FDA 510(k) Application Details - K192020

Device Classification Name	Indicator, Physical/Chemical Sterilization Process   More FDA Info for this Device
510(K) Number	K192020
Device Name	Indicator, Physical/Chemical Sterilization Process
Applicant	STERIS Corporation 5960 Heisley Road Mentor, OH 44077 US Other 510(k) Applications for this Company
Contact	Gregory Land 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	07/29/2019
Decision Date	09/05/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review