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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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endotrak system Instratek, Inc. k925083 04/27/1993
thyroglobulin autoantibody immunoassay kit Nichols Institute k930777 04/08/1993
graspers & scissors (minimal access surg instr) Conmedcorp k924469 04/07/1993
bcd advanced blood carioplegia systems Sorin Biomedica, Fiat, USA, Inc. k925369 03/26/1993
merocel epistacis kit Merocel Corp. k920394 03/18/1993
unifit femoral stem Osteo Technology, Inc. k922871 02/12/1993
cholangiography catheter Applied Medical Resources k924128 02/10/1993
.016' x .016 nickel titanium uprighting spring Ultimate Wireforms, Inc. k923836 12/23/1992
sensor gui Hospitronic k923519 12/08/1992
nova 12 analyzer, modification Nova Biomedical Corp. k924743 11/06/1992

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