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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 K080292
Device Name EPICOR ABLATION SYSTEM
Applicant
St Jude Medical
1350 Energy Ln., Suite 110
St. Paul,  MN  55108
Applicant Contact KAREN J MCKELVEY
Correspondent
St Jude Medical
1350 Energy Ln., Suite 110
St. Paul,  MN  55108
Correspondent Contact KAREN J MCKELVEY
Regulation Number878.4400
Classification Product Code
OCL  
Date Received02/04/2008
Decision Date 07/25/2008
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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