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510(k) K230495

Serena Sleep Night Guard by Meris Investment Group — Product Code MQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2023
Date Received
February 23, 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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