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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 K131553
Device Name XTRA
Original Applicant
SORIN GROUP DEUTSCHLAND GMBH
195 west street
waltham,  MA  02451
Original Contact barry sall, rac, fraps
Regulation Number868.5830
Classification Product Code
CAC  
Date Received05/30/2013
Decision Date 03/21/2014
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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