FDA 510(k) Application Details - K162027

Device Classification Name Clamp, Vascular

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510(K) Number K162027
Device Name Clamp, Vascular
Applicant MEDTRONIC VASCULAR
37A CHERRY HILL DRIVE
DANVERS, MA 01923 US
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Contact COLLEEN MULLINS
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 07/22/2016
Decision Date 10/21/2016
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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