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510(k) K230532

RADx Intraoral Appliance for Snoring and Sleep Apnea by Achaemenid, LLC — Product Code LQZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2023
Date Received
February 27, 2023
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Jaw Repositioning
Device Class
Class II
Regulation Number
872.5570
Review Panel
DE
Submission Type

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