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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
510(k) Number K211640
Device Name Ponto 5 Mini
Applicant
Oticon Medical AB
Datavagen 37b
Askim,  SE SE-436 32
Applicant Contact Anja Ravn
Correspondent
Oticon Medical AB
Datavagen 37b
Askim,  SE SE-436 32
Correspondent Contact Anja Ravn
Regulation Number874.3302
Classification Product Code
LXB  
Subsequent Product Code
MAH  
Date Received05/27/2021
Decision Date 08/10/2021
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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