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510(k) K233844

OdneClean by Odne AG — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2024
Date Received
December 4, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scaler, Ultrasonic
Device Class
Class II
Regulation Number
872.4850
Review Panel
DE
Submission Type

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