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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 Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
510(k) Number K121767
Device Name CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE
Applicant
MEDTRONIC INC.
8200 Coral Sea Street NE
Mounds View,  MN  55112
Applicant Contact MARY E DONLIN
Correspondent
MEDTRONIC INC.
8200 Coral Sea Street NE
Mounds View,  MN  55112
Correspondent Contact MARY E DONLIN
Regulation Number878.4400
Classification Product Code
OCL  
Date Received06/15/2012
Decision Date 07/13/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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