510(k) K232485

AMSCO 600 Steam Sterilizer by Steris — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2023
Date Received
August 16, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Steam
Device Class
Class II
Regulation Number
880.6880
Review Panel
HO
Submission Type