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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 K112072
Model ACM, CRYO1 AND CRYOICE
Device Name ATRICURE CRYO MODULE SYSTEM
Original Applicant
ATRICURE, INC.
6217 centre park drive
west chester,  OH  45069
Original Contact james l lucky
Regulation Number878.4350
Classification Product Code
GEH  
Date Received07/20/2011
Decision Date 08/03/2011
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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