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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 K122811
Device Name CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE
Applicant
MEDTRONIC INC.
7611 northland drive
minneapolis,  MN  55428
Contact jacqueline a hauge
Regulation Number870.4290
Classification Product Code
DTL  
Date Received09/13/2012
Decision Date 10/12/2012
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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