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FDA 510(k) Application Details - K122811
Device Classification Name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
More FDA Info for this Device
510(K) Number
K122811
Device Name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Applicant
MEDTRONIC INC.
7611 NORTHLAND DRIVE
MINNEAPOLIS, MN 55428 US
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Contact
JACQUELINE A HAUGE
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Regulation Number
870.4290
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Classification Product Code
DTL
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More FDA Info for this Product Code
Date Received
09/13/2012
Decision Date
10/12/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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