FDA 510(k) Application Details - K222385

Device Classification Name	More FDA Info for this Device
510(K) Number	K222385
Device Name	Bifurcated Needle
Applicant	Anhui Tiankang Medical Technology Co., Ltd. No.228,Weiyi Road, Economic Development Zone Tianchang 239300 CN Other 510(k) Applications for this Company
Contact	Zhang Yong Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SCL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/08/2022
Decision Date	12/06/2022
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