FDA 510(k) Application Details - K112662

Device Classification Name Clamp, Vascular

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510(K) Number K112662
Device Name Clamp, Vascular
Applicant MEDTRONIC XOMED, INC.
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE, FL 32216 US
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Contact MARSHA SEETARAM
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 09/13/2011
Decision Date 01/20/2012
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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