FDA 510(k) Application Details - K140562

Device Classification Name	Accessories, Catheter, G-U   More FDA Info for this Device
510(K) Number	K140562
Device Name	Accessories, Catheter, G-U
Applicant	LEOMED, LLC 9001 AIRPORT BLVD SUITE 503 HOUSTON, TX 77061 US Other 510(k) Applications for this Company
Contact	BANDULA WIJAY Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	KNY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/05/2014
Decision Date	06/16/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review