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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mouthguard, Prescription
510(k) Number K241729
Device Name Hard Splint & Thermo-Adaptive Splint
Applicant
Whip Mix Corporation
361 Farmington Ave.
Louisville,  KY  40209
Applicant Contact Meena Muniaswamy
Correspondent
Whip Mix Corporation
361 Farmington Ave.
Louisville,  KY  40209
Correspondent Contact Meena Muniaswamy
Classification Product Code
MQC  
Subsequent Product Code
KMY  
Date Received06/14/2024
Decision Date 03/18/2025
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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