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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 K172460
Device Name ADHEAR System
Applicant
MED-EL Elektromedizinische Geraete GmbH
Fuerstenweg 77a
Innsbruck,  AT 6020
Applicant Contact Elizabeth Gfoeller
Correspondent
Med-EL Elektromedizinische Geraete GmbH
Fuerstenweg 77a
Innsbruck,  AT 6020
Correspondent Contact Elizabeth Gfoeller
Regulation Number874.3302
Classification Product Code
LXB  
Date Received08/14/2017
Decision Date 04/27/2018
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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