FDA 510(k) Application Details - K180236

Device Classification Name	Tube, Feeding   More FDA Info for this Device
510(K) Number	K180236
Device Name	Tube, Feeding
Applicant	VR MEDICAL TECHNOLOGY CO., LTD No. 90 Gaoxin Rd. Zhouzhuang 215325 CN Other 510(k) Applications for this Company
Contact	Lee Pan Other 510(k) Applications for this Contact
Regulation Number	876.5980   More FDA Info for this Regulation Number
Classification Product Code	FPD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/29/2018
Decision Date	01/18/2019
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