FDA 510(k) Application Details - K221068

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K221068
Device Name	Syringe, Piston
Applicant	Sichuan Prius Biotechnology Co., Ltd. No.2 Prius Road, Luo Long Industrial Park Nanxi District Yibin 644104 CN Other 510(k) Applications for this Company
Contact	Yan Liu 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	04/12/2022
Decision Date	10/04/2022
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