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510(k) K161552

0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe by Becton, Dickinson and Company — Product Code NGT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 2017
Date Received
June 6, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Saline, Vascular Access Flush
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.

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