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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name surgical device, for ablation of cardiac tissue
510(k) Number K122611
Model MCRI
Device Name COOLRAIL LINEAR PEN MODEL MCRI
Original Applicant
ATRICURE, INC.
6217 centre park drive
west chester,  OH  45069
Original Contact jim lucky, rac
Regulation Number878.4400
Classification Product Code
OCL  
Date Received08/28/2012
Decision Date 09/26/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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