FDA 510(k) Application Details - K980868

Device Classification Name	Colonic Irrigation System   More FDA Info for this Device
510(K) Number	K980868
Device Name	Colonic Irrigation System
Applicant	GENTLE COLONICS, INC. 3722 AVENUE SAUSALITO IRVINE, CA 92606-1849 US Other 510(k) Applications for this Company
Contact	KAREN U SALINAS 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	03/06/1998
Decision Date	08/06/1998
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