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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 K150407
FOIA Releasable 510(k) K150407
Device Name BioFlo Midline Catheter
Applicant
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH,  MA  01752
Applicant Contact Brandon M Brackett
Correspondent
NAVILYST MEDICAL, INC.
26 FOREST STREET
MARLBOROUGH,  MA  01752
Correspondent Contact Brandon M Brackett
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received02/18/2015
Decision Date 05/15/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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