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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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flo-gard 8000 infusion pump system TRAVENOL LABORATORIES, S.A. k813403 12/31/1981
quantafluor fluorescent test reagents KALLESTAD LABORATORIES, INC. k813592 01/18/1982
pressure infuser DAVID CLARK COMPANY, INC. k820159 04/21/1982
delta plan ii radiation therapy plan TECHNICARE CORP. k820310 03/31/1982
william harvey h-625 arterial filter C.R. BARD, INC. k820472 03/15/1982
disposable tubing sets INNOVATIVE SURGICAL PRODUCTS INC. k820680 04/09/1982
thermo-k AMERICAN MEDICAL SYSTEMS, INC. k820814 04/29/1982
biopsy forceps w/oval cups MILL-ROSE LABORATORY k820972 04/26/1982
bite stick ABCO DEALERS, INC. k821177 05/21/1982
sgpt-uv reagent set OMEGA MEDICAL ELECTRONICS k821206 07/22/1982

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