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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name introducer, catheter
510(k) Number K111092
Device Name ENGAGE/ENGAGE TR INTRODUCERS
Original Applicant
ST. JUDE MEDICAL
14901 deveau pl.
minnetonka,  MN  55345 -2126
Original Contact venkata damaraju
Regulation Number870.1340
Classification Product Code
DYB  
Date Received04/19/2011
Decision Date 06/09/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
statement statement
Type Special
Reviewed by Third Party No
Combination Product No
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