FDA 510(k) Application Details - K200557

Device Classification Name	More FDA Info for this Device
510(K) Number	K200557
Device Name	Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)
Applicant	Jiangsu Shenli Medical Production Co., Ltd No. 20, Changzheng Road, Zhenglu Changzhou City 213111 CN Other 510(k) Applications for this Company
Contact	Tina Cai 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	03/03/2020
Decision Date	09/28/2020
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