FDA 510(k) Application Details - K981956

Device Classification Name Clamp, Vascular

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510(K) Number K981956
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 06/04/1998
Decision Date 07/09/1998
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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