FDA 510(k) Application Details - K143078

Device Classification Name Clamp, Vascular

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510(K) Number K143078
Device Name Clamp, Vascular
Applicant SYMMETRY SURGICAL
3034 OWEN DRIVE
ANTIOCH, TN 37013 US
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Contact Victoria Rogers
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 10/27/2014
Decision Date 05/14/2015
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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