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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
510(k) Number K113667
Device Name CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING
Original Applicant
EDWARDS LIFESCIENCES, LLC.
12050 lone peak pkwy
draper,  UT  84020
Original Contact karen jones
Regulation Number870.4290
Classification Product Code
DTL  
Date Received12/13/2011
Decision Date 01/12/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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