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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 K161552
Device Name 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe
Applicant
Becton Dickinson and Company
1 Becton Drive
Franklin Lakes,  NJ  07045
Applicant Contact John Blewitt
Correspondent
Becton Dickinson and Company
1 Becton Drive
Franklin Lakes,  NJ  07045
Correspondent Contact John Blewitt
Regulation Number880.5200
Classification Product Code
NGT  
Date Received06/06/2016
Decision Date 02/02/2017
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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