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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 K121507
Models ACM, CRYO1, CRYO2
Device Name ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE)
Original Applicant
ATRICURE, INC.
6217 centre park drive
west chester,  OH  45069
Original Contact james lucky
Regulation Number878.4350
Classification Product Code
GEH  
Date Received05/21/2012
Decision Date 06/06/2012
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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