510(k) K210326

Bravo G4 Chamber Autoclave by Scican , Ltd. — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2021
Date Received
February 4, 2021
Clearance Type
Abbreviated
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