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510(k) K230548

Myoaligner Appliance by Myohealth Technologies, LLC — Product Code MQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 2024
Date Received
February 28, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mouthguard, Prescription
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

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