FDA 510(k) Application Details - K211728

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K211728
Device Name	Syringe, Piston
Applicant	Jiangsu Kangyou Medical Instrument Co., Ltd. Tangzhuang Yaotang Town Jintan 213223 CN Other 510(k) Applications for this Company
Contact	Xiang Yao 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	06/04/2021
Decision Date	10/05/2021
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