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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Active Implantable Bone Conduction Hearing System
510(k) Number K240614
Device Name Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS
Applicant
Oticon Medical AB
Datavagen 37 B
Askim,  SE 436 32
Applicant Contact Pernilla Gustafsson
Correspondent
Oticon Medical AB
Datavagen 37 B
Askim,  SE 436 32
Correspondent Contact Pernilla Gustafsson
Regulation Number874.3340
Classification Product Code
PFO  
Date Received03/05/2024
Decision Date 07/10/2024
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
Predetermined Change
Control Plan Authorized		 No
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