FDA 510(k) Application Details - K141685

Device Classification Name Clamp, Vascular

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510(K) Number K141685
Device Name Clamp, Vascular
Applicant COMBAT MEDICAL SYSTEMS, LLC
400 N. WASHINGTON STREET, SUITE 100
ALEXANDRIA, VA 22314 US
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Contact Calley Herzog
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 06/23/2014
Decision Date 01/26/2015
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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