FDA 510(k) Application Details - K191639

Device Classification Name	Syringe, Antistick   More FDA Info for this Device
510(K) Number	K191639
Device Name	Syringe, Antistick
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	Bai Baodong Other 510(k) Applications for this Contact
Regulation Number	880.5860   More FDA Info for this Regulation Number
Classification Product Code	MEG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/19/2019
Decision Date	09/11/2020
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