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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 K101419
Device Name ENSITE VELOCITY SYSTEM, MODEL EE3000
Applicant
St Jude Medical
One St. Jude Medical Dr.
St. Paul,  MN  55117
Applicant Contact DONNA R LUNAK
Correspondent
St Jude Medical
One St. Jude Medical Dr.
St. Paul,  MN  55117
Correspondent Contact DONNA R LUNAK
Regulation Number870.1425
Classification Product Code
DQK  
Date Received05/20/2010
Decision Date 06/11/2010
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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