FDA 510(k) Application Details - K132293

Device Classification Name Clamp, Vascular

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510(K) Number K132293
Device Name Clamp, Vascular
Applicant MARINE POLYMER TECHNOLOGIES
107 WATER STREET
DANVERS, MA 01923 US
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Contact SERGIO FINKIELSZTEIN
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 07/23/2013
Decision Date 07/31/2014
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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