FDA 510(k) Application Details - K233065

Device Classification Name	Sterilizer, Chemical   More FDA Info for this Device
510(K) Number	K233065
Device Name	Sterilizer, Chemical
Applicant	Steris 5960 Heisley Road Mentor, MA 44060 US Other 510(k) Applications for this Company
Contact	Jennifer Nalepka 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	09/26/2023
Decision Date	10/20/2023
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