FDA 510(k) Application Details - K202319

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K202319
Device Name	Needle, Hypodermic, Single Lumen
Applicant	Tianjin Huahong Technology Co., Ltd. A01, Plant B, No. 278, Hangkong Road, Tianjin Pilot Free Trade Zone Tianjin 300308 CN Other 510(k) Applications for this Company
Contact	Yan Li 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	08/17/2020
Decision Date	11/12/2021
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