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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 K211311
Device Name AtriCure Isolator® Synergy™ Surgical Ablation System
Applicant
AtriCure, Inc.
7555 Innovation Way
West Chester,  OH  45040
Applicant Contact Jon McElwee
Correspondent
AtriCure, Inc.
7555 Innovation Way
West Chester,  OH  45040
Correspondent Contact Jon McElwee
Regulation Number878.4400
Classification Product Code
OCL  
Date Received04/30/2021
Decision Date 05/28/2021
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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