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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 K131107
Device Name ATRICLIP GILLINOV-COSGROVE LAA CLIP
Applicant
ATRICURE, INC.
6217 CENTRE PARK DRIVE
WEST CHESTER,  OH  45069
Applicant Contact REBECCA WALTERS
Correspondent
ATRICURE, INC.
6217 CENTRE PARK DRIVE
WEST CHESTER,  OH  45069
Correspondent Contact REBECCA WALTERS
Regulation Number878.4300
Classification Product Code
FZP  
Date Received04/19/2013
Decision Date 05/14/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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