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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 K140058
Device Name ATRICURE CRYO MODULE SYSTEM
Applicant
ATRICURE, INC.
6217 CENTRE PARK DRIVE
WEST CHESTER,  OH  45069
Applicant Contact KARL DAHLQUIST
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 Received01/10/2014
Decision Date 01/24/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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