FDA 510(k) Application Details - K162188

Device Classification Name	More FDA Info for this Device
510(K) Number	K162188
Device Name	Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)
Applicant	VR MEDICAL TECHNOLOGY 90 GAOXIN ROAD, ZHOUZHANG KUNSHAN 215325 CN Other 510(k) Applications for this Company
Contact	LEE PAN 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	08/04/2016
Decision Date	09/22/2016
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