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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hearing Aid, Bone Conduction, Implanted
510(k) Number K261142
Device Name Ponto 5 Mini; Ponto 5 Superpower
Applicant
Oticon Medical AB
Datavägen 37 B
Askim,  SE 43632
Applicant Contact Anders Johansson
Correspondent
Oticon Medical AB
Datavägen 37 B
Askim,  SE 43632
Correspondent Contact Anders Johansson
Regulation Number874.3302
Classification Product Code
MAH  
Subsequent Product Code
LXB  
Date Received04/07/2026
Decision Date 08/26/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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