FDA 510(k) Application Details - K190260

Device Classification Name	More FDA Info for this Device
510(K) Number	K190260
Device Name	STERIZONE(R) VP4 Sterilizer
Applicant	TSO3 Inc 2505 Avenue Dalton Quebec G1P 3S5 CA Other 510(k) Applications for this Company
Contact	Sandy Cliche 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	02/08/2019
Decision Date	07/19/2019
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