FDA 510(k) Application Details - K212764

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K212764
Device Name	Syringe, Piston
Applicant	Medwell Technology Ltd 8th Building, Pujing, Fumin Industry Zone, DaLang Town Dongguan City 523770 CN Other 510(k) Applications for this Company
Contact	Andy Song Other 510(k) Applications for this Contact
Regulation Number	880.5860   More FDA Info for this Regulation Number
Classification Product Code	FMF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/31/2021
Decision Date	11/04/2022
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