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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Anti-Snoring
510(k) Number K252531
Device Name Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)
Applicant
Myofunctional Research Co.
44 Signato Dr.
Helnsvale,  AU 4212
Applicant Contact Vikas Kundu
Correspondent
Dba the Eyedeas Company
21581 Midcrest Dr.
Lake Forest,  CA  92630
Correspondent Contact Colette Cozean
Regulation Number872.5570
Classification Product Code
LRK  
Date Received08/12/2025
Decision Date 03/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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