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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
510(k) Number K130521
Device Name ISOLATOR LINEAR PEN
Applicant
AtriCure, Inc.
6217 Centre Park Dr.
West Chester,  OH  45069
Applicant Contact REBECCA WALTERS
Correspondent
AtriCure, Inc.
6217 Centre Park Dr.
West Chester,  OH  45069
Correspondent Contact REBECCA WALTERS
Regulation Number878.4400
Classification Product Code
OCL  
Date Received02/28/2013
Decision Date 04/05/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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