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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 Dr.
Franklin Lakes,  NJ  07045
Applicant Contact John Blewitt
Correspondent
Becton, Dickinson and Company
1 Becton Dr.
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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