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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, cryosurgical, accessories
510(k) Number K152337
Device Name cryoFORM cryoICE cryoablation probe
Applicant
ATRICURE, INC
6217 CENTRE PARK DR
WEST CHESTER,  OH  45069
Applicant Contact JONATHAN MCELWEE
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number878.4350
Classification Product Code
GEH  
Date Received08/19/2015
Decision Date 03/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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