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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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flame photometer standard #60083 160 na/8k In Vitro Diagnostics, Inc. k871184 05/28/1987
titan gel immunofix controls Helena Laboratories k871498 04/29/1987
summit optics post-mydriatic spectacles Summit Optics, Inc. k871800 06/11/1987
william harvey hf5000 membrane oxygenator Minntech Corp. k872107 08/28/1987
vision(r) total bilirubin Abbott Laboratories k872487 08/21/1987
filtral 10, filtral 12, filtral 16 hemodialyzer Hospal Medical Corp. k872767 12/29/1987
mam-cp x-ray apparatus Transworld X-Ray Corp. k872980 08/27/1987
brain heart infusion broth w/6.5% nac1 - #t3802 Lakewood Biochemical Co., Inc. k873218 09/23/1987
sutureless temporary epicardial pacing lead Symbion, Inc. k873474 10/07/1987
scissor, left Arthropedics, Inc. k873501 11/02/1987

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