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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name saline, vascular access flush
510(k) Number K153481
Device Name 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe
Applicant
BECTON, DICKINSON AND COMPANY
1 BECTON DRIVE
FRANKLIN LAKES,  NJ  07417
Applicant Contact John Blewitt
Correspondent
BECTON, DICKINSON AND COMPANY
1 BECTON DRIVE
FRANKLIN LAKES,  NJ  07417
Correspondent Contact John Blewitt
Regulation Number880.5200
Classification Product Code
NGT  
Date Received12/03/2015
Decision Date 04/04/2016
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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