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510(k) K241729

Hard Splint & Thermo-Adaptive Splint by Whip Mix Corporation — Product Code MQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2025
Date Received
June 14, 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

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