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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 K091634
Device Name NMI FC
Original Applicant
NAVILYST MEDICAL, INC.
26 forest street
marlborough,  MA  01752
Original Contact shilpa prem
Regulation Number870.4290
Classification Product Code
DTL  
Date Received06/04/2009
Decision Date 03/01/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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