FDA 510(k) Application Details - K050910

Device Classification Name	Electrode, Electrosurgical, Active, Urological   More FDA Info for this Device
510(K) Number	K050910
Device Name	Electrode, Electrosurgical, Active, Urological
Applicant	ROEI MEDICAL TECHNOLOGIES, LTD. 555 THIRTEENTH STREET, NW WASHINGTON, DC 20004 US Other 510(k) Applications for this Company
Contact	JONATHAN S KAHN Other 510(k) Applications for this Contact
Regulation Number	876.4300   More FDA Info for this Regulation Number
Classification Product Code	FAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/11/2005
Decision Date	06/16/2005
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