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510(k) K231161

Device
0.9% Sodium Chloride Injection, USP BD PosiFlush? SF Saline Flush Syringe
Applicant
Becton, Dickinson and Company
510(k) number
K231161
Product code
NGT
Decision
Substantially Equivalent (SESE)
Decision date
2023-07-21
Date received
2023-04-24
Regulation
880.5200
Classification name
Saline, Vascular Access Flush
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Samhitha Mohan
Address
1 Becton Dr. Franklin Lakes NJ US 07417 07417

FDA Registration Numbers#

Source Documents#

510(k) summary PDF