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510(k) K231663

The AVEOtsd (Tongue Stabilizing Device) Mouthpiece by Innovative Health Technologies (Nz), Ltd. — Product Code LRK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2023
Date Received
June 7, 2023
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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