FDA 510(k) Application Details - K192464

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K192464
Device Name	Needle, Hypodermic, Single Lumen
Applicant	Gangan Medical Technology Jiangsu Co., Ltd. 1st-4th Flr, Building G130, Fifth Phase of Standard Workshop Medical City Taizhou City 225300 CN Other 510(k) Applications for this Company
Contact	Wu Shuhui Other 510(k) Applications for this Contact
Regulation Number	880.5570   More FDA Info for this Regulation Number
Classification Product Code	FMI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/09/2019
Decision Date	08/25/2020
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