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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 K121990
Device Name PICC CONVENIENCE KIT
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 Received07/06/2012
Decision Date 08/03/2012
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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