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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name port & catheter, implanted, subcutaneous, intravascular
510(K) Number K122767
Model H965450290 - II965450460
Device Name NMI PORT
Applicant
NAVILYST MEDICAL, INC.
26 forest street
marlborough,  MA  01752
Contact lorraine m hanley
Regulation Number880.5965
Classification Product Code
LJT  
Date Received09/10/2012
Decision Date 04/30/2013
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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