FDA 510(k) Application Details - K161979

Device Classification Name	More FDA Info for this Device
510(K) Number	K161979
Device Name	ENFit enteral syringe
Applicant	JIANGYIN CAINA TECHNOLOGY CO., LTD. NO.2, TAIFU ROAD, HUASHI TOWN JIANGYIN 214421 CN Other 510(k) Applications for this Company
Contact	JUN LU 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	07/18/2016
Decision Date	03/22/2017
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