FDA 510(k) Application Details - K983068

Device Classification Name	Device, Pasteurization, Hot Water   More FDA Info for this Device
510(K) Number	K983068
Device Name	Device, Pasteurization, Hot Water
Applicant	STERIS Corporation 5960 Heisley Road Mentor, OH 44060 US Other 510(k) Applications for this Company
Contact	RAYMOND URSICK Other 510(k) Applications for this Contact
Regulation Number	880.6991   More FDA Info for this Regulation Number
Classification Product Code	LDS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/02/1998
Decision Date	05/31/2000
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