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510(k) K243516

Remi Custom Night Guard by Grindguard, Inc. — Product Code MQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2025
Date Received
November 13, 2024
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

Other clearances by Grindguard, Inc.

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