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510(k) K214120

GSS610N21 Series Steam Sterilizer by Maquet GmbH — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2022
Date Received
December 30, 2021
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

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