FDA 510(k) Application Details - K010122

Device Classification Name	System, Irrigation, Urological   More FDA Info for this Device
510(K) Number	K010122
Device Name	System, Irrigation, Urological
Applicant	G.U.-TEK 904 OAK TREE AVE. SOUTH PLAINFIELD, NJ 07080 US Other 510(k) Applications for this Company
Contact	ANTHONY SOLAZZO 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	01/16/2001
Decision Date	06/04/2001
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