FDA 510(k) Application Details - K190502

Device Classification Name	More FDA Info for this Device
510(K) Number	K190502
Device Name	ENFit Oral / Enteral Syringe
Applicant	Jiangsu Caina Medical Co., Ltd. No. 23, Huanxi Rd. Zhutang Town Jiangyin City 214425 CN Other 510(k) Applications for this Company
Contact	Xinyan Ruan 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	03/01/2019
Decision Date	08/06/2019
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