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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 K121909
Device Name INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVIOR
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  
Subsequent Product Code
DTN  
Date Received06/29/2012
Decision Date 07/26/2012
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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