FDA 510(k) Application Details - K102025

Device Classification Name Clamp, Vascular

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510(K) Number K102025
Device Name Clamp, Vascular
Applicant COMBAT MEDICAL SYSTEMS, LLC
13417 QUIVAS ST
WESTMINSTER, CO 80234 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 07/19/2010
Decision Date 08/11/2010
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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