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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K060954
Device Name MODIFICATION TO ENSITE SYSTEM, MODEL EE3000
Applicant
St. Jude Medical, Inc.-Endocardial Solutions
1350 Energy Ln., Suite 110
St. Paul,  MN  55108 -5254
Applicant Contact KAREN J MCKELVEY
Correspondent
St. Jude Medical, Inc.-Endocardial Solutions
1350 Energy Ln., Suite 110
St. Paul,  MN  55108 -5254
Correspondent Contact KAREN J MCKELVEY
Regulation Number870.1425
Classification Product Code
DQK  
Date Received04/07/2006
Decision Date 04/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
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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