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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Partial Ossicular Replacement
510(k) Number K241261
Device Name mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial 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 Number874.3450
Classification Product Code
ETB  
Date Received04/26/2024
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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