FDA 510(k) Application Details - K011208

Device Classification Name Clamp, Vascular

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510(K) Number K011208
Device Name Clamp, Vascular
Applicant BIOVER AG
252 W. RIDLEY AVE.
RIDLEY PARK, PA 19078 US
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Contact HEINZ E WICK
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 04/19/2001
Decision Date 10/02/2002
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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