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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Surgical, Cryogenic
510(k) Number K142203
Device Name Atricure Cryo Module System; cryoICE cryoablation probe
Applicant
AtriCure, Inc.
6217 Centre Park Dr.
West Chester,  OH  45069
Applicant Contact Jonathan McElwee
Correspondent
AtriCure, Inc.
6217 Centre Park Dr.
West Chester,  OH  45069
Correspondent Contact Jonathan McElwee
Regulation Number882.4250
Classification Product Code
GXH  
Date Received08/11/2014
Decision Date 11/25/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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