FDA 510(k) Applications Received During December, 1978

FDA 510(k) Number Submission Date Device Name Applicant Contact
K782115 12/27/1978 ASTRA-VAC AB ASTRA
K782015 12/05/1978 A-GENT CK-MB ABBOTT LABORATORIES
K782014 12/05/1978 ANALYZER ABA-200 ABBOTT LABORATORIES
K782049 12/08/1978 BIOASSAY SYSTEM, MS-2 SERUM ABBOTT LABORATORIES
K782008 12/01/1978 DRESSING, ENVIRON WOUND ABBOTT LABORATORIES
K782013 12/05/1978 GONO-CELL ABBOTT LABORATORIES
K782113 12/19/1978 CAP, TAMPER PROOF PLASTIC ACACIA, INC.
K782005 12/04/1978 RADIATION ONCOLOGY SYSTEM ADAC LABORATORIES
K782136 12/27/1978 GLUCOSE REAGENT SYSTEM AMERICAN MONITOR CORP.
K782118 12/27/1978 FUL-VUE AMERICAN OPTICAL CORP.
K782064 12/13/1978 TABLE, EXAMINING-TWO EIGHTY AMSCO CO.
K782092 12/14/1978 ARMBOARD CVER, DISPOSABLE ANAGO, INC.
K782144 12/27/1978 DISPOSABLE SURGICAL INSTRUMENT TIP ANAGO, INC.
K782091 12/14/1978 STOCKINETTE, DISPOSABLESURGICAL ANAGO, INC.
K782073 12/13/1978 DINAMAP MODELS 1160 AND 1165 APPLIED MEDICAL RESEARCH
K782146 12/27/1978 PACEMAKER, MODEL DDP ELECTRONIC CIRCUIT ARCO MEDICAL PRODUCTS CO.
K782129 12/27/1978 LUPO-TEC ARMKEL, LLC.
K782001 12/04/1978 ROSEALAE ASMB
K782034 12/06/1978 INFUSION PUMP, MODEL AS*5 BAXTER HEALTHCARE CORP.
K782138 12/27/1978 MONITOR, BECKMAN LB-3CO2 BECKMAN INSTRUMENTS, INC.
K782037 12/06/1978 SERACON-A BHP DIAGNOSTIX, INC.
K782038 12/06/1978 SERACON-C BHP DIAGNOSTIX, INC.
K782171 12/29/1978 SERACON-HDL BHP DIAGNOSTIX, INC.
K782170 12/29/1978 SERACON-LP BHP DIAGNOSTIX, INC.
K782039 12/06/1978 SERACON-N BHP DIAGNOSTIX, INC.
K782145 12/27/1978 SPIROMETER, MINI POSITIVE BOEHRINGER LABORATORIES
K782032 12/06/1978 UNITEST AMYLASE BOEHRINGER MANNHEIM CORP.
K782156 12/22/1978 UNITEST CREATINE KINASE BOEHRINGER MANNHEIM CORP.
K782067 12/13/1978 DILATOR, MIZUTANI LAMINARIA TENT BRITISH MARKETING ENT., LTD.
K782059 12/07/1978 TRANSMITTER, TR-1 ECG BURDICK CORP.
K782082 12/14/1978 CATHETER, DIGITAL POSITRAL II C.R. BARD, INC.
K782071 12/13/1978 CATHETER, USCI GRUNTZIG/BALLOON C.R. BARD, INC.
K782107 12/19/1978 LAP SPONGE CARAPACE, INC.
K782022 12/05/1978 MICROLITH A MODEL 703 CARDIAC PACEMAKERS, INC.
K782023 12/05/1978 MICROLITH A MODEL 803 CARDIAC PACEMAKERS, INC.
K782062 12/07/1978 ANALYZER, OXYGEN MODEL M25RA & M25RAD CATALYST RESEARCH CORP.
K782080 12/13/1978 VENEER SYSTEM, MOSTIQUE LAMINATE CAULK CO., DIV. DENTSPLY
K782054 12/07/1978 LASER, CO2 SURGICAL CAVITRON CORP.
K782065 12/13/1978 LASER, PHOTOCOAGULATION CAVITRON CORP.
K782153 12/26/1978 IMPRESSION TRAY, MDDS CUSTOM CHAYET AND SONNENRICH, P.C.
K782109 12/19/1978 RIA KIT, GAMMACOAT CLINICAL ASSAYS, INC.
K782163 12/21/1978 THE BLUE MASK COLLECTOVAC, INC.
K782036 12/05/1978 TREMOR MONITOR COLUMBUS INSTRUMENTS INTL. CORP.
K782046 12/08/1978 C-CORD CONCEPT, INC.
K782090 12/14/1978 CLAMP, DISPOSABLE CONCORD LABORATORIES, INC.
K782155 12/22/1978 GENERAL EQUIPMENT COVER CONTOUR FABRICATORS, INC.
K782021 12/05/1978 A.V. FISTULA NEEDLE SET CORDIS CORP.
K782151 12/26/1978 ARTIFICIAL KIDNEY, C-DAK 0.6D CORDIS CORP.
K782114 12/20/1978 MONITOR, OXYCHEK OXYGEN CRITIKON COMPANY,LLC
K782150 12/26/1978 FLUROMETER, DADE DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K782098 12/18/1978 REAGENT, LYSING AND HEMOGLOBIN DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K782122 12/27/1978 HEARING AID, MODEL AA DAHLBERG ELECTRONICS, INC.
K782121 12/27/1978 HEARING AID, MODEL GB DAHLBERG ELECTRONICS, INC.
K782087 12/14/1978 LEAD, SUTURELESS MYOCARDIAL DAIG CORP.
K782004 12/04/1978 LEAD, TIMED PACING, IMPLANTABLE DAIG CORP.
K782124 12/27/1978 IEC CENTRA-7 CENTRIFUGE MODEL 2362 DAMON CORP.
K782026 12/05/1978 FLAT SILICONE DRAIN DAVOL, INC.
K782027 12/05/1978 HYSTERECTOMY "T" DRAIN DAVOL, INC.
K782028 12/05/1978 ROUND SILICONE DRAIN DAVOL, INC.
K782068 12/13/1978 MVS UNIT, MODEL SEU-8 AND DEU-8, "80" DENTSPLY INTL.
K782123 12/27/1978 MULTIPLICITY OF PRODUCTS DEPUY, INC.
K782172 12/29/1978 BRUSH/SPONGE, DISPOSABLE DEXIDE, INC.
K782173 12/29/1978 SURGERY BRUSH DEXIDE, INC.
K782125 12/27/1978 RIA KIT, KANAMYCIN DIAGNOSTIC PRODUCTS CORP.
K782126 12/27/1978 RIA KIT, SISOMICIN DIAGNOSTIC PRODUCTS CORP.
K782058 12/07/1978 CATHETER, BETA-CAP-PERITONEAL DRAVON MEDICAL, INC.
K782057 12/07/1978 CATHETER, RADIOPAQUE TENCKHOFF DRAVON MEDICAL, INC.
K782130 12/27/1978 MINI-DILUTER 2 DYNATECH LABORATORIES, INC.
K782128 12/27/1978 THERA CHEM FISHER SCIENTIFIC CO., LLC.
K782160 12/21/1978 TOTAL IRON IN SERUM FISHER SCIENTIFIC CO., LLC.
K782029 12/05/1978 MAXI CAMERA 400T GENERAL ELECTRIC CO.
K782093 12/14/1978 DETECTOR PAD HALPERIN INSTITUTE, LTD, THE
K782053 12/07/1978 HEARING AID, POST-AURICULAR HC ELECTRONICS
K782076 12/13/1978 HT-110 MICROMINI HEALTH TECH
K782035 12/06/1978 HEMESPEC HELENA LABORATORIES
K782094 12/14/1978 HILAR HI CHEM, INC.
K782105 12/19/1978 CATHETERS, H-H VENTRICULAR HOLTER-HAUSNER INTL.
K782158 12/22/1978 SCANNER-SV HRL, INC.
K782102 12/18/1978 HYCEL COUNTER 211 HYCEL, INC.
K782101 12/18/1978 HYCEL COUNTER 222 HYCEL, INC.
K782100 12/18/1978 HYCEL COUNTER 333 HYCEL, INC.
K782176 12/28/1978 HYCEL LDH-INT TEST HYCEL, INC.
K782116 12/27/1978 KETOSTEROID TEST, HYCEL-17 HYCEL, INC.
K782070 12/12/1978 REAGENT, COCCI LATEX I M, INC.
K782041 12/07/1978 FIAX TEST KIT IDT, A DIVISION OF WHITTAKER M.A. BIOPRODUCTS
K782033 12/06/1978 CARDIAC CARE Q/C TEST KIT INSTRUMENTATION LABORATORY CO.
K782112 12/18/1978 PADS, MINI, MAXI INTL. PLAYTEX, INC.
K782111 12/18/1978 PADS, MINI, MAXI DEODORANT INTL. PLAYTEX, INC.
K782164 12/22/1978 STIMULATOR, MODEL 1-600 ELECTRIC NERVR IPCO CORP.
K782081 12/13/1978 RIA SYSTEM, PARATHYROID HORMONE ISO-TEX DIAGNOSTICS
K782003 12/04/1978 BAND AID* ADHESIVE BANDAGES JOHNSON & JOHNSON PROFESSIONALS, INC.
K782052 12/07/1978 PROCESSOR, K750 COMPUTER/DATA KALLESTAD LABORATORIES, INC.
K782141 12/27/1978 LEVIGATOR, KEELER PHOKO KEELER OPTICAL PRODUCTS LTD.
K782002 12/04/1978 TRACH-COLLAR KINETIC CONCEPTS, INC.
K782030 12/05/1978 LASER SYSTEM, SHARPLAN 791/HE, CO2 LASER INDUSTRIES LTD.
K782106 12/13/1978 COAGULATOR, MODEL 40 AARGON LASERTEK OY
K782159 12/22/1978 DIAGNOSTIC KIT, FERRITAB-FE-59 LEECO DIAGNOSTICS, INC.
K782154 12/22/1978 COLOSTOMY DEVICE, MACLET MAGNETIC MACLET MEDICAL DEVICES, INC.
K782051 12/08/1978 DRAPES, DISPOSABLE SURGICAL MARCO MFG.
K782016 12/05/1978 SPIROCARE 108-B MARION LABORATORIES, INC.
K782119 12/27/1978 DEBUTRON MARTIN ELECTRIC CO.
K782066 12/13/1978 EXETRELUT MCB MANUFACTURING CHEMISTS, INC.
K782140 12/27/1978 REMOVER, SOFT-SERT CONTACT LENS MCMURRAY AND PENDERGOST
K782133 12/27/1978 ODONTOSON 3 MDT CORP., INC.
K782006 12/01/1978 MEDGENERAL SINGLE-USE BULLDOG MED GENERAL
K782132 12/27/1978 PLETHYSMOGRAPH, STRAIN GAUGE MEDASONICS, INC.
K782168 12/29/1978 3-WAY STOPCOCK MEDEX, INC.
K782167 12/29/1978 DELTA FLOW MEDEX, INC.
K782048 12/08/1978 TEST KIT, IIF-ANA MEDICA CORP.
K782060 12/08/1978 MULTIFORMAT FILM CASSETTE TRANSPORT MEDISCAN, INC.
K782120 12/27/1978 SPONGE SYSTEM, ROSERING CONTAIN-COUNT MEDLINE INDUSTRIES, INC.
K782137 12/27/1978 MEDTRONIC MODEL 3797 ELECTRODE MEDTRONIC VASCULAR
K782108 12/19/1978 MEDTRONIC MODEL 546 MEDTRONIC VASCULAR
K782047 12/08/1978 PROCESSING SYSTEM, A2 IMAGE MEDTRONIC VASCULAR
K782075 12/13/1978 STIMULATOR, MODEL 7727 MEDTRONIC VASCULAR
K782043 12/08/1978 INDICATOR, BIPOLAR TEMPERATURE MICRONEX, INC.
K782095 12/18/1978 STOPCOCKS, MANIFOLDS NAMIC
K782152 12/26/1978 VALVE, AMBU PEEP NARCO AIR-SHIELDS
K782110 12/19/1978 RIA KIT, RIANEN CORTISOL NEW ENGLAND NUCLEAR
K782010 12/01/1978 HORMONE KIT, PARATHYROID NICHOLS INSTITUTE DIAGNOSTICS
K782157 12/22/1978 IRMA TEST, NORDICLAB FERRITIN NORDICLAB INTL.
K782099 12/18/1978 RIA TEST, NORDICALB HPL NORDICLAB INTL.
K782063 12/11/1978 PREGNANCY, SENSIDEX TUBE TEST ORTHO DIAGNOSTICS, INC.
K782166 12/29/1978 SLIDE TEST FOR PREGNANCY, GRAVINDEX 90 ORTHO DIAGNOSTICS, INC.
K782018 12/05/1978 LEADS, IMPLANTABLE CARDIAC PACEMAKERS OSCOR INC.
K782148 12/22/1978 HR UNIT PARKE-DAVIS CO.
K782055 12/11/1978 CREAM, SIGNA PARKER LABORATORIES, INC.
K782086 12/14/1978 AM-PEN SCREEN PFIZER, INC.
K782069 12/13/1978 TRAY, AUXILLARY BLOCK PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K782165 12/26/1978 PHASEAFILL PHASEALLOY
K782139 12/27/1978 ZYLOX PREMIER DENTAL PRODUCTS CO.
K782117 12/27/1978 MARTIN-LEWIS MEDIUM PREPARED MEDIA LABORATORY, INC.
K782079 12/13/1978 ELECTRODE SYSTEM, QUIK-PREP QUINTON, INC.
K782072 12/13/1978 QUINTON STATUS 1000 QUINTON, INC.
K782089 12/14/1978 MONITOR, HEART RATE MODEL 103 ROCHE MEDICAL ELECTRONICS, INC.
K782088 12/14/1978 MONITOR, HEART RATE MODEL 105 ROCHE MEDICAL ELECTRONICS, INC.
K782074 12/13/1978 VENTILATOR, MODEL AVA-1, ADULT RULE MEDICAL INSTRUMENTS, INC.
K782045 12/08/1978 MONITOR HS7 SCIENTIFIC & GENERAL PTY. LTD.
K782044 12/08/1978 MONITOR HS8 SCIENTIFIC & GENERAL PTY. LTD.
K782143 12/27/1978 RIA KIT, GLUCOSE SERONO LABORATORIES, INC.
K782103 12/15/1978 RIA KIT, NEONATAL T4 SERONO LABORATORIES, INC.
K782077 12/13/1978 LANCER ICE CUBE SHERWOOD MEDICAL INDUSTRIES
K782019 12/05/1978 CUTTER 888-00 INFUSION PUMP SIGMAMOTOR, INC.
K782020 12/05/1978 INFUSION PUMP, MODEL 5000 SIGMAMOTOR, INC.
K782127 12/27/1978 STIMULATOR, ELECTRICAL NERVE SOMATRONICS, INC.
K782007 12/01/1978 ROTARY SCALER STAR DENTAL MFG. CO.
K782061 12/11/1978 SPINAL SURGERY INSTRUMENTATION STUART DRUG & SURGICAL SUPPLY, INC.
K782084 12/14/1978 EMIT PROCAINAMIDE CONTROL SET SYVA CO.
K782085 12/14/1978 EMIT THYROXINE ASSAY SYVA CO.
K782025 12/05/1978 GENTAMICIN FLUROIMMUNASSAY KIT TECHNIA DIAGNOSTICS LTD.
K782024 12/05/1978 RIA KIT, VITAMIN B12 TECHNIA DIAGNOSTICS LTD.
K782050 12/08/1978 PRINTER, TEK PRO TEK TALLY II TEKPRO
K782162 12/21/1978 BATTERY CHARGER, 171 PACEMAKER TELECTRONICS, INC.
K782097 12/18/1978 ELECTRODE LEAD MODEL 030-198 TELECTRONICS, INC.
K782149 12/26/1978 PULSE GENERATOR, IMPLANTABLE CARDIAC TELECTRONICS, INC.
K782161 12/21/1978 PULSE GENERATOR, MODEL 171 TELECTRONICS, INC.
K782009 12/01/1978 RIA KIT, PROGESTERONE THE UPJOHN CO.
K782174 12/19/1978 PRESSURE ALARM THOMPSON RESPIRATION PRODUCTS, INC.
K782134 12/27/1978 FILTER FOR HYPERALIMENTATION SET TRAVENOL LABORATORIES, S.A.
K782083 12/14/1978 VAGATEX VAGATEX
K782131 12/27/1978 PULSETAKER VAN, COTT, BAGLEY, CORNWALL & MCCARTH
K790243 12/29/1978 CANNULAS VISITEC CO.
K790244 12/29/1978 CYSTOTOMES VISITEC CO.
K782169 12/29/1978 NEEDLES, CANNULAS, CYSTOTOMES VISITEC CO.
K782056 12/11/1978 CORD, ENTEROBACTERIACEAE BIOCHEMICAL VITEK SYSTEMS, INC.
K782175 12/28/1978 CARTRIDGE HOLDER, RCM 100 WATERS ASSOC., INC.
K782142 12/27/1978 ILLIMINATOR, MODEL 265 NASAL WELCH ALLYN, INC.
K782104 12/19/1978 PASTE, PRO CARE PROPHYLAXIS YOUNG DENTAL MANUFACTURING CO 1, LLC.
K782096 12/18/1978 INSTRUMENTS, OVERREFRACTION SYSTEM ZEISS HUMPHREY SYSTEM


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