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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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creatinine reagent Derma Media Lab., Inc. k955938 03/12/1996
aurora imaging system Advanced Mammography Systems, Inc. k950837 02/26/1996
nova chemistry performance check solution Nova Biomedical Corp. k955260 02/02/1996
ultrack total knee system Wrightmedicaltechnologyinc k953439 01/30/1996
bard expanded ptfe vascular graft(modification) C.R. Bard, Inc. k954582 12/07/1995
suction tip cleaner cup Moore/Gobel k952219 11/15/1995
ath full profile acetabular cup system Kinamed, Inc. k954213 10/25/1995
eml105 electrolyte metabolite analyzer Radiometer America, Inc. k952621 10/17/1995
integral vii 3.25mm biointegrated dental implant system Calcitek, Inc. k946311 10/04/1995
unicor, inc. connectors & airway extensions Unicor, Inc. k953786 09/19/1995

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