FDA 510(k) Decisions During July, 1977  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K770822 07/11/1977 A-GENT ALBUMIN ABBOTT LABORATORIES
K770594 07/06/1977 LABORATORY EXPENDABLE PRODUCTS ABCO DEALERS, INC.
K771134 07/05/1977 ANESTHESIA BREATHING CIRCUIT AIR PRODUCTS & CHEMICALS, INC.
K770873 07/11/1977 CIRCUMCISION KIT AMERICAN HOSPITAL SUPPLY CORP.
K771050 07/14/1977 HYPERALIMENTATION TRAY AMERICAN HOSPITAL SUPPLY CORP.
K771024 07/15/1977 CHOLINESTERASE REAGENT SYSTEM AMERICAN MONITOR CORP.
K770909 07/14/1977 ENZYMATIC CHOLESTEROL REAGENT SET AMERICAN MONITOR CORP.
K770824 07/15/1977 FLAME PHOTOMETER MOLEL 4600, KDA AMERICAN MONITOR CORP.
K771262 07/21/1977 PACEMAKER & CARDIAC LEAD, BIPOLAR ARCO MEDICAL PRODUCTS CO.
K771096 07/01/1977 TELHTHERAPY SIMULATOR AECL-CP, G-3200 ATOMIC ENERGY OF CANADA
K770983 07/29/1977 CATHETER THORACIC, AXIOM AXIOM MEDICAL, INC.
K771048 07/19/1977 CATHETERS, DRAINAGE AXIOM MEDICAL, INC.
K770652 07/06/1977 FLUORESCENCE ILLUMINATOR ACCESSORY BAUSCH & LOMB, INC.
K770722 07/11/1977 THROMBO SCREEN QUANTITATIVE HEPARIN ASSA BAY AREA HEMA. ONCO. CLINIC. & RES. L
K770980 07/11/1977 EMATOLOGY DILUENT RESERVOIR CLOSURE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K771058 07/01/1977 EPTONE BACK-UP BROTH, VACUTAINER BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K771061 07/05/1977 ODUFLEX AEROSOL SET BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K770877 07/21/1977 DATA REDUCTION SYSTEM, DP-3000 BECKMAN INSTRUMENTS, INC.
K770948 07/15/1977 LIPOPROTEIN PROFILING SYSTEM BECKMAN INSTRUMENTS, INC.
K770750 07/05/1977 REAGENT KIT, ENZYMATIC AMYLASE BECKMAN INSTRUMENTS, INC.
K770825 07/11/1977 SPECTROPHOTOMETERS,34,35,36,3600 BECKMAN INSTRUMENTS, INC.
K771135 07/14/1977 QUANTIMUNE NEONATAL & THYROXINE RIA BIO-RAD
K770774 07/11/1977 LYTETEK SYSTEM BOEHRINGER MANNHEIM CORP.
K771254 07/15/1977 ACCU. CROWN COLD CURE BRIAR CLIFF, INC.
K771139 07/14/1977 CRP-WELLCOTEST BURROUGHS WELLCOME CO.
K771149 07/27/1977 ENDOMETRIAL ASPIRATION BIOSPY KIT 182341 C.R. BARD, INC.
K770953 07/14/1977 MONITOR, AERATION, TEC-TEST CASTLE CO.
K771028 07/05/1977 ANALYZER, OXYGEN, MODEL OM-92 CAVITRON CORP.
K770900 07/21/1977 CAST BRWM, FRACTURE CHASE MFG. CO.
K770898 07/21/1977 FRACTURE CAST BRACE KIT, PLASTIC CHASE MFG. CO.
K770899 07/21/1977 FRACTURE CAST BRACE, POLY CHASE MFG. CO.
K770723 07/11/1977 TABLE, TREATMENT, THERAPY, PHYSICAL CHATTANOOGA PHARMACAL CO.
K770724 07/11/1977 TRACTION DEVICES, INTERMITTENT, TX CHATTANOOGA PHARMACAL CO.
K770780 07/11/1977 REAGENTS CHEMETRICS CORP.
K771118 07/11/1977 CENTRIA SEPARATION COLUMNS TYPE A CLINICAL DIAGNOSTICS, INC.
K771015 07/11/1977 VYGON RED-O-PACK COASTAL BEND MEDICAL PRODUCTS, INC.
K770852 07/14/1977 SYRINGE, BLOOD SAMPLING, ARTERIAL, #4015 CONCORD LABORATORIES, INC.
K770851 07/14/1977 SYRINGE, BLOOD SAMPLING, ARTERIAL, #4016 CONCORD LABORATORIES, INC.
K770850 07/15/1977 TRAY, BLOOD GAS, ARTERIAL, #4014 CONCORD LABORATORIES, INC.
K770792 07/05/1977 TUBE, STAIN, RETICULOCYTE, LARC CORNING MEDICAL & SCIENTIFIC
K771070 07/14/1977 DRY HEAT STERILIZER CPAC, INC.
K771071 07/14/1977 PORTO-VAC CPAC, INC.
K770972 07/15/1977 CARDIOZYME CK-TOTAL REAGENTS DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K771214 07/15/1977 SUPERFINE DIAMONDS DEN-MAT CORP.
K771179 07/15/1977 BIOBOND MASTER STAIN AND GLAZE KIT DENTSPLY INTL.
K771009 07/13/1977 ELECTRO-SURGICAL DEVICES DESERET PHARMACEUTICAL CO.
K771097 07/14/1977 FORCEP, DISP., A CLAMP DRAVON MEDICAL, INC.
K770730 07/11/1977 PUMP, INFUSION, DYNATECH/HANDLEY DYNATECH MEDICAL PRODUCTS
K771142 07/14/1977 T3 CLASP RIA KIT E. R. SQUIBB & SONS, INC.
K771233 07/15/1977 PHENYTOIN ANALYTICAL TEST PACKS E.I. DUPONT DE NEMOURS & CO., INC.
K771223 07/14/1977 GRAY TONE IMAGING FILM EASTMAN KODAK COMPANY
K771190 07/11/1977 ABRAMSON TRACHEA HOOK & RETRACTOR EDWARD WECK, INC.
K771187 07/11/1977 DERMAHOOK #382-805 EDWARD WECK, INC.
K771191 07/11/1977 HEISS RETRACTOR EDWARD WECK, INC.
K771189 07/11/1977 HOT TEMP CAUTERY EDWARD WECK, INC.
K771192 07/11/1977 LOWMAN BONE FORCEP EDWARD WECK, INC.
K771186 07/15/1977 MICRO BI-POLAR FORCEPS #39-200 EDWARD WECK, INC.
K770686 07/14/1977 THERATHERM ELECTRO THERAPEUTIC DEVICES, INC.
K771013 07/01/1977 MOSQUITO EMDE CORP.
K771067 07/21/1977 CHOLESTEROL KIT ENVIRONMENTAL CHEMICAL SPECIALTIES
K771068 07/12/1977 TRIGLYCERIDE KIT ENVIRONMENTAL CHEMICAL SPECIALTIES
K771119 07/15/1977 PASTES, RESTORATIVE & TINTED, DEBTAL ESPE DENTAL PRODUCTS
K771057 07/05/1977 ANESTHESIA MACHINE FOREGGER
K771287 07/21/1977 FINGEO EXTENSION SPLINTS FRED SAMMONS, INC.
K771288 07/21/1977 JAMAR DYNAMOMETEO BK-7498 FRED SAMMONS, INC.
K771274 07/21/1977 QUADRIPLEGIC MEAT KNIFE FRED SAMMONS, INC.
K770773 07/11/1977 PIPETTE, DILUTING, MODEL ADP-30SD G.D. SEARLE AND CO.
K770772 07/11/1977 PIPETTE, DISPENSING, MODEL ADP-30SD G.D. SEARLE AND CO.
K771238 07/15/1977 RID PLATES & INTENSI. FOR HUMAN IGE ETC G.D. SEARLE AND CO.
K771083 07/21/1977 SEQUENTIAL PRESSURE CUFF GAYMAR INDUSTRIES, INC.
K770680 07/01/1977 HEMATRAK GEOMETRIC DATA, DIV. SMITHKLINE CORP.
K771062 07/14/1977 EBV TEST GULL LABORATORIES, INC.
K771063 07/11/1977 HSV TEST GULL LABORATORIES, INC.
K770944 07/27/1977 INSTATEMP H.I. SILVERMAN, D.SC.
K771018 07/14/1977 TRANS 2000 HAMILTON INDUSTRIES, INC.
K770887 07/14/1977 AUTO TOTAL PROTEIN FOR ANALYZER HARLECO
K770886 07/14/1977 AUTO-ENZYMATIC GLUCOSE FOR ANALYZER HARLECO
K771131 07/21/1977 CLINICARD UV AMYLASE CHEMISTRY HARLECO
K770816 07/11/1977 ULTRACHEM ALBUMIN HARLECO
K770817 07/11/1977 ULTRACHEM CALCIUM HARLECO
K770819 07/11/1977 ULTRACHEM CREATININE HARLECO
K770820 07/11/1977 ULTRACHEM INORGANIC PHOSPHORUS HARLECO
K770870 07/14/1977 ULTRAZYME PLUS ALP HARLECO
K770883 07/14/1977 ULTRAZYME PLUS GOT HARLECO
K770882 07/14/1977 ULTRAZYME PLUS GPT HARLECO
K770815 07/11/1977 ULTRAZYME PLUS GT HARLECO
K770871 07/14/1977 ULTRAZYME PLUS HBD HARLECO
K770818 07/11/1977 ULTRAZYME PLUS, LDH HARLECO
K771094 07/21/1977 UNIPAK ALBUMIN HARLECO
K771087 07/21/1977 UNIPAK BUN HARLECO
K771093 07/21/1977 UNIPAK CHOLESTEROL HARLECO
K771091 07/21/1977 UNIPAK GLUCOSE HARLECO
K771090 07/11/1977 UNIPAK HEMOGLOBIN HARLECO
K771092 07/21/1977 UNIPAK TOTAL & DIRECT BILIRUBIN HARLECO
K771089 07/21/1977 UNIPAK TOTAL BILIRUBIN HARLECO
K771088 07/21/1977 UNIPAK URIC ACID HARLECO
K770694 07/01/1977 CPK ULTRAZYME PLUS HARLECO DIAGNOSTICS
K771357 07/29/1977 GROUP AUDITORY TRAINER HC 431R HC ELECTRONICS
K771356 07/29/1977 POST-AURICULAR HEARING AID HC 880 HC ELECTRONICS
K770830 07/11/1977 PLATELET AGITATOR HELMER LABS, INC.
K771000 07/15/1977 TRENDAR HI CHEM, INC.
K771105 07/05/1977 NEBULIZER, MOLEL 503, PART #17068 HOSPAL MEDICAL CORP.
K771110 07/15/1977 HERITAGE SPECIAL ALLOY HOWMEDICA CORP.
K770690 07/21/1977 MASK, VAPOR, MONOMER HOWMEDICA CORP.
K770982 07/15/1977 UNITED SKIN BARRIER HOWMEDICA CORP.
K771185 07/15/1977 PERIODONTIC TOOTHBRUSH, #0126-0190-00 HOYT LABORATORIES
K771184 07/15/1977 TOOTHBRUSH, ORTHODONTIC, #0126-0189-00 HOYT LABORATORIES
K771183 07/15/1977 TOOTHBRUSH, PEDODONTIC, #0126-0188-00 HOYT LABORATORIES
K771107 07/11/1977 COUNTER 700 & HC-700 HEMO 0 REF. HYCEL, INC.
K771154 07/21/1977 CPK-INT TEST HYCEL, INC.
K770803 07/05/1977 HEMOTOLOGY PRODU&TS (5 IN ALL) HYCEL, INC.
K771226 07/21/1977 LAS-R TEST PROGRAM HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K771044 07/15/1977 TMA BICARBONATE DILUENT HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K770438 07/01/1977 CART, PROCEDURES I E INDUSTRIES
K771080 07/14/1977 STEAM STERILIZATION INDICATOR INFO-CHEM
K770946 07/05/1977 RECORD, MODEL 702, I.L. INSTRUMENTATION LABORATORY CO.
K771257 07/15/1977 ACRY TEMP INTERSTATE DENTAL CO., INC.
K771248 07/15/1977 SILICONE IMPRESSION MATEOIAL INTERSTATE DENTAL CO., INC.
K770664 07/05/1977 NEBULIZER J & S INDUSTRIES, INC.
K771344 07/27/1977 GUSBERG HYSTERECTOMY CLAMP J. SKLAR MFG. CO., INC.
K771060 07/21/1977 DIAG. CONDUCTA RATE BUN REAG. SET J.T. BAKER CHEMICAL CO.
K771059 07/21/1977 DIAG. OZYRATE GLUCOSE REAG. SET J.T. BAKER CHEMICAL CO.
K771108 07/29/1977 NEEDLE, CHIBA UNIVERSITY JOHANNAH MEDICAL SERVICES, INC.
K771144 07/14/1977 RHODAMINE-CONJUGATED ANTISERUM KENT LABORATORIES, INC.
K771252 07/15/1977 CB600, TURBINE CONTROL BOL LITTON DENTAL PRODUCTS
K771251 07/15/1977 HU:500, HYGIENASSIST LITTON DENTAL PRODUCTS
K770795 07/11/1977 SHAVE PREP SET LUKENS CORP.
K770797 07/11/1977 TRAY, CATHETERIZATION W/FOLEY, STERILE LUKENS CORP.
K771249 07/15/1977 JOY LIGHT M.D. INTL., INC.
K770844 07/14/1977 FLUCOSE U.V. TEST KIT MALLINCKRODT CRITICAL CARE
K771066 07/11/1977 CATHETER, SAMPLING, CONDUIT MENTOR CORP.
K770764 07/21/1977 TISSUE CULTURE MEDIA W/HEPES BUFFER MICROBIOLOGICAL ASSOC.
K771035 07/05/1977 CULTURE TEST FOR NEISSERIA GONORRHOEAE MILES LABORATORIES, INC.
K770984 07/05/1977 TA-2 TEMPERATURE ALARM MISTOGEN EQUIPMENT CO.
K771036 07/14/1977 SHAVE PREP TRAY PARKE-DAVIS CO.
K771130 07/15/1977 DESENSITRON PARKER LABORATORIES, INC.
K770942 07/21/1977 PHADECODE DIFFERENTIAL FACTOR XA1 ASSAY PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K771136 07/14/1977 SURGICAL HEAD DRAPE, DISP. PROCTER & GAMBLE MFG. CO.
K771157 07/21/1977 RM VI-HV RICH-MAR CORP.
K770517 07/15/1977 NF DEVICE RPR, INC.
K770981 07/11/1977 LANCER CAPILLARY BLOOD SERUM SEPARATOR SHERWOOD MEDICAL INDUSTRIES
K770902 07/14/1977 COLORIMETRIC DETERM. SOCITRATE DEHYDRO. SIGMA CHEMICAL CO.
K770849 07/14/1977 VOLUMET INFUSION PUMP, MODIFI. OF SIGMAMOTOR, INC.
K770767 07/05/1977 IN VITRO DIAG. FOR URIC ACID SMITH KLINE DIAGNOSTICS, INC.
K771042 07/13/1977 INTRODUCER, CAT. #INT-05FR. SORENSEN RESEARCH
K771041 07/13/1977 INTRODUCER, CAT. #INT-06FR. SORENSEN RESEARCH
K771246 07/15/1977 ALARM SYS FOR NITROUS OXIDE SYS. STAR DENTAL MFG. CO.
K771247 07/15/1977 CORE MATERIAL STAR DENTAL MFG. CO.
K771128 07/15/1977 NEKO CERAMIC CONVENIENCE CROWNS STERNDENT CORP.
K771200 07/21/1977 ORTHOSCOPE STRYKER CORP.
K771199 07/25/1977 SURGIPULSE HEART RATE MONITOR STRYKER CORP.
K771032 07/14/1977 POUCHES, PEEL OPEN, BREATHABLE SURGICOT, INC.
K771188 07/14/1977 REVERSING CLICK GENERATOR RCG6 TECA, INC.
K770695 07/14/1977 MONITOR, BED, TECHNOLICS TECHNOLICS, INC.
K771206 07/15/1977 AV FISTULA NEEDLE SET TERUMO AMERICA, INC.
K771203 07/14/1977 DISP. HYPODERMIC NEEDLE TERUMO AMERICA, INC.
K771211 07/14/1977 DOPPLER (UTD-5 & UTD-6) TERUMO AMERICA, INC.
K771205 07/14/1977 HYPODERMIC SYRINGE TERUMO AMERICA, INC.
K771204 07/14/1977 SURFLO WINGED INFUSION SET TERUMO AMERICA, INC.
K771209 07/26/1977 TERUFUSION BLOOD ADMIN. SET TERUMO AMERICA, INC.
K771207 07/14/1977 TERUFUSION DONOR SET TERUMO AMERICA, INC.
K771210 07/11/1977 UROGARD URINARY DRAINAGE BAG TERUMO AMERICA, INC.
K770917 07/14/1977 GLUTAMATE OXALACETIC TRANSAMINASE THE DOW CHEMICAL CO.
K771101 07/21/1977 HEMOGLOBIN ANALYZER & PERFORM. CHECK SET THE DOW CHEMICAL CO.
K770889 07/11/1977 BURN DRESSING KIT THE OWENBY CO.
K770907 07/05/1977 SPIROMETEO EXHAUST TIMETER INSTRUMENT CORP.
K771027 07/05/1977 ELECTROCARDIOGRAPHIC PATIENT CABLES TRONOMED, INC.
K771216 07/21/1977 CENTRIFICHEM TRIGLYCEOIDE CALI, STD. SET UNION CARBIDE CORP.
K771215 07/21/1977 CENTRIFICHEM TRIGLYCERIDE CALI. STD. UNION CARBIDE CORP.
K770841 07/14/1977 TRIGLYCERIDE ENZYMATIC METHOD UNION CARBIDE CORP.
K770954 07/01/1977 UNIVUE I UNION CARBIDE CORP.
K770827 07/21/1977 CHROMATOGRAPHY ANALYSIS SYS, MODEL 8500 VARIAN ASSOC., INC.
K771202 07/21/1977 WALPEO TABLH WALPEO CORP.
K771181 07/14/1977 VAGINAL ILLUMINATOR, MODEL 78570 WELCH ALLYN, INC.
K771132 07/14/1977 KENWOOD BIOLOGICAL STEOILIZ. INDICATOR WILL ROSS CO.
K771145 07/15/1977 WILL-CERAM W-2 WILLIAMS GOLD REFINING CO., INC.
K771143 07/11/1977 INORGANIC PHOSPHORUS STANDARDS WORTHINGTON BIOCHEMICAL CORP.
K771001 07/11/1977 STATZYME GLUCOSE WORTHINGTON BIOCHEMICAL CORP.
K770831 07/11/1977 STATZYME URIC ACID REAGENT WORTHINGTON BIOCHEMICAL CORP.
K771106 07/01/1977 FORCEPS, OB, NON-COMPRESSIVE ZEPPELIN MEDIZINLECHNIK GMBH


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