FDA 510(k) Application Details - K151084

Device Classification Name	Endoscopic Access Overtube, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K151084
Device Name	Endoscopic Access Overtube, Gastroenterology-Urology
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	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FED Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/2015
Decision Date	01/07/2016
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