FDA 510(k) Application Details - K062551

Device Classification Name	System, Irrigation, Urological   More FDA Info for this Device
510(K) Number	K062551
Device Name	System, Irrigation, Urological
Applicant	NEXUS MEDICAL, LLC 11315 STRANG LINE ROAD LENEXA, KS 66215 US Other 510(k) Applications for this Company
Contact	ANITA SMITH Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LJH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/30/2006
Decision Date	12/15/2006
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