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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, short-term less than 30 days
510(k) Number K161866
Device Name BioFlo Midline Catheter
Applicant
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH,  MA  07152
Applicant Contact ROBIN FULLER
Correspondent
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH,  MA  07152
Correspondent Contact ROBIN FULLER
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received07/07/2016
Decision Date 09/08/2016
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
Recalls CDRH Recalls
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