FDA 510(k) Applications Received During November, 1976

FDA 510(k) Number Submission Date Device Name Applicant Contact
K761153 11/29/1976 GLUC OPAP, IN VITRO DIAG. FOR GLUCOSE ADVANCED BIOMEDICAL METHODS, INC.
K761154 11/29/1976 GLUCOSE OXIDASE REAG FOR BECKMAN ANALYZ ADVANCED BIOMEDICAL METHODS, INC.
K761152 11/29/1976 S-UREA-N, IN VITRO DIAG FOR BUN ADVANCED BIOMEDICAL METHODS, INC.
K761080 11/19/1976 ISOLATION GOWN PACK AMERICAN HOSPITAL SUPPLY CORP.
K760959 11/01/1976 SURGICAL CHISEL AMERICAN SAFETY EQUIPMENT CORP.
K760956 11/01/1976 SURGICAL MICRO DRILL AMERICAN SAFETY EQUIPMENT CORP.
K760958 11/01/1976 SURGICAL OSCILLATING SAW AMERICAN SAFETY EQUIPMENT CORP.
K760957 11/01/1976 SURGICAL RECIPROCATING SAW AMERICAN SAFETY EQUIPMENT CORP.
K760960 11/01/1976 SURGICAL WIRE DRIVER AMERICAN SAFETY EQUIPMENT CORP.
K761004 11/08/1976 X-RAY SCANNER, WHOLE BODY, AS&E AMERICAN SCIENCE AND ENGINEERING, INC.
K761100 11/23/1976 MULTI-CELL ULTRAFILTRATION SYSTEM AMICON, INC.
K761018 11/10/1976 SURGICAL LIGHT - CHALLENGE 22 SERIES AMSCO CO.
K760963 11/04/1976 DECUBITUS MATTRESS ARCO MEDICAL PRODUCTS CO.
K761162 11/30/1976 BRACHIAL PLEXUS BLOCK ANESTHESIA KIT ARROW INTL., INC.
K761098 11/22/1976 FILTER DEVICES ARROW INTL., INC.
K760942 11/01/1976 GENTASAK BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K761061 11/18/1976 BLOOD-UREA-NITROGEN (BUN) ANALYZER 2 BECKMAN INSTRUMENTS, INC.
K760939 11/01/1976 CORTISOL REAGENT SYSTEM BECKMAN INSTRUMENTS, INC.
K761060 11/18/1976 GLUCOSE ANALYZER 2 BECKMAN INSTRUMENTS, INC.
K761136 11/24/1976 GLUCOSE ANALYZER 2 W/ CHOLES. REAG KT BECKMAN INSTRUMENTS, INC.
K761089 11/22/1976 GLUCOSE ANALYZER W/ CHOLESTEROL REAG KIT BECKMAN INSTRUMENTS, INC.
K761149 11/26/1976 MODEL 203 DISPENSER BECKMAN INSTRUMENTS, INC.
K761019 11/11/1976 PIPETTER-DILUTER (MODEL 273) BECKMAN INSTRUMENTS, INC.
K761058 11/18/1976 QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT BIO/DATA CORP.
K761091 11/22/1976 TPC-LYOPHILIZED POOLED HUMAN PLASMA BIO/DATA CORP.
K761023 11/11/1976 SIMULATOR, 10 LEAD ECG BIRTCHER CORP.
K760971 11/04/1976 POSITIVE DISPLACEMENT SPIROMETER BOEHRINGER LABORATORIES
K761148 11/26/1976 REFLOMAT/REFLOTEST SYSTEM BOEHRINGER MANNHEIM CORP.
K761083 11/19/1976 BARD URINE METER W/ BAG C.R. BARD, INC.
K760997 11/08/1976 UNDER BOTTOCKS DRAPE C.R. BARD, INC.
K761011 11/09/1976 CASTLE TEC-TEST AERATION MONITOR CASTLE CO.
K761015 11/09/1976 MARKET CASTLE UNISPHERE CASTLE CO.
K761037 11/15/1976 INTERSORB LAPAROTOMY SPONGE CHESEBROUGH-POND'S U.S.A. CO.
K761161 11/29/1976 67-8006 DARLING-LINTON AORTIC TOURN. CODMAN & SHURTLEFF, INC.
K761002 11/08/1976 CHARNLEY CONGENITAL HIP FEMUR (85-3060) CODMAN & SHURTLEFF, INC.
K761003 11/08/1976 CHARNLEY CONGENITAL HIP FEMUR (85-3061) CODMAN & SHURTLEFF, INC.
K760974 11/03/1976 CHARNLEY FEMORAL COMPONENT CODMAN & SHURTLEFF, INC.
K760977 11/03/1976 CHARNLEY FEMUR DRILL #1 AND #2 CODMAN & SHURTLEFF, INC.
K760976 11/03/1976 CHARNLEY REVISION SET CODMAN & SHURTLEFF, INC.
K761097 11/22/1976 VANDERBILT BLADE HOLDER CODMAN & SHURTLEFF, INC.
K761095 11/22/1976 VANDERBILT CURETTE CODMAN & SHURTLEFF, INC.
K761096 11/22/1976 VANDERBILT PITUITARY RETRACTOR CODMAN & SHURTLEFF, INC.
K761034 11/15/1976 SURGEX SURGICAL SPONGE CONVERTORS
K761014 11/09/1976 CARDIART 108T/313 CONWAY ELECTRONIC ENTERPRISES LTD.
K761007 11/08/1976 ARTIFICIAL KIDNEY, C-DAK CORDIS DOW CORDIS CORP.
K761160 11/29/1976 MODEL CNA-1 VAPORIZER CYPRANE NORTH AMERICA, INC.
K761013 11/09/1976 SPINETTE CENTRIFUGE DAMON CORP.
K761017 11/10/1976 PRESSURE MODULE (MODEL P3) DATASCOPE CORP.
K761065 11/18/1976 NEONATAL RESUSCITATOR, SAMSON DEM MEDICAL, INC.
K761064 11/18/1976 COVENTRY STAPLE DEPUY, INC.
K761088 11/22/1976 DEPUY MODIFIED SKELETAL TRACTION PIN DEPUY, INC.
K761101 11/23/1976 NEY VIBRATOR DERINGER-NEY INC.
K761102 11/23/1976 NEY-LITE DERINGER-NEY INC.
K761094 11/23/1976 UVA PHOTOTHERAPY SYSTEM DERMATRON CORP.
K760951 11/01/1976 DEVON COOL FACE DEVON INDUSTRIES, INC.
K760950 11/01/1976 DEVON KNEE STRAP DEVON INDUSTRIES, INC.
K761157 11/29/1976 AMINOGLYCOSIDE (125I) RIA KIT DIAGNOSTIC PRODUCTS CORP.
K760967 11/04/1976 TOBRAMYCIN RIA KIT DIAGNOSTIC PRODUCTS CORP.
K760943 11/01/1976 SILASTIC BRAND GASTRIC LAVAGE TUBE DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
K760945 11/01/1976 SILASTIC PERCUTANEOUS GASTROINTEST. TUBE DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
K760995 11/08/1976 DECOLLATING TRAY DRAVON MEDICAL, INC.
K760994 11/08/1976 MONITOR LINE W/FILTER & NEEDLE DRAVON MEDICAL, INC.
K760952 11/02/1976 TERASAKI LYMPHOCYTE TRANSPORT KIT DRAVON MEDICAL, INC.
K761051 11/15/1976 BI-FLOW NEEDLE DWS, INC.
K761050 11/15/1976 HEPARIN PUMP DWS, INC.
K761076 11/19/1976 DEMODULATOR/CARDIOTACHOMETER ELDECO
K761074 11/19/1976 DYNAMIC RECORDER (DR-10) ELDECO
K761073 11/19/1976 POCKET TRANSMITTER (PT-10) ELDECO
K761075 11/19/1976 SPORTS RECORDER (SR-10) ELDECO
K761077 11/19/1976 TREND ANALYZER ELDECO
K761031 11/15/1976 ELECATH ARTERIAL EMBOLECTOMY CATHETER ELECTRO-CATHETER CORP.
K761049 11/15/1976 KENATRON EPILATOR EPILATOR CORP.
K761147 11/26/1976 RELIANCE MOD-U-LINE M-700 F. & F. KOENIGKRAMER
K761227 11/09/1976 INTERMITTENT PRESSURE PAD FLOWTRON-AIRE LTD.
K761140 11/26/1976 FRASER SWEATMAN'S DOUBLE MASK FRASER SWEATMAN, INC.
K761104 11/19/1976 ADULT SWIVEL FORK FRED SAMMONS, INC.
K761133 11/19/1976 AESTHESIOMETER FRED SAMMONS, INC.
K761130 11/19/1976 BATHTUB RAILS FRED SAMMONS, INC.
K761110 11/19/1976 BED TRAY FRED SAMMONS, INC.
K761116 11/19/1976 BREATH CONTROL GAME FRED SAMMONS, INC.
K761113 11/19/1976 BUILT-UP HANDLE UTENSILS FRED SAMMONS, INC.
K761129 11/19/1976 CONTOURED RAISED TOILET SEAT FRED SAMMONS, INC.
K761123 11/19/1976 ELECTRIC RAZOR HOLDER FRED SAMMONS, INC.
K761121 11/19/1976 ELECTRIC VIBRATOR FRED SAMMONS, INC.
K761126 11/19/1976 EXTRA LARGE LONG HANDLED SPONGE FRED SAMMONS, INC.
K761114 11/19/1976 FOAM SLIPPERS FRED SAMMONS, INC.
K761107 11/19/1976 FOOD GUARDS FRED SAMMONS, INC.
K761118 11/19/1976 HAND SCREW CLAMP FRED SAMMONS, INC.
K761117 11/19/1976 KEYBOARD SHEILDS FRED SAMMONS, INC.
K761128 11/19/1976 LATERAL TRUNK SUPPORTS FRED SAMMONS, INC.
K761127 11/19/1976 LONG HANDLED BATH BRUSH FRED SAMMONS, INC.
K761125 11/19/1976 LONG HANDLED SPONGE FRED SAMMONS, INC.
K761108 11/19/1976 PLASTIC DISPOSABLE BIB FRED SAMMONS, INC.
K761134 11/19/1976 PLASTIC FINGER CUFFS FRED SAMMONS, INC.
K761112 11/19/1976 PLASTIC HAND CONE FRED SAMMONS, INC.
K761122 11/19/1976 PRUNING SCISSORS FRED SAMMONS, INC.
K761115 11/19/1976 ROLLING PIN FRED SAMMONS, INC.
K761131 11/19/1976 SAFETY PIN SPLINT FRED SAMMONS, INC.
K761119 11/19/1976 SHEET METAL CLAMP FRED SAMMONS, INC.
K761135 11/19/1976 SHORT INFLATED ROLLS FRED SAMMONS, INC.
K761120 11/19/1976 SPIN-A-PULL FRED SAMMONS, INC.
K761111 11/19/1976 SQUARE FOOD GUARD FRED SAMMONS, INC.
K761109 11/19/1976 TERRYCLOTH BIBS FRED SAMMONS, INC.
K761132 11/19/1976 TUNING FORK FRED SAMMONS, INC.
K761124 11/19/1976 WEED PULLER & PRUNER FRED SAMMONS, INC.
K761106 11/19/1976 WEIGHTED FORK FRED SAMMONS, INC.
K761105 11/19/1976 WEIGHTED SPORK FRED SAMMONS, INC.
K761145 11/26/1976 RADIOISOTOPE CALIBRATOR (CRCO-22NB) G.D. SEARLE AND CO.
K761139 11/26/1976 T-M (TIME-MOTION) OPTION G.D. SEARLE AND CO.
K760935 11/01/1976 WINGED FISTULA NEEDLE GAMBRO, INC.
K760941 11/01/1976 MASK ARTIFICIAL RESPIRATION GENE R. BALDWIN
K761159 11/29/1976 PORTACAMERA 11-B GENERAL ELECTRIC CO.
K761087 11/22/1976 ELECTRONIC CONTROL UNIT GORMAN RUPP INDUSTRIES
K760954 11/02/1976 CROWNTEX EXAM. CAPE & GOWN GRAHAM MANUFACTURING CO.
K761028 11/12/1976 AUTO-ALBUMIN REAG FOR ABBOTT ABA-100 HARLECO
K761029 11/12/1976 AUTO-CALCIUM REAG FOR GILFORD 3400E ANAL HARLECO
K761027 11/12/1976 AUTO-TOTAL BILIRUBIN REAG FOR GILFORD AN HARLECO
K761026 11/12/1976 AUTO-ALBUMIN REAG FOR GILFORD 3400E ANAL HARLECO DIAGNOSTICS
K761055 11/15/1976 CALCULATOR PLOTTER (MODEL 9872A) HEWLETT-PACKARD CO.
K760968 11/04/1976 CENTRAL STATION REPEATER (MODEL 8032A) HEWLETT-PACKARD CO.
K761056 11/15/1976 DISPLAY MONITOR (MODEL 78301A) HEWLETT-PACKARD CO.
K760999 11/08/1976 THERMOGRAPH, MEDICAL HONEYWELL, INC.
K761008 11/02/1976 LYMPHOCYTE TYPING, NEGATIVE CONTROL HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K761009 11/02/1976 LYMPHOCYTE TYPING, POSITIVE CONTROL HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K760969 11/04/1976 PH/BLOOD GAS SYSTEM INSTRUMENTATION LABORATORY CO.
K760975 11/03/1976 WEIL ONCOMETER (IL 186) INSTRUMENTATION LABORATORY CO.
K761059 11/18/1976 MALE URINARY CATHETER, EXTERNAL INTERMED, INC.
K761000 11/08/1976 PAP-TRAY I (CATALOG #C600-1) LERNER LABORATORIES, INC.
K761001 11/08/1976 PAP-TRAY II (CATALOG #C600-2) LERNER LABORATORIES, INC.
K761144 11/26/1976 FEM CATH (URETHRAL CATHETER) MALLINCKRODT CRITICAL CARE
K760998 11/08/1976 ENDOTRACHAEL TUBE AND HOLDER MCGAW RESPIRATORY THERAPY
K761078 11/19/1976 HEMO-CATH I, KIDNEY DIALYSIS CATHETER MEDICAL DISPOSABLES INTL., INC.
K761092 11/22/1976 INGUINAL COMPRESSIVE DEVICE (ICD) MEDICAL ELECTRONIC DEVICES, INC.
K761032 11/15/1976 CRADLING SYSTEM MEDIN CORP.
K761020 11/11/1976 ANKLE (FREEMAN-SWANSON) MEDISHIELD, INC.
K761021 11/11/1976 ANKLE INSTRUMENTS (FREEMAN-SWANSON) MEDISHIELD, INC.
K760944 11/01/1976 ANGIOGRAPHIC GUIDEWIRE MEDRAD, INC.
K761063 11/18/1976 GAMMACORD II CALCULATOR INTERFACE MILES LABORATORIES, INC.
K761062 11/18/1976 HISTO-TEK W/ AUTOMATIC COVERSLIPPER MILES LABORATORIES, INC.
K761012 11/09/1976 ALPHABED ALTERNATING PRESSURE PAD NLOWTRON-AIRE LTD.
K761137 11/24/1976 MICROSAMPLE BLOOD COLLECTION DEVICE ORTHO DIAGNOSTICS, INC.
K761150 11/26/1976 GALLENAUGH BONE PLATES ORTHOPEDIC EQUIPMENT CO., INC.
K761146 11/26/1976 SPARBARO TYPE TOTAL HIP ORTHOPEDIC EQUIPMENT CO., INC.
K761036 11/15/1976 WILSON SPINAL FRAME ORTHOPEDIC EQUIPMENT CO., INC.
K761143 11/26/1976 LITHIUM IODIDE BATTERY PACEMAKER (#201) PACESETTER SYSTEMS
K761093 11/22/1976 BANDAGE PACO PHARMACEUTICAL SERVICES, INC.
K761035 11/15/1976 SURGICAL BLADE HANDLES PARKE-DAVIS CO.
K760955 11/02/1976 PHADEBAS T4 RIA PHARMACIA, INC.
K761158 11/29/1976 FLUID DISPENSING SYSTEM PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K761039 11/15/1976 URINARY LEG BAG DRAINAGE TUBE PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K761066 11/18/1976 ECG MONITOR (TELEPHONE ECG TRANSMITTER) PHYSIO-CONTROL CORP.
K761040 11/15/1976 POWERED TREADMILL (20/ST) PHYSIO-CONTROL CORP.
K761041 11/15/1976 POWERED TREADMILL (30/ST) PHYSIO-CONTROL CORP.
K761141 11/26/1976 ARTERIAL GRAFT SIZERS PILLING CO.
K761079 11/19/1976 FLEXIBLE TIP ASPIRATING TUBES PILLING CO.
K761142 11/26/1976 HEADLIGHTS W/ FILTER-OPTICO CABLES PILLING CO.
K760934 11/01/1976 HOSPITALITY SERVER PLASTICS/PACKAGING
K761067 11/18/1976 DENTSPLY DIE STONE RANSOM AND RANDOLPH
K760964 11/04/1976 ADDI-MIST RESPIRATORY CARE, INC.
K761053 11/15/1976 ANODYNE II-ELECTRICAL NEURO STIMULATOR RICH-MAR CORP.
K760949 11/01/1976 CHARLES IRRIGATING FUNDUS CONTACT LENS RICHARD'S MEDICAL EQUIP., INC.
K760970 11/04/1976 FLORIO CPC BAND RICHARD'S MEDICAL EQUIP., INC.
K761025 11/12/1976 BAG RESUSCITATOR ROBERT SHAW CONTROLS CO.
K761057 11/18/1976 ARTERIOSONDE BLOOD PRESS. MNTR. (#1020) ROCHE MEDICAL ELECTRONICS, INC.
K760973 11/03/1976 HEMODIALYSIS CANNULA & FEMORAL CLAMP RODELL MEDICAL, INC.
K760946 11/01/1976 B12/FOLATE SING. TUBE DUAL RADIOASSAY KT SCHWARZ MANN
K760965 11/04/1976 BEDSIDE CONSOLES (11-3-910 & 11-3-930) SEATTLE ARTIFICIAL KIDNEY SUPPLY CO.
K760966 11/04/1976 CATHETER, UMBILICAL ARTERY SHERWOOD MEDICAL INDUSTRIES
K761086 11/15/1976 REAGENTS SIMMLER & SON, INC.
K761030 11/12/1976 EKOSECTOR I SMITH KLINE DIAGNOSTICS, INC.
K761052 11/15/1976 REAL TIME OBSTETRICAL ULTRASONIC SCANNER SMITH KLINE DIAGNOSTICS, INC.
K761038 11/15/1976 SINGLE NEEDLE HEMODIALYSIS SORENSEN RESEARCH
K761082 11/19/1976 SINGLE NEEDLE HEMODIALYSIS (BFC-142) SORENSEN RESEARCH
K761081 11/19/1976 SINGLE NEEDLE HEMODIALYSIS (BFC-161) SORENSEN RESEARCH
K760953 11/02/1976 DEEP FREEZE SYSTEM (DFS-30) SPEMBLY MEDICAL LTD.
K761156 11/29/1976 AMINOGLYCOSIDE CONTROLS SUPELCO, INC.
K760937 11/01/1976 BARRIER NEURO SHEET SURGIKOS, INC.
K760991 11/05/1976 SURGINE FACE MASK SURGIKOS, INC.
K761033 11/15/1976 COMPUTERIZED TOMOGRAPHY SCANNER SYNTEX CORP.
K760936 11/01/1976 EMIT AMPHETAMINE CONFIRMATION REAGENT SYVA CO.
K760972 11/04/1976 TYCOS DIAGNOSTIC PENLIGHT TAYLOR INSTRUMENT ANALYTICS CO.
K761090 11/22/1976 DIAGNOSTIC METHOD-8-GLUTAMYLTRANSFERASE TECHNICON INSTRUMENTS CORP.
K760948 11/01/1976 THERMO FINER CORETEMP TERUMO AMERICA, INC.
K760947 11/01/1976 PREGELLED DISPOSABLE ELECTRODE TEXAS INSTRUMENTS, INC.
K761069 11/16/1976 P.S.M. BOTIQUE CAP THE OWENBY CO.
K761068 11/16/1976 P.S.M. BOUFFANT CAP THE OWENBY CO.
K761072 11/16/1976 P.S.M. JUSTA COVER THE OWENBY CO.
K761071 11/16/1976 P.S.M. JUSTA KAP THE OWENBY CO.
K761070 11/16/1976 P.S.M. SURGICAL HOOD THE OWENBY CO.
K760993 11/05/1976 MECK/MILLER VENTILATION TUBE HARNESS TIMETER INSTRUMENT CORP.
K760938 11/01/1976 DISPOSABLE HUMIDIFIER TRAVENOL LABORATORIES, S.A.
K761151 11/29/1976 INFUSION PUMP TRAVENOL LABORATORIES, S.A.
K760996 11/08/1976 HEARING AID (MODEL 695D, 905 & 960P) UNITRON INDUSTRIES, INC.
K761103 11/18/1976 WIDEX HEARING AID MODEL F7H & F7T WIDEX HEARING AID CO., INC.
K761099 11/22/1976 DOVER HYPERALIMENTATION DRESSING CHNG KT WILL ROSS CO.
K761155 11/29/1976 CELLULOSE EYE STICK WINN HIRSCH & ASSOC.
K760990 11/05/1976 INORGANIC PHOSPHOROUS REAGENT WORTHINGTON BIOCHEMICAL CORP.
K760989 11/05/1976 URIC ACID REAGENT SET WORTHINGTON BIOCHEMICAL CORP.
K761022 11/11/1976 XERORADIOGRAPHY 125 SYSTEM - MODIFIED XERORADIOGRAPHY
K761138 11/26/1976 FA TISSUE FIXATIVE & WASH SET ZEUS SCIENTIFIC, INC.


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