FDA 510(k) Application Details - K152082

Device Classification Name Clip, Implantable

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510(K) Number K152082
Device Name Clip, Implantable
Applicant Vesocclude Medical, LLC
7429 ACC BLVD
Suite 101
Raleigh, NC 27617 US
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Contact Freddy Cannady
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Regulation Number 878.4300

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Classification Product Code FZP
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Date Received 07/27/2015
Decision Date 02/26/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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