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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,therapeutic,long-term greater than 30 days
510(K) Number K122882
Model 45-897, 45-898, 45-941, 45-942, AND 45-943
Device Name NMI HPICC III
Applicant
NAVILYST MEDICAL, INC.
26 forest street
marlborough,  MA  01752
Contact wanda carpinella
Regulation Number880.5970
Classification Product Code
LJS  
Date Received09/20/2012
Decision Date 10/18/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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