FDA 510(k) Application Details - K123571

Device Classification Name Clamp, Vascular

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510(K) Number K123571
Device Name Clamp, Vascular
Applicant CARDIOMEDICAL GMBH
AMSTEL 320-1
AMSTERDAM, NOORD-HOLLAND 1017AP NL
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Contact ANGELIKA SCHERP
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 11/20/2012
Decision Date 08/01/2013
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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