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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 K082467
Device Name ENSITE FUSION DYNAMIC REGISTRATION TOOL
Applicant
St Jude Medical
1350 Energy Ln., Suite 110
St. Paul,  MN  55108
Applicant Contact KAREN J MCKELVEY
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.1425
Classification Product Code
DQK  
Date Received08/27/2008
Decision Date 09/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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