FDA 510(k) Application Details - K203223

Device Classification Name	Accessories, Germicide, Cleaning, For Endoscopes   More FDA Info for this Device
510(K) Number	K203223
Device Name	Accessories, Germicide, Cleaning, For Endoscopes
Applicant	STERIS 5960 Heisley Rd Mentor, OH 44060 US Other 510(k) Applications for this Company
Contact	Marcia L. Benedict Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	NZA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/02/2020
Decision Date	01/28/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review