FDA 510(k) Application Details - K223476

Device Classification Name	Sterilizer, Chemical   More FDA Info for this Device
510(K) Number	K223476
Device Name	Sterilizer, Chemical
Applicant	Steris Corporation 5960 Heisley Rd Mentor, OH 44060 US Other 510(k) Applications for this Company
Contact	Anthony Piotrkowski Other 510(k) Applications for this Contact
Regulation Number	880.6860   More FDA Info for this Regulation Number
Classification Product Code	MLR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/18/2022
Decision Date	08/07/2023
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