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U.S. Department of Health and Human Services

510(K) Premarket Notification

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Device Name
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510(K)
Number
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Decision
Date
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akro-sil foley kit 5cc LATEX IND., INC. k771651 09/20/1977
iridium 192 wires & pins CIS RADIOPHARMACEUTICALS, INC. k771878 10/27/1977
in vitro digoxin ria test CLINICAL ASSAYS, INC. k772110 11/22/1977
ekg acquisition & analysis cart INTL. BUSINESS MACHINES k772353 01/06/1978
catheter/hemostatic/geriatric KENDALL RESEARCH CENTER k780062 02/14/1978
traction units BIOMET, INC. k780228 02/23/1978
pantridge mk iii defibrillator/monitor IPCO CORP. k780416 04/21/1978
125-i labeled human luteinizing hormone PCL-RIA, INC. k780576 05/19/1978
o2 connector DIEMOLDING CORP. k780750 07/27/1978
bun test uni-uv blood urea nitrogen test SCLAVO, INC. k780943 07/27/1978

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