FDA 510(k) Application Details - K972455

Device Classification Name	Colonic Irrigation System   More FDA Info for this Device
510(K) Number	K972455
Device Name	Colonic Irrigation System
Applicant	COLON THERAPEUTICS 6249 25TH ST. P.O. BOX 1401 GROVES, TX 77619 US Other 510(k) Applications for this Company
Contact	JIM J GIROUARD 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	07/01/1997
Decision Date	09/09/1997
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