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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, diagnostic
510(K) Number K113638
Device Name NMI 2.8 MICROCATHETER
Applicant
NAVILYST MEDICAL, INC.
26 forest street
marlborough,  MA  01752
Contact wanda carpinella
Regulation Number870.1200
Classification Product Code
DQO  
Date Received12/09/2011
Decision Date 01/05/2012
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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