FDA 510(k) Application Details - K964547

Device Classification Name Clamp, Vascular

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510(K) Number K964547
Device Name Clamp, Vascular
Applicant DEGANIA SILICONE, LTD.
DEGANIA BET
EMEK HAYARDEN 15130 IL
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Contact BETTE LUBIN
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 11/13/1996
Decision Date 01/08/1997
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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