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510(k) K201927

Getinge GSS610N Series Steam Sterilizer by Maquet GmbH — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2021
Date Received
July 10, 2020
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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