FDA 510(k) Application Details - K223175

Device Classification Name	Stopcock, I.V. Set   More FDA Info for this Device
510(K) Number	K223175
Device Name	Stopcock, I.V. Set
Applicant	Baxter Healthcare Corporation 25212 West Illinois Route 120 Round Lake, IL 60073 US Other 510(k) Applications for this Company
Contact	Meaghan Bonn Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	FMG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/11/2022
Decision Date	03/10/2023
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