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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K093203
Device Name CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM, MODELS 60831, 60832, 60841
Applicant
MEDTRONIC INC.
710 MEDTRONIC PARKWAY NE
MINNEAPOLIS,  MN  55432 -5604
Applicant Contact MARY E DONLIN
Correspondent
MEDTRONIC INC.
710 MEDTRONIC PARKWAY NE
MINNEAPOLIS,  MN  55432 -5604
Correspondent Contact MARY E DONLIN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/13/2009
Decision Date 02/26/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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