FDA 510(k) Application Details - K180800

Device Classification Name	Colonic Irrigation System   More FDA Info for this Device
510(K) Number	K180800
Device Name	Colonic Irrigation System
Applicant	Colonic Plus 73-925 Hwy 111, Ste. L Palm Desert, CA 92260 US Other 510(k) Applications for this Company
Contact	Rosa Alvarez 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	03/27/2018
Decision Date	06/01/2018
Decision	SESK - SUBST EQUIV - KIT
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