510(k) K983947

AMERSE 2 by STERIS Corporation — Product Code LRJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1998
Date Received
November 5, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Disinfectant, Medical Devices
Device Class
Class I
Regulation Number
880.6890
Review Panel
HO
Submission Type