510(k) K222608

Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS by Tuttnauer , Ltd. — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2022
Date Received
August 29, 2022
Clearance Type
Traditional
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