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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 K193162
Device Name EPi-Sense Guided Coagulation System with VisiTrax
Applicant
AtriCure, Inc.
7555 Innovation Way
Mason,  OH  45040
Applicant Contact Caitlin Wunderlin
Correspondent
AtriCure, Inc.
7555 Innovation Way
Mason,  OH  45040
Correspondent Contact Caitlin Wunderlin
Regulation Number878.4400
Classification Product Code
OCL  
Date Received11/15/2019
Decision Date 12/13/2019
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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