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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Replacement, Ossicular Prosthesis, Total
510(k) Number K241269
Device Name mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit
Applicant
MED-EL Elektromedizinische Geräte GmbH
Fürstenweg 77a
Innsbruck,  AT 6020
Applicant Contact Inés Román Santiago
Correspondent
MED-EL Elektromedizinische Geräte GmbH
Fürstenweg 77a
Innsbruck,  AT 6020
Correspondent Contact Inés Román Santiago
Regulation Number874.3495
Classification Product Code
ETA  
Date Received04/24/2024
Decision Date 01/17/2025
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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