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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name oxygenator, cardiopulmonary bypass
510(k) Number K122254
Device Name INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
Original Applicant
SORIN GROUP ITALIA S.R.L.
14401 w. 65th way
arvada,  CO  80004
Original Contact scott light
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received07/27/2012
Decision Date 08/24/2012
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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