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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 K121089
Device Name NMI PICC III
Original Applicant
NAVILYST MEDICAL, INC.
26 forest street
marlborough,  MA  01752
Original Contact lorraine m hanley
Regulation Number880.5970
Classification Product Code
LJS  
Date Received04/10/2012
Decision Date 08/23/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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