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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 K190540
Device Name Ponto 4
Applicant
Oticon Medical AB
Datavagen 37 B
Askim,  SE SE-436 32
Applicant Contact Lise Terkelsen
Correspondent
Oticon Medical AB
Datavagen 37 B
Askim,  SE SE-436 32
Correspondent Contact Lise Terkelsen
Regulation Number874.3302
Classification Product Code
LXB  
Subsequent Product Codes
ESD   MAH  
Date Received03/04/2019
Decision Date 05/02/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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