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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 K112688
Device Name ENSITE VELOCITY SYSTEM V.3.0
Original Applicant
ST. JUDE MEDICAL
one st. jude medical drive
st. paul,  MN  55117
Original Contact donna r lunak
Regulation Number870.1425
Classification Product Code
DQK  
Date Received09/15/2011
Decision Date 11/09/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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