963628 11/07/1996 IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE DEJARNETTE RESEARCH SYSTEMS WAYNE T DEJARNETTE
K963592 11/07/1996 IMAGESHARE PROTOCOL CONVERTING GATEWAY AND/OR SOFTWARE [OS/2 WARP] 1OOO,[SUN/SOLARIS] 2000 DEJARNETTE RESEARCH SYSTEMS WAYNE T DEJARNETTE, PH.D.
K963594 11/07/1996 IMAGESHARE SECONDARY CAPTURE ACQUISITION STATION AND/OR SOFTWARE (1000 FILM DIGITIZER ACQUISITION STATION) DEJARNETTE RESEARCH SYSTEMS WAYNE T DEJARNETTE, PH.D.
K963098 11/08/1996 PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100) DEKNATEL, INC. DEAN E CIPORKIN
K963309 11/12/1996 APEX HOLE ELIMINATOR PS DEPUY, INC. CHERYL HASTINGS
K963350 11/14/1996 DEPUY MOTECH PEAK FIXATION SYSTEM DEPUY, INC. CHERYL HASTINGS
K955733 11/18/1996 HYLOC INTERFERENCE SCREW (CANNULATED)/(NON-CANNULATED) DEPUY, INC. STEVEN J WENTWORTH
K963603 11/27/1996 DERMAGRAN HYDROPHILIC OINTMENT DERMA SCIENCES, INC. MARK G CLARK
K962089 11/05/1996 DERMAMEND GEL DERMARX CORP. MARYANNE CARROLL
K963470 11/14/1996 CRISS-CROSS VEST RESTRAINT DEROYAL INDUSTRIES, INC. CAMILLE MATLOCK
K963469 11/14/1996 MITTENS DEROYAL INDUSTRIES, INC. CAMILLE MATLOCK
K963477 11/12/1996 PEDIATRIC MITTENS DEROYAL INDUSTRIES, INC. CAMILLE MATLOCK
K963472 11/14/1996 PEDIATRIC VEST RESTRAINT DEROYAL INDUSTRIES, INC. CAMILLE MATLOCK
K963464 11/12/1996 RESTRAINT NET DEROYAL INDUSTRIES, INC. CAMILLE MATLOCK
K963473 11/14/1996 REUSABLE LIMB HOLDER DEROYAL INDUSTRIES, INC. CAMILLE MATLOCK
K963478 11/14/1996 SLEEVED/SLEEVELESS VEST RESTRAINT DEROYAL INDUSTRIES, INC. CAMILLE MATLOCK
K963471 11/14/1996 SUPER SECURITY RESTRAINT DEROYAL INDUSTRIES, INC. CAMILLE MATLOCK
K963245 11/18/1996 IMMULITE LATEX-SPECIFIC IGE DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K964108 11/18/1996 FACT PLUS PREGNANCY TEST DIRECT ACCESS DIAGNOSTICS MARYLOU PANICO
K963909 11/08/1996 HEMOCUE GLUCOLIN DIRECT SOLUTIONS BILL DONOHUE
K964053 11/01/1996 HEMOCUE GLUCOTROL DIRECT SOLUTIONS BILL DONOHUE
K964052 11/06/1996 HEMOCUE HEMOTROL DIRECT SOLUTIONS BILL DONOHUE
K950853 11/05/1996 OPTIONAL DISPLAY AND SOFTWARE FOR DRAGER VENTILATORS DRAGER, INC. HARALD KNEUER
K963162 11/12/1996 QUANTEM ELSCINT, INC. THOMAS J SPACKMAN, M.D.,F.A.C.R.
K961656 11/26/1996 TEST-MATE CHE CHOLINESTERASE TEST SYSTEM EQM RESEARCH, INC. J. PATRICK EBERLY
K963189 11/26/1996 ERBE APC 300 ARGON PLASMA COAGULATOR AND ACCESSORIES - ARGON PLASMA COAGULATOR AND ACCESSORIES ERBE USA, INC. SUSAN D GOLDSTEIN-FALK
K963434 11/25/1996 VISCOUS FLUID SYSTEM ESCALON TREK MEDICAL RONALD L HUENEKE
K963735 11/27/1996 COJET SYSTEM ESPE GMBH & CO. KG. BARBARA WAGNER
K963737 11/15/1996 HYCEM APLICAP ESPE GMBH & CO. KG. BARBARA WAGNER
K962584 11/04/1996 ULTRACISION 5MM HARD SHEATH LAPAROSONIC BLADE ETHICON ENDO-SURGERY, INC. LONNIE PACE
K963783 11/25/1996 MITEK ELECTROSURGICAL SYSTEM FOR ARTHROSCOPIC USE ETHICON, INC. EDWARD F KENT
K964413 11/25/1996 SUNGLASSES(NON-PRESCRIPTION) EVER PRIME ENTERPRISES LTD. YAN YAT CHIU
K963313 11/14/1996 EXACTECH ALL POLY ACETABULAR CUP EXACTECH, INC. MARTHA MILLER
K962631 11/26/1996 DEXIS MODEL 601 DENTAL ELECTRONIC IMAGING SYSTEM FAIR IMAGE, INC. DAVID W SCHLERF
K955775 11/15/1996 SAFECONNECT VALVE (CATALOG NO. XXXX) FAULDING MEDICAL DEVICE CO. BRUCE CRANEY
K964087 11/25/1996 BLOCK STOP WIRES FERGUSON MEDICAL FRANK FERGUSON
K964094 11/27/1996 MINIFIX FERGUSON MEDICAL FRANK FERGUSON
K963034 11/01/1996 FEMTEX GENTLE TOUCH TAMPONS FIRST QUALITY HYGIENIC, INC. ROBERT J STAAB, PH.D.
K963124 11/08/1996 PC LASER WITH SMART PLUG (PC EDO & DENTAL 200) FISMA, INC. DOUGLAS A KANE
K955749 11/22/1996 TEX-CARE STERILE STOCKINETTE FLYNT AMTEX, INC. JOHN A KRANASKAS
K962116 11/27/1996 GALILEO ENDOSCOPES GALILEO ELECTRO-OPTICS CORP. MARY MCNARMARA-CULLINANE
K962568 11/25/1996 "ACRI" ILIAC CREST ASPIRATION BIOPSY NEEDLES GALLINI INTL., INC. CATERINA E GALLUZZO
K962570 11/27/1996 "ISAN" STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE GALLINI INTL., INC. CATERINA E GALLUZZO
K962569 11/27/1996 BIOMID BONE MARROW BIOPSY NEEDLE GALLINI INTL., INC. CATERINA E GALLUZZO
K961407 11/21/1996 SPEED-CUT GALLINI INTL., INC. CATERINA ELENA GALLUZZO
K964465 11/26/1996 LA PLATA 34 (PM-25) GATEWAY ALLOYS, INC. JOHN C CONSTANTINE
K964478 11/26/1996 OSAGE 76 GATEWAY ALLOYS, INC. JOHN C CONSTANTINE
K964464 11/26/1996 PACIFIC 52 (CB-39) GATEWAY ALLOYS, INC. JOHN C CONSTANTINE
K964466 11/20/1996 PALLADIA 75 (PM-11) GATEWAY ALLOYS, INC. JOHN C CONSTANTINE
K962061 11/27/1996 MAGNETIC RESONANCE DIAGNOSTIC SYSTEM GE MEDICAL SYSTEMS LARRY A KROGER
K963179 11/07/1996 MAGNETIC RESONANCE DIAGNOSTIC SYSTEM GE MEDICAL SYSTEMS LARRY A KROGER
K963429 11/27/1996 MAGNETIC RESONANCE DIAGNOSTIC SYSTEM GE MEDICAL SYSTEMS LARRY A KROGER
K962217 11/27/1996 GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT GEN-PROBE, INC. GERALD H SCHELL
K962816 11/26/1996 SPERM PREPARATION MEDIA GENX INTL., INC. MICHAEL D CECCHI
K964155 11/25/1996 CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST GENZYME DIAGNOSTICS DELIA R BETHELL
K964156 11/25/1996 CONTRAST STRIP HCG GENZYME DIAGNOSTICS DELIA R BETHELL
K962821 11/13/1996 EPIDURAL ANESTHESIA KIT AND COMBINED SPINAL EPIDURAL ANESTHESIA KIT GLOBAL MEDICAL PRODUCTS, LTD. PETER M CLARK
K963719 11/27/1996 CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY GRAND MEDICAL PRODUCTS HARVEY WEISS
K963715 11/27/1996 DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY GRAND MEDICAL PRODUCTS HARVEY WEISS
K963724 11/29/1996 GAUZE SPONGE, NON X-RAY DETECTABLE GRAND MEDICAL PRODUCTS HARVEY WEISS
K963714 11/27/1996 GRAND MEDICAL SUTURE REMOVAL KIT GRAND MEDICAL PRODUCTS HARVEY WEISS
K963722 11/27/1996 IV START KIT GRAND MEDICAL PRODUCTS HARVEY WEISS
K963723 11/27/1996 LACERATION TRAY GRAND MEDICAL PRODUCTS HARVEY WEISS
K963721 11/27/1996 SKIN SCRUB TRAY GRAND MEDICAL PRODUCTS HARVEY WEISS
K963720 11/27/1996 TRACHEOSTOMY KIT GRAND MEDICAL PRODUCTS HARVEY WEISS
K963038 11/15/1996 MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODE GRAPHIC CONTROLS CORP. KATHLEEN SELOVER
K963151 11/19/1996 MEDI-TRACE 5700 RESTING ECG ELECTRODE GRAPHIC CONTROLS CORP. SUSAN KRASNY
K962482 11/01/1996 SCUBA SYSTEM GYNECARE, INC. MILTON B MCCOLL, M.D.
K963745 11/26/1996 MODEL WMR BTE HEARING INSTRUMENT (MODEL WMR) HEARING INNOVATIONS, INC. ROBERT S GREEN
K964180 11/26/1996 AUDIO 'D' SOUND SELECTOR POWER (SSP) HEARING SOLUTIONS, INC. EDOUARD A GAUTHIER
K962366 11/07/1996 HEARTPORT CABLE BULLDOG CLAMP HEARTPORT, INC. ISABELLA R ABATI, M.S.
K961334 11/15/1996 HEARTPORT HANDSWITCH ELECTROCAUTERY PROBE HEARTPORT, INC. ISABELLA R ABATI
K961333 11/15/1996 HEARTPORT MULTIFIRE CLIP APPLIER HEARTPORT, INC. ISABELLA R ABATI
K963372 11/07/1996 HEELBO ER WRIST RESTRAINT HEELBO, INC. JOSEPH S TOKARZ
K963099 11/01/1996 HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKET HEELBO, INC. JOSEPH S TOKARZ
K963060 11/04/1996 HEELBO SECURITY BELT HEELBO, INC. JOSEPH S TOKARZ
K962128 11/21/1996 TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT) HEMO SAPIENS, INC. B. BO SRAMEK
K964140 11/05/1996 GLUMA CONDITIONER HERAEUS KULZER, INC. CHERYL V ZIMMERMAN
K963199 11/01/1996 HEELBO PELVIC RESTRAINT HOLLISTER, INC. JOSEPH S TOKARZ
K962537 11/27/1996 INCARE HOT/ICE LITE MACHINE HOLLISTER, INC. JOSEPH S TOKARZ
K963363 11/22/1996 HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS HOLOGIC, INC. ERIC VON STETTEN, PH.D.
K960855 11/07/1996 PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS & PRESTIGE HIGH AND LOW GLUCOSE CONTROL HOME DIAGNOSTICS, INC. VIK BAJNATH
K963242 11/14/1996 DURACON POSTERIOR FEMORAL SPACER HOWMEDICA CORP. MARGARET F CROWE
K963614 11/06/1996 MONOTUBE CARBON TUBE HOWMEDICA CORP. JOHN DICHIARA
K963485 11/22/1996 SILICONE RUBBER CUFF/DISPOSABLE FLEECE LINER'S WEB TORSO RESRAINT,NYON LIMB HOLDER,VINYL LIMB HOLDER,NYLON BED RESTRAINS HUMANE RESTRAINT, INC. STACY R SCHULTZ
K962450 11/25/1996 HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE HYCOR BIOMEDICAL, INC. MEHDI ALEM
K962452 11/25/1996 HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA HYCOR BIOMEDICAL, INC. MEHDI ALEM
K962341 11/25/1996 HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG) HYCOR BIOMEDICAL, INC. MEHDI ALEM
K962451 11/25/1996 HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO) HYCOR BIOMEDICAL, INC. MEHDI ALEM
K960512 11/21/1996 GEMINI PC-ITX IMED CORP. DALE COLEMAN
K963186 11/12/1996 ORTHO 8000 INNER VISION MRI LTD. DIANA UPTON
K963402 11/04/1996 INNOVASIVE 2.8MM ROC SUTURE BONE FASTENER AND 3.5MM ROC SUTURE BONE FASTENER INNOVASIVE DEVICES, INC. ERIC BANNON
K963598 11/27/1996 INNOVATIVE TECHNOLOGIES ALIGINATE/PECTIN WOUND DRESSINGS INNOVATIVE TECHNOLOGIES LTD. PRISCILLA WHITEHEAD
K955835 11/19/1996 FLUID BARRIER BOOT KNEE & ANKLE-HIGH INSTRUMENT MAKAR, INC. BRENDA J SPARKS
K963800 11/13/1996 IL SYNTHESIS INSTRUMENTATION LABORATORY CO. BETTY J LANE
K955122 11/04/1996 INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD INTERMEDICS, INC. LORI KLEINSCHRODT HOLDER
K963132 11/18/1996 MINI STRIP/SERUM HCG INTERNATIONAL NEWTECH DEVELOPMENT, INC. JESSE ZHU
K963133 11/18/1996 PS-UNIT CASSETTE/SERUM HCG INTERNATIONAL NEWTECH DEVELOPMENT, INC. JESSE ZHU
K963890 11/19/1996 VARIOUS SUNGLASSES (NON-PRESCRIPTION) ITALIAN EYEWEAR, INC. ALESSANDRO RESTIVO
K963442 11/22/1996 JACKETS AND VESTS J. T. POSEY CO. MICHAEL KEEFE
K963414 11/22/1996 MULTIPLE BELTS J. T. POSEY CO. MICHAEL KEEFE
K963413 11/14/1996 MULTIPLE LIMB HOLDERS J. T. POSEY CO. MICHAEL KEEFE
K963439 11/19/1996 PEDIATRIC LIMB HOLDERS J. T. POSEY CO. MICHAEL KEEFE
K963437 11/19/1996 PELVIC HOLDERS J. T. POSEY CO. MICHAEL KEEFE
K963409 11/14/1996 POSEY HUGGER J. T. POSEY CO. MICHAEL KEEFE
K963411 11/19/1996 POSEY LAPTOP TRAYS J. T. POSEY CO. MICHAEL KEEFE
K963410 11/22/1996 POSEY STRAIGHT JACKETS J. T. POSEY CO. MICHAEL KEEFE
K963436 11/22/1996 RESTRAINT ACCESSORIES J. T. POSEY CO. MICHAEL KEEFE
K963891 11/19/1996 "RX 96E" JENERIC/PENTRON, INC. MURRAY G GAMBERG
K964310 11/27/1996 VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010) JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. ANN M QUINN
K964308 11/27/1996 VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025) JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. ANN M QUINN
K963117 11/06/1996 P.F.C. CRUCIATE RETAING KNEE SYSTEM JOHNSON & JOHNSON PROFESSIONALS, INC. JOHN FERROS, SR.
K963809 11/20/1996 COOL-ZONE KAPPLER USA PHILIP C MANN
K963524 11/14/1996 KSEA LARGE JOINT ARTHROSCOPY SET KARL STORZ ENDOSCOPY KEVIN A KENNAN
K961605 11/13/1996 KARL STORZ 10.5 FR. FLEXIBLE HYSTEROSCOPE KARL STORZ ENDOSCOPY-AMERICA, INC. MARIKA ANDERSON
K963426 11/07/1996 KARL STORZ CONTACT MICRO-LARYNGOSCOPES KARL STORZ ENDOSCOPY-AMERICA, INC. MARIKA ANDERSON
K962863 11/19/1996 KARL STORZ MODEL 264305-20 ELECTRONIC ENDOFLATOR KARL STORZ ENDOSCOPY-AMERICA, INC. RENATE M MACLAREN
K955756 11/26/1996 KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR KARL STORZ ENDOSCOPY-AMERICA, INC. RENATE A MACLAREN
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K963371 11/07/1996 BEST STRAP RESTRAINT MORRISON MEDICAL PRODUCTS JOSEPH S TOKARZ
K963370 11/08/1996 CINCH STRAP WITH BUCKLE MORRISON MEDICAL PRODUCTS JOSEPH S TOKARZ
K963387 11/08/1996 DELUXE LIMB RESTRAINT WITH DOUBLE D-RING AND STRAP DELUXE LIMB RESTRAINT WITH STRAP MORRISON MEDICAL PRODUCTS JOSEPH S TOKARZ
K963494 11/06/1996 MORRISON MEDICAL DISPOSABLE RESTRAINT STRAP MORRISON MEDICAL PRODUCTS JOSEPH S TOKARZ
K963399 11/06/1996 MORRISON MEDICAL STRETCHER/COT AND BACKBOARD RESTRAINTS MORRISON MEDICAL PRODUCTS JOSEPH S TOKARZ
K963374 11/08/1996 TORSO/WAIST RESTRAINT MORRISON MEDICAL PRODUCTS JOSEPH S TOKARZ
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K963432 11/13/1996 GUIDE WIRES FOR CANNULATED SCREWS ORTHOPAEDIC BIOSYSTEMS, LTD. JEFFRY B SKIBA
K963433 11/06/1996 THREADED FIXATION PIN ORTHOPAEDIC BIOSYSTEMS, LTD. JEFFRY B SKIBA
K963394 11/14/1996 OSTEOMED TRAM OSTEOMED CORP. JAMES D LAFFERTY
K963788 11/27/1996 PRIMOFOCUS COMPACT OTICON CORP. PREBEN BRUNVED
K951226 11/21/1996 VITALMAX 4000/MINIPACK 3100/3000 PACE TECH, INC. ILHAN M BILGUTAY
K964144 11/27/1996 PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF - PCP-MF PARA SCIENTIFIC CO. ERIC CARLSON
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K963815 11/05/1996 REUSABLE TROCAR WITH SLEEVE (COMMON) PILLING WECK GROUP KARENANN J BROZOWSKI
K962771 11/19/1996 BURKE CONGENITAL THORACOSCOPY INSTRUMENTS PILLING WECK, INC. RICHARD G JONES
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K961588 11/18/1996 TOTAL IRON (NITRO-PAPS) REAGENT SET POINTE SCIENTIFIC, INC. WILLIAM F WALTERS
K963513 11/07/1996 CARDIAC STATUS TROPONIN I PRINCETON BIOMEDITECH CORP. JEMO KANG
K963693 11/29/1996 OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST PRINCETON BIOMEDITECH CORP. JEMO KANG, PH.D.
K962038 11/13/1996 PES HOT/COLD COMPRESS PRINCETON ELECTRONIC SYSTEMS, INC. CHARLES H SEIDEL, JR.
K962623 11/26/1996 OSMOCYTE ULTRA/PE PILLOW WOUND DRESSING PROCYTE CORP. PAUL KETTERIDGE
K960315 11/20/1996 FLAVORED LATEX PATIENT EXAMINATION PT. IRAMA DINAMIKA LATEX ANIL TANEJA
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K963579 11/08/1996 PACE-1A CARDIAC STIMULATOR RADIONICS, INC. AMY J LAFORTE, PH.D
K963577 11/21/1996 RADIONICS SLUIJTER-MEHTA CANNULA RADIONICS, INC. AMY LAFORTE PH.D.
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K962068 11/08/1996 LIGHTSTIC MODEL 180 RARE EARTH MEDICAL, INC. RICHARD G HUNTER
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K964064 11/20/1996 RDI LIPIDIRECT MAGNETIC LDL REAGENT REFERENCE DIAGNOSTICS, INC. JOSEPH LAWLOR, PH.D.
K963912 11/06/1996 TYCO BABY SESAME STREET SOFT TEETHER REGU-TECH ASSOC., INC. ROBERT J STAAB
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K964051 11/05/1996 NEEDLE, ACUPUNCTURE S-TCM ENTERPRISES, INC. GUOJI GONG, M.D.
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K963525 11/07/1996 DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT SHIELD DIAGNOSTICS, LTD. EILEEN MCCAFFERTY
K962825 11/15/1996 SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY SHIELD DIAGNOSTICS, LTD. EILEEN MCCAFFERTY
K963617 11/08/1996 SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-120 SHIMADZU MEDICAL SYSTEMS MICHAEL FISHBACK
K963704 11/26/1996 MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGE SHIPPERT MEDICAL TECHNOLOGIES CORP. SARAH MAXWELL LAKE
K953233 11/29/1996 SIMVIEW 3000 CT OPTION SIEMENS MEDICAL SOLUTIONS USA, INC. KENNETH MICHAEL
K963042 11/01/1996 INNOSAN TRAVELAIR S PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853 SIM ITALIA S.R.L. SUSAN MURATORI
K963025 11/01/1996 SLEEPNET HUMIDIFIER,(84200 PACKAGED) SLEEPNET CORPORATION THOMAS E ASACKER
K963893 11/07/1996 FIBRE INTERSPACED X-RAY GRID SMIT RONTGEN ING. R.W. RIJNTJES
K963901 11/04/1996 ELECTROSURGICAL PROBE SMITH & NEPHEW ENDOSCOPY, INC. ELIZABETH A RYAN
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K963489 11/12/1996 WHEEL CHAIR ACCESSORY SMITH AND NEPHEW DONJOY, INC. DAN W MILLER
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K963995 11/26/1996 STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER STARKEY LABORATORIES, INC. SHARI L SWIDEN
K963838 11/26/1996 STARKEY TM AIR CONDUCTION TINNITUS MASKER STARKEY LABORATORIES, INC. RICK STROMBERG
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K963401 11/05/1996 TPS APICAL IMPLANT STERI-OSS, INC. PAUL GASSER
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K963491 11/14/1996 STUCKEY STRAP-3 FINGER RESTRAINTS STUCKEY ENT., INC. JUDY STUCKEY
K962252 11/25/1996 HEALTH O METER ELECTRIC HEATING PAD W/MASSAGE MODEL EHP4 SUNBEAM HEALTH DIVISION FRANK BRICHETTOR
K962195 11/27/1996 HEALTH O METER ELECTRIC HEATING PADS MODELS EHP2, EHP3 SUNBEAM HEALTH DIVISION FRANK BRICHETTO
K962792 11/12/1996 LINAC SCALPEL TREATMENT PLANNING SYSTEM SURGICAL NAVIGATION TECHNOLOGIES, INC. KURT R SMITH
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K963618 11/12/1996 SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF) SYNTHES (USA) ANGELA J SILVESTRI
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K963172 11/08/1996 SYNTHES STERILE 4.5 MM CANNULATED SCREWS SYNTHES (USA) ANGELA J SILVESTRI
K962913 11/14/1996 SYNTHES STERILE DRILL BITS SYNTHES (USA) ANGELA J SILVESTRI
K963798 11/27/1996 SYNTHES TITANIUM ALLOY VOLAR DISTAL RADIUS PLATE (TI ALLOY VDRP) SYSTEM SYNTHES (USA) ANGELA SILVESTRI
K963135 11/29/1996 GIARDIA CELISA TECHLAB, INC. DAVID M LYERLY, PH.D.
K963554 11/21/1996 24448-010 SECURE-ALL FINGER CONTROL MITT TECNOL MEDICAL PRODUCTS, INC. RUTH L JONES
K963773 11/21/1996 24457-010 SECURE ALL PELVIC HOLDER/24458-010 SECURE ALL BODY BELT TECNOL MEDICAL PRODUCTS, INC. RUTH L JONES
K963564 11/22/1996 PERSONAL LIMB HOLDER (24444-200,300,24444-KIT) TECNOL MEDICAL PRODUCTS, INC. RUTH L JONES
K963552 11/22/1996 QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350) TECNOL MEDICAL PRODUCTS, INC. RUTH L JONES
K963556 11/21/1996 SECURE-ALL 1-PIECE BODY HOLDER, SMALL/MEDIUM (24451-010,020,24452-010,020,030) TECNOL MEDICAL PRODUCTS, INC. RUTH L JONES
K963557 11/21/1996 SYSTEM 2 ZIPPERED BODY HOLDER, SMALL/MEDIUM 24453-010,24453-020,24453-030 TECNOL MEDICAL PRODUCTS, INC. RUTH L JONES
K963561 11/21/1996 ULTRA CARE VEST STYLE BODY HOLDER, SMALL (24455-010,020,030,040,24456-010,020,030,040) TECNOL MEDICAL PRODUCTS, INC. RUTH L JONES
K963563 11/21/1996 ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL(24454-010,020,030,040,015,025,035,045,115,125,135,145) TECNOL MEDICAL PRODUCTS, INC. RUTH L JONES
K963559 11/22/1996 WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010) TECNOL MEDICAL PRODUCTS, INC. RUTH L JONES
K962019 11/25/1996 C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST TECO DIAGNOSTICS K.C. CHEN
K962015 11/25/1996 RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST TECO DIAGNOSTICS K.C. CHEN, PH.D.
K963915 11/08/1996 TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION TELEX COMMUNICATIONS, INC. TOM SCHELLER
K963686 11/25/1996 ANSPACH SUTURE ANCHOR (MODIFIED) THE ANSPACH EFFORT, INC. WILLIAM E ANSPACH, III
K960630 11/19/1996 ANSPAHC SPEED REDUCER THE ANSPACH EFFORT, INC. WILLIAM E ANSPACH
K954679 11/08/1996 THERAPLAN PLUS THERATRONICS, INC. E. S MARTELL
K963247 11/07/1996 VICTOR MODEL OCPR OXYGEN CONSERVING PRESSURE REGULATOR THERMADYNE HOLINGS CORP. ROBERT C SHERWIN, PE
K964349 11/27/1996 AIA-PACK FOLATE ASSAY TOSOH MEDICS, INC. LORI ROBINSON
K963687 11/08/1996 AIA-PACK FT3 ASSAY TOSOH MEDICS, INC. LORI ROBINSON
K963193 11/13/1996 ACCU-BEAM LASER BLOCK 301513BG385/BEAM SPLITTERS 301513BG39 TRANSAMERICAN TECHNOLOGIES INTL. ALLEN R HOWES
K964266 11/12/1996 BIAD NUCLEAR IMAGING SYSTEM TRIONIX RESEARCH LABORATORY, INC. DAPHNE REED
K964265 11/12/1996 CARDIAC TRIAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM TRIONIX RESEARCH LABORATORY, INC. DAPHNE REED
K964267 11/12/1996 MONAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM TRIONIX RESEARCH LABORATORY, INC. DAPHNE REED
K962481 11/27/1996 QUASAR RECOVERY IMAGING PACKAGE TRIONIX RESEARCH LABORATORY, INC. CHUN B LIM, PH.D.
K964268 11/12/1996 TRIAD 88 NUCLEAR IMAGING SYSTEM TRIONIX RESEARCH LABORATORY, INC. DAPHNE REED
K963999 11/27/1996 AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC CHRISTOPHER TAYLOR
K964508 11/27/1996 UNITRON MODEL ICON AOHP +4 (ICON AOHP +4) UNITRON INDUSTRIES, INC. JERRY G JOHNSON
K964510 11/27/1996 UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4) UNITRON INDUSTRIES, INC. JERRY G JOHNSON
K964504 11/27/1996 UNITRON MODEL ICON AOHPL +4 UNITRON INDUSTRIES, INC. JERRY G JOHNSON
K964503 11/27/1996 UNITRON MODEL SOUND F/X +4 UNITRON INDUSTRIES, INC. JERRY G JOHNSON
K964511 11/27/1996 UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +4) UNITRON INDUSTRIES, INC. JERRY G JOHNSON
K964502 11/27/1996 UNITRON MODEL SOUND F/XP +4 UNITRON INDUSTRIES, INC. JERRY G JOHNSON
K962180 11/07/1996 CATH SEAL UNIVERSAL MEDICAL INSTRUMENT CORP. RICHARD LINKERT
K962389 11/21/1996 EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE UNOMEDICAL SDN BHD PATRICK J LAMB
K963210 11/13/1996 VAIL 100 PEDIATRIC CRIB VAIL PRODUCTS, INC. NANCY VAIL
K962690 11/04/1996 E2590 - B, ARGON ACCESSORY WITH BLADE ELECTRODE AND E2590 - N, ARGON ACCESSORY WITH NEEDLE ELECTRODE VALLEYLAB, INC. PEGGY WALLINE
K963611 11/21/1996 VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH VASCUTEK LTD. TEENA M AUGOSTINO
K963298 11/06/1996 FIRST AID KIT(S) VECTOR, INC. JON HEAVEY
K963415 11/25/1996 VENTREX OXYGEN SENSOR VENTREX, LLC. MARY HUEGEL
K963344 11/21/1996 DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE VISION-SCIENCES, INC. PAMELA PAPINEAU
K953591 11/29/1996 CEP 8 SPECTRUMORANGE DNA PROBE KIT VYSIS RUSSELL K ENNS
K964588 11/29/1996 WATERS 515 HPLC PUMP (515) WATERS CORPORATION VIRGINIA L CORBIN
K961797 11/06/1996 WLP GRADIENT SEQUENTIAL VERSION/WLP PROLITE/WLP WLP-II LITE WRIGHT LINEAR PUMP, INC. JOE SORIERO
K961292 11/06/1996 WLP SEQUENTIAL VERSION MODEL WLP SOLO VI, WLP SOLO SEQUENTIAL WRIGHT LINEAR PUMP, INC. JOE SORIERO
K961891 11/06/1996 WLP SINGLE-SEGMENT VERSION WLP SOLO VII WRIGHT LINEAR PUMP, INC. JOE SORIERO
K963905 11/12/1996 RADIOGRAPHIC ITT TABLE X-RAY TECHNOLOGIES, INC. RANDY DUFFY
K962593 11/12/1996 ELECTROSURGICAL PROBES & DEVICES XIMED/PROSURE/INJECTX ASHVIN DESAI
K963609 11/14/1996 PHASE PLUS ZHERMACK S.P.A. EVAN DICK
K963435 11/06/1996 ECONOMY SAFETY VEST RESTRAINT, SHOULDER TIE SAFETY VEST/SAFETY VEST RESTRAINT, HEAVY DUTY VEST RESTRAINT, MESH SAFETY VE ZIMMER PATIENT CARE DIVISION PAUL OSORIO
K963431 11/06/1996 POLYESTER PIL WRIST/ANKLE RESTRAINT/WRIST RESTRAINT UNIVERSAL/SOFT FLANNEL WRIST/ANKLE RESTRAINT/FOAM LIMB HOLDER ZIMMER, INC. PAULA OSORIO
K964286 11/19/1996 ZOMED PASSIVE TEMPERATURE PROBE ZOMED INTL. THOMAS C WEHMAN, PH.D.


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