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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 K153500
Device Name AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip
Applicant
AtriCure, Inc.
6217 Centre Park Dr.
West Chester,  OH  45069
Applicant Contact Jonathan McElwee
Correspondent
AtriCure, Inc.
6217 Centre Park Dr.
West Chester,  OH  45069
Correspondent Contact Jonathan McElwee
Regulation Number878.4300
Classification Product Code
FZP  
Date Received12/07/2015
Decision Date 01/27/2016
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
Predetermined Change
Control Plan Authorized		 No
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