FDA 510(k) Application Details - K213955

Device Classification Name	More FDA Info for this Device
510(K) Number	K213955
Device Name	0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub
Applicant	Becton, Dickinson and Company 1 Becton Drive Franklin Lakes, NJ 07417 US Other 510(k) Applications for this Company
Contact	Samhitha Mohan Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QTI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/17/2021
Decision Date	07/16/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review