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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 K201983
Device Name BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)
Applicant
Med-El Elektromedizinische Geraete GmbH
Fuerstenweg 77a
Innsbruck,  AT 6020
Applicant Contact Stephanie Haselwanter
Correspondent
Med-El Elektromedizinische Geraete GmbH
Fuerstenweg 77a
Innsbruck,  AT 6020
Correspondent Contact Stephanie Haselwanter
Regulation Number874.3340
Classification Product Code
PFO  
Date Received07/17/2020
Decision Date 10/09/2020
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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