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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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Applicant
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510(K)
Number
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Decision
Date
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emit-aad theophylline assay SYVA CO. k813240 12/03/1981
hemodialysis system FHK k813432 06/23/1982
indeflator ADVANCED CATHETER SYSTEMS k813622 01/22/1982
phenobarbital assay SYVA CO. k820188 02/05/1982
pilling identi-loops NARCO SCIENTIFIC k820377 03/10/1982
mainflow bacteria filter OMNICON MEDICAL CORP. k820576 03/18/1982
hollow fiber dialyzers TERUMO MEDICAL CORP. k820743 06/23/1982
teca model sensor er 94 TECA, INC. k820908 05/03/1982
hawkins electrokinetic body activating LEISURE WAY k820938 06/11/1982
tsh-squibb radioimmunoassay kit SQUIBB & SONS, INC. k821174 05/14/1982

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