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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 K190151
Device Name COBRA Fusion Ablation System
Applicant
AtriCure, Inc.
7555 Innovation Way
Mason,  OH  45040
Applicant Contact Melissa Smallwood
Correspondent
AtriCure, Inc.
7555 Innovation Way
Mason,  OH  45040
Correspondent Contact Melissa Smallwood
Regulation Number878.4400
Classification Product Code
OCL  
Date Received01/30/2019
Decision Date 02/25/2019
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
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