FDA 510(k) Application Details - K071057

Device Classification Name	Colonic Irrigation System   More FDA Info for this Device
510(K) Number	K071057
Device Name	Colonic Irrigation System
Applicant	TILLER MIND BODY, INC. 42 EAST WHISTERS BEND CIRCLE THE WOODLANDS, TX 77384 US Other 510(k) Applications for this Company
Contact	HAROLD L JONES 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	04/16/2007
Decision Date	10/05/2007
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