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510(k) K233026

Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer by Midmark Corporation — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2024
Date Received
September 22, 2023
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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