FDA 510(k) Application Details - K152394

Device Classification Name	Indicator, Physical/Chemical Sterilization Process   More FDA Info for this Device
510(K) Number	K152394
Device Name	Indicator, Physical/Chemical Sterilization Process
Applicant	MEDIVATORS INC. 14605 28TH AVE NORTH MINNEAPOLIS, MN 55447 US Other 510(k) Applications for this Company
Contact	MEGAN DICKEY Other 510(k) Applications for this Contact
Regulation Number	880.2800   More FDA Info for this Regulation Number
Classification Product Code	JOJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/24/2015
Decision Date	03/11/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review