FDA 510(k) Application Details - K140667

Device Classification Name	Catheter, Retention Type, Balloon   More FDA Info for this Device
510(K) Number	K140667
Device Name	Catheter, Retention Type, Balloon
Applicant	WELL LEAD MEDICAL CO. LTD C-4 JINHU INDUSTRIAL ESTATE HUALONG, PAN YU GUANGZHOU 511434 CN Other 510(k) Applications for this Company
Contact	HAN GUANG YUAN Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	EZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/18/2014
Decision Date	12/15/2014
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