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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name apparatus, autotransfusion
510(k) Number K112245
Device Name XTRA
Original Applicant
SORIN GROUP ITALIA S.R.L
parexel consulting
195 west street
waltham,  MA  02451
Original Contact barry sall
Regulation Number868.5830
Classification Product Code
CAC  
Date Received08/04/2011
Decision Date 09/06/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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