FDA 510(k) Application Details - K963503

Device Classification Name Clamp, Vascular

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510(K) Number K963503
Device Name Clamp, Vascular
Applicant CARDIOTHORACIC SYSTEMS, INC.
10600 NORTH TANTAU AVE.
CUPERTINO, CA 95014 US
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Contact MICHAEL J BILLIG
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 09/03/1996
Decision Date 04/03/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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