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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K051840
Device Name ENSITE VERISMO SOFTWARE
Applicant
St Jude Medical
1350 Energy Lane. Suite 110
St. Paul,  MN  55108
Applicant Contact KAREN MCKELVEY
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK J0B
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/07/2005
Decision Date 08/15/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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