FDA 510(k) Application Details - K123041

Device Classification Name Clamp, Vascular

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510(K) Number K123041
Device Name Clamp, Vascular
Applicant FORGE MEDICAL INC.
150 LEVINBERG LANE
WAYNE, NJ 07470 US
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Contact MASON DIAMOND
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 09/28/2012
Decision Date 05/29/2013
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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