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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 K131038
Device Name NMI PICC MAXIMAL BARRIER NURSING KITS
Applicant
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH,  MA  01752
Applicant Contact MARION W GORDON
Correspondent
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH,  MA  01752
Correspondent Contact MARION W GORDON
Regulation Number880.5970
Classification Product Code
LJS  
Date Received04/15/2013
Decision Date 05/09/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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