FDA 510(k) Application Details - K962510

Device Classification Name Clamp, Vascular

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510(K) Number K962510
Device Name Clamp, Vascular
Applicant HEARTPORT, INC.
200 CHESAPEAKE DR.
REDWOOD CITY, CA 94063 US
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Contact ROBERT J CHIN
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 06/27/1996
Decision Date 09/11/1996
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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