FDA 510(k) Application Details - K162340

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K162340
Device Name	Tubes, Gastrointestinal (And Accessories)
Applicant	WELL LEAD MEDICAL CO., LTD C-4# JINHU INDUSTRIAL ESTATE HUALONG, PANYU GUANGZHOU 511434 CN Other 510(k) Applications for this Company
Contact	HUANG KAI GEN Other 510(k) Applications for this Contact
Regulation Number	876.5980   More FDA Info for this Regulation Number
Classification Product Code	KNT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/22/2016
Decision Date	10/11/2017
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