FDA 510(k) Application Details - K000031

Device Classification Name	Colonic Irrigation System   More FDA Info for this Device
510(K) Number	K000031
Device Name	Colonic Irrigation System
Applicant	PRIME PACIFIC HEALTH INNOVATIONS CORPORATION 145 RIVERSIDE DR. NORTH VANCOUVER V7H 1T6 CA Other 510(k) Applications for this Company
Contact	OTHMAR VOGEL 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	01/05/2000
Decision Date	09/10/2001
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