FDA 510(k) Application Details - K223499

Device Classification Name	Stopcock, I.V. Set   More FDA Info for this Device
510(K) Number	K223499
Device Name	Stopcock, I.V. Set
Applicant	M/s Romsons International Unit-II, 9, Noida Special Economic Zone, Noida Dadri Road, Phase - II Noida, Gautam Buddha N Noida 201305 IN Other 510(k) Applications for this Company
Contact	Kishore Narian Khanna 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	11/21/2022
Decision Date	07/21/2023
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