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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 K121767
Model 49260 AND 49261
Device Name CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE
Original Applicant
MEDTRONIC INC.
8200 coral sea street ne
mounds view,  MN  55112
Original Contact mary e donlin
Regulation Number878.4400
Classification Product Code
OCL  
Date Received06/15/2012
Decision Date 07/13/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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