FDA 510(k) Application Details - K123194

Device Classification Name Clamp, Vascular

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510(K) Number K123194
Device Name Clamp, Vascular
Applicant NORTH AMERICAN RESCUE PRODUCTS, INC.
35 TEDWALL COURT
GREER, SC 29650-4791 US
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Contact WILLIAM SLEVIN
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 10/11/2012
Decision Date 01/03/2013
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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