FDA 510(k) Application Details - K182827

Device Classification Name	Sterilant, Medical Devices   More FDA Info for this Device
510(K) Number	K182827
Device Name	Sterilant, Medical Devices
Applicant	STERIS Corporation 5976 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	880.6885   More FDA Info for this Regulation Number
Classification Product Code	MED Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/05/2018
Decision Date	01/31/2019
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