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510(k) K252307

Getinge GSS67N Series Steam Sterilizer by Maquet GmbH (A Getinge Group Company) — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2026
Date Received
July 24, 2025
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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