FDA 510(k) Application Details - DEN230085

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN230085
Device Name	VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator
Applicant	STERIS 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	More FDA Info for this Regulation Number
Classification Product Code	SDC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/18/2023
Decision Date	11/12/2024
Decision	DENG -
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review