FDA 510(k) Application Details - K033149

Device Classification Name	Colonic Irrigation System   More FDA Info for this Device
510(K) Number	K033149
Device Name	Colonic Irrigation System
Applicant	ULTIMATE CONCEPTS, INC. 3722 AVE. SAUSALITO IRVINE, CA 92606 US Other 510(k) Applications for this Company
Contact	GRACE HOLLAND Other 510(k) Applications for this Contact
Regulation Number	876.5220   More FDA Info for this Regulation Number
Classification Product Code	KPL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2003
Decision Date	03/23/2004
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