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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 K082279
Device Name EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2
Applicant
St Jude Medical
240 Santa Ana Court
Sunnyvale,  CA  94085
Applicant Contact DONNA R LUNAK
Correspondent
St Jude Medical
240 Santa Ana Court
Sunnyvale,  CA  94085
Correspondent Contact DONNA R LUNAK
Regulation Number878.4400
Classification Product Code
OCL  
Date Received08/11/2008
Decision Date 09/16/2008
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
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