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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 K093679
Device Name ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP, GILLINOV-COSGROVE SECTION GUIDE MODEL VARIOUS LAA0
Applicant
AtriCure, Inc.
6217 Center Park Dr.
West Chester,  OH  45069
Applicant Contact JAMES LUCKY
Correspondent
AtriCure, Inc.
6217 Center Park Dr.
West Chester,  OH  45069
Correspondent Contact JAMES LUCKY
Regulation Number878.4300
Classification Product Code
FZP  
Date Received11/27/2009
Decision Date 06/10/2010
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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