FDA 510(k) Application Details - K220083

Device Classification Name	More FDA Info for this Device
510(K) Number	K220083
Device Name	LDV((Low Dead Volume )Syringe
Applicant	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. No. 2 Guanyin Road, Taihu Economic Development Zone Anqing 246400 CN Other 510(k) Applications for this Company
Contact	Bingyi Xiang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QNQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/10/2022
Decision Date	05/25/2022
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