FDA 510(k) Application Details - K150381

Device Classification Name	Colonic Irrigation System   More FDA Info for this Device
510(K) Number	K150381
Device Name	Colonic Irrigation System
Applicant	QUALITY MEDICAL SUPPLY, INC 13174 W. FOXFIRE DRIVE, SUITE B132 SURPRISE, AZ 85378 US Other 510(k) Applications for this Company
Contact	JULIE SOLOMON 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	02/18/2015
Decision Date	09/11/2015
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