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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 K120857
Model CDK-1411; CDK-1412; CDK-1413
Device Name EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX
Original Applicant
NCONTACT SURGICAL, INC.
1001 aviation parkway
ste 400
morrisville,  NC  27560
Original Contact jane ricupero
Regulation Number878.4400
Classification Product Code
OCL  
Date Received03/21/2012
Decision Date 11/13/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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