FDA 510(k) Applications Received During November, 1977

FDA 510(k) Number Submission Date Device Name Applicant Contact
K772137 11/14/1977 VEIN CLAMPS A&A ENT.
K772094 11/07/1977 LIFECARE I.V. PUMP - MODEL III ABBOTT LABORATORIES
K772193 11/28/1977 NASSAL PRESSURE/FLOW RECORDER ADCO LABS.
K772200 11/29/1977 YASARGIL ANEURYSM CLIPS AESCULAP INSTRUMENTS CORP.
K772173 11/21/1977 STETHOSCOPE, ELECTRONIC AFFILIATED MAILORDER CO. SALES, INC.
K772119 11/02/1977 TIME WATCH AKZONA, INC.
K772153 11/15/1977 FLAME PHOTOMETER STANDARD ALKO SCIENTIFIC CO.
K772135 11/14/1977 BIOLOGICAL/CHEMICAL INDICATOR AMSCO CO.
K772122 11/10/1977 T3 RIA KIT ANTIBODIES INC.
K772141 11/14/1977 AEROSOL & OXYGEN MASKS B & F MEDICAL PRODUCTS, INC.
K772169 11/18/1977 AUDIOMETER, RECORDING, AUTOMATIC B&K INSTRUMENTS, INC.
K772098 11/07/1977 DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K772082 11/03/1977 ENZAC URIC ACID 100-TEST KIT BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K772152 11/15/1977 CENTRAL MONITORING SYSTEM BURDICK CORP.
K772150 11/14/1977 DIALYSIS DRAINAGE UNIT, PERITONEAL C.R. BARD, INC.
K772087 11/03/1977 ULTRASONIC DENTURE CLEANER CLAIROL, INC.
K772110 11/07/1977 IN VITRO DIGOXIN RIA TEST CLINICAL ASSAYS, INC.
K772109 11/07/1977 IN VITRO HUMAN TSH RIA TEST CLINICAL ASSAYS, INC.
K772111 11/07/1977 IN VITRO PHENOBARBITAL RIA TEST CLINICAL ASSAYS, INC.
K772108 11/07/1977 IN VITRO T3 RIA TEST CLINICAL ASSAYS, INC.
K772063 11/02/1977 CATHETER, INTRACRANIAL PRESS. MONITOR. CORDIS CORP.
K772194 11/28/1977 IMMO PHASE FT4 ASSAY CORNING MEDICAL & SCIENTIFIC
K772112 11/07/1977 NON-FERMENTER SYSTEM CORNING MEDICAL & SCIENTIFIC
K772183 11/25/1977 THYROID BINDING GLOBULIN CORNING MEDICAL & SCIENTIFIC
K772197 11/25/1977 PACEMAKER, PERM. & TEMP., ELECTRODE DAIG CORP.
K772081 11/03/1977 NAIL, INTRAMEDULLARY, FLEXIBLE DEPUY, INC.
K772120 11/09/1977 TOTAL HIP, CHARNELY TYPE DEPUY, INC.
K772129 11/11/1977 MEDI-JECTOR DERATA CORP.
K772188 11/25/1977 FSH RIA KIT (125I) DIAGNOSTIC PRODUCTS CORP.
K772192 11/25/1977 NEONATAL TSH RIA KIT (125I) DIAGNOSTIC PRODUCTS CORP.
K772191 11/25/1977 TESTOSTERONE RIA KIT (125I) DIAGNOSTIC PRODUCTS CORP.
K772130 11/11/1977 OCULAR CEREBRAL VASCULAR MONITOR DIGILAB, INC.
K772092 11/07/1977 CHEST FLUID MONITOR DYNATECH RESEARCH & DEVELOPMENT CO.
K772093 11/07/1977 IMPEDANCE RHEOGRAPH DYNATECH RESEARCH & DEVELOPMENT CO.
K772143 11/15/1977 GENERATOR ELECTRIC FIELD TECHNOLOGY CORP.
K772125 11/11/1977 TOMOGRAPHIC SCANNER, COMPUTERIZED EMI MEDICAL, INC.
K772151 11/15/1977 URINARY VMA - SCREEN TEST KIT EPPENDORF-BRINKMANN, INC.
K772163 11/16/1977 DIALYSIS MACHINES DM-346 & 346-1 EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K772080 11/03/1977 RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT GELMAN INSTRUMENT CO.
K772073 11/03/1977 RADIAL IMMUNODIFFUSION KIT-COMP. 3 GELMAN INSTRUMENT CO.
K772075 11/03/1977 RADIAL IMMUNODIFFUSION KIT-COMPLEMENT GELMAN INSTRUMENT CO.
K772078 11/03/1977 RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBIN GELMAN INSTRUMENT CO.
K772076 11/03/1977 RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB. GELMAN INSTRUMENT CO.
K772077 11/03/1977 RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.G GELMAN INSTRUMENT CO.
K772079 11/03/1977 RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.M GELMAN INSTRUMENT CO.
K772074 11/03/1977 RADIAL IMMUNODIFFUSION KIT-TRANSFERRIN GELMAN INSTRUMENT CO.
K772106 11/07/1977 PH CALIBRATION BUFFERS GENERAL DIAGNOSTICS
K772184 11/25/1977 X-RAY SYSTEM FOR DENTAL APPLICATION GENERAL ELECTRIC CO.
K772089 11/04/1977 LAPAROTOMY SPOGNE GENERAL MEDICAL CO.
K772139 11/14/1977 RE-CELL SLIDE RECAP GEOMETRIC DATA, DIV. SMITHKLINE CORP.
K772232 11/29/1977 LIQUID NITROGEN SPRAY UNIT GILMORE LIQUID AIR CO.
K772107 11/07/1977 CREATININE URINE APPLI.-#32308 HARLECO
K772157 11/16/1977 CREATININE, 64972 HARLECO
K772156 11/16/1977 ULTRACHEM PHOSPHORUS, 64973 HARLECO
K772155 11/16/1977 ULTRACHEM TOTAL PROTEIN, #64974 HARLECO
K772161 11/16/1977 HEMODIALYSIS APPARATUS HEALD MANUFACTURING, INC.
K772132 11/14/1977 AMPLIFIER MODULE, 78211A ECG HEWLETT-PACKARD CO.
K772102 11/07/1977 AMPLIFIER OTRONA, MODEL N3A-EMG HONEYWELL, INC.
K772140 11/14/1977 SCANNING SYS., AUTO. COMP., ACS1000 HONEYWELL, INC.
K772084 11/04/1977 LAS-R HUMAN C3 PROACTIVATOR TEST HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K772085 11/04/1977 LAS-R HUMAN PLASMINOGEN TEST HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K772114 11/07/1977 FIAX C4 ASSAY IDT, A DIVISION OF WHITTAKER M.A. BIOPRODUCTS
K772072 11/01/1977 MANIFOLD & NEBU. FOR DOUB. LINE MACH. INSPIRON CORP.
K772071 11/01/1977 MANIFOLD & NEBU. FOR SINGLE LINE MACH. INSPIRON CORP.
K772068 11/01/1977 MANIFOLD & NEBULIZER, UNIVERSAL INSPIRON CORP.
K772070 11/01/1977 VENTILATOR SETUP, VOLUME INSPIRON CORP.
K772069 11/01/1977 VOL. VENTILATOR SETUP W/OUT NEBULIZER INSPIRON CORP.
K772199 11/30/1977 CAUTERIES, HOT WIRE, DISP. INTERMEDICS, INC.
K772186 11/25/1977 ELECTROCARDIOGRAPH TRANSMITTER, 536 INTERMEDICS, INC.
K772172 11/21/1977 DYNAZYME TM II CARDIAK-MB J.T. BAKER CHEMICAL CO.
K772154 11/14/1977 CERVICAL TRACTION DIV., PNEUMATIC JOBST
K772128 11/11/1977 FLUORESCEIN CONJUGATED KALLESTAD LABORATORIES, INC.
K772134 11/14/1977 SYRINGE, IRRIGATION, PRE-FILLED KENDALL RESEARCH CENTER
K772133 11/14/1977 URINE SPECIMEN COLLECTING DEVICE KENDALL RESEARCH CENTER
K772185 11/25/1977 LAPAROSCOPE W/REMOVABLE OPTICS KLI
K772176 11/21/1977 CYSTIC FIBROSIS TESTING INSTRUMENT LABORATORY EQUIPMENT DESIGN CO.
K772126 11/11/1977 TEMP. BRIDGE, POSTERIOR 3-UNIT LEE PHARMACEUTICALS
K772204 11/30/1977 EYEGLASS FRAMES LOGO PARIS, INC.
K772201 11/30/1977 HEARING AID, BODY TYPE, MODEL H MAICO HEARING INSTRUMENTS, INC.
K772064 11/02/1977 THYRODOT-4 ANTISERA LYOPHOLIZED MEDCOM DIAGNOSTICS, INC.
K772144 11/15/1977 CATHETER, DISP., EXTERNAL, MALE MEDLINE INDUSTRIES, INC.
K772138 11/14/1977 ENDOTRACHEAL TUBE MEDLINE INDUSTRIES, INC.
K772062 11/02/1977 NEONATAL FLOTATION SYSTEM MEDPRO, INC.
K772103 11/07/1977 BIPOLAR LEADS, DISP. MEDTRONIC VASCULAR
K772104 11/07/1977 PACING LEAD MODEL 6991A MEDTRONIC VASCULAR
K772202 11/30/1977 PULSE GENERATOR, A-V SEQ. MEDTRONIC VASCULAR
K772203 11/30/1977 VENTRICULAR LEADS MEDTRONIC VASCULAR
K772088 11/04/1977 AMES T-3 UPTAKE STRIP TEST MILES LABORATORIES, INC.
K772095 11/07/1977 HEMAGGLUTINATION INHIBITION TEST MILES LABORATORIES, INC.
K772099 11/07/1977 PRINTER MILES LABORATORIES, INC.
K772160 11/16/1977 ELECTROSURGICAL GROUNDING PAD NDM CORP.
K772116 11/07/1977 AMINOGLYCOSIDE TEST SYSTEM NICHOLS INSTITUTE DIAGNOSTICS
K772177 11/21/1977 TRI-TAB-RIA NUCLEAR MEDICAL LABORATORIES, INC.
K772065 11/02/1977 CRITICAL CARE VENTILATOR 2 OHIO MEDICAL PRODUCTS
K772181 11/25/1977 PROPHYLACTIC OM INDUSTRIES, INC.
K772086 11/03/1977 QUANTROLS HCG ORGANON, INC.
K772096 11/07/1977 IN VITRO DIAGNOSTIC REAGENT PCL-RIA, INC.
K772123 11/11/1977 TOMOGRAPHIC SYSTEM, COMPUTERIZED PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K772136 11/14/1977 PERITONEAL CYCLER & MANIFOLD SET PHYSIO-CONTROL CORP.
K772097 11/07/1977 HEARTRATE METER MODEL 650, P/N 000119 QUINTON, INC.
K772195 11/28/1977 HEMATOLOGY REFERENCE CONTROLS R & D SYSTEMS, INC.
K772066 11/01/1977 PULLEN PLASTIC-PORE PLUGS RICHARD'S MEDICAL EQUIP., INC.
K772168 11/08/1977 MOLDEYE ROBERT B. SCOTT OCULARISTS OF FLORIDA, INC.
K772171 11/18/1977 EAR PIERCING DEVICE ROBERT C. CAMERON
K772127 11/11/1977 OXYGEN MASK, AIR-ENTRAINMENT SALTER LABS
K772117 11/08/1977 HEAT EXCHANGER, DISP., OMNITHERM SCIMED LIFE SYSTEMS, INC.
K772149 11/14/1977 LANCER BIOPSY HOLDER SHERWOOD MEDICAL INDUSTRIES
K772121 11/10/1977 ASPIRATOR & PROBE, CYTOLOGY, ENDOMET. SMITH KLINE DIAGNOSTICS, INC.
K772148 11/14/1977 CATHETER, FEMORAL VEIN, SF 6 SORENSEN RESEARCH
K772146 11/14/1977 CATHETER, VEIN, FEMORAL, SF 10 SORENSEN RESEARCH
K772147 11/14/1977 GW 35 GUIDE WIRE SORENSEN RESEARCH
K772196 11/28/1977 RECEPTAL ATS TRAUMA KGA1900L SORENSEN RESEARCH
K772100 11/07/1977 HEARING AID-MODEL CE-2 STARKEY LABORATORIES, INC.
K772101 11/07/1977 HEARING AID-MODEL PE-1 STARKEY LABORATORIES, INC.
K772105 11/07/1977 PLATELET KIT STRECK LABORATORIES, INC.
K772182 11/25/1977 SURGICAL GOWN, REINFORCED SURGIKOS, INC.
K772178 11/22/1977 PACER MONITOR, PULSE WIDTH SURVIVAL TECHNOLOGY, INC.
K772164 11/17/1977 PANORAMIC X-RAY SYSTEM MODEL A SYBRON CORP.
K772179 11/23/1977 EMIT ANTIEPILEPTIC DRUG ASSAYS SYVA CO.
K772170 11/21/1977 EMIT CENTRIFICHEM THYROXINE ASSAY SYVA CO.
K772167 11/16/1977 EMIT LIDOCAINE CONTROL SYVA CO.
K772166 11/16/1977 EMIT THEOPHYLLINE CONTROL SYVA CO.
K772124 11/11/1977 LENSES, EYEGLASS, SAFETY TECHSIGHT CORP.
K772113 11/07/1977 URINARY DRAINAGE BAG 2D9017 TRAVENOL LABORATORIES, S.A.
K772198 11/29/1977 CT SCANNER DIAGNOSTIC CONSOLE, REMOTE VARIAN ASSOC., INC.
K772158 11/16/1977 LIGHT-PEN SYSTEM FOR QUANTI. ANALY. VARIAN ASSOC., INC.
K772165 11/16/1977 SPECTROPHOTOMETER - SERIES AA-575 VARIAN ASSOC., INC.
K772175 11/21/1977 CATHETER SYSTEM, COPE/EISENBERG VICTORY ENGINEERING CORP.


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