FDA 510(k) Application Details - K222772

Device Classification Name	More FDA Info for this Device
510(K) Number	K222772
Device Name	Oral/Enteral Syringe with ENFit connector
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	PNR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/14/2022
Decision Date	08/17/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review