FDA 510(k) Application Details - K153392

Device Classification Name	More FDA Info for this Device
510(K) Number	K153392
Device Name	STERIZONE VP4 Sterilizer
Applicant	TS03 INC 2505, AVENUE DALTON QUEBEC G1P 3S5 CA Other 510(k) Applications for this Company
Contact	Nathalie Racette Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PJJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/24/2015
Decision Date	03/24/2016
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