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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clip, Implantable
510(k) Number K152082
FOIA Releasable 510(k) K152082
Device Name Vesocclude Polymer Ligating Clip
Applicant
Vesocclude Medical, LLC
7429 ACC BLVD
Suite 101
Raleigh,  NC  27617
Applicant Contact Freddy Cannady
Correspondent
Vesocclude Medical, LLC
7429 ACC BLVD
Suite 101
Raleigh,  NC  27617
Correspondent Contact Freddy Cannady
Regulation Number878.4300
Classification Product Code
FZP  
Date Received07/27/2015
Decision Date 02/26/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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