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510(k) K250353

Oniris; Oniris Plus by Oniris — Product Code LRK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2025
Date Received
February 7, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Anti-Snoring
Device Class
Class II
Regulation Number
872.5570
Review Panel
DE
Submission Type

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