FDA 510(k) Application Details - K133724

Device Classification Name	Disinfectant, Subsystem, Water Purification   More FDA Info for this Device
510(K) Number	K133724
Device Name	Disinfectant, Subsystem, Water Purification
Applicant	MEDIVATORS, INC. 14605 28TH AVE. NORTH MINNEAPOLIS, MN 55447 US Other 510(k) Applications for this Company
Contact	KINNARI SHAH Other 510(k) Applications for this Contact
Regulation Number	876.5665   More FDA Info for this Regulation Number
Classification Product Code	NIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/06/2013
Decision Date	08/27/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review