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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 K191457
Device Name BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)
Applicant
Med-El Elektromedizinische Geraete GmbH
Fuestenweg 77a
Innsbruck,  AT 6020
Applicant Contact Ines Roman Santiago
Correspondent
Med-El Elektromedizinische Geraete GmbH
Fuestenweg 77a
Innsbruck,  AT 6020
Correspondent Contact Ines Roman Santiago
Regulation Number874.3340
Classification Product Code
PFO  
Date Received05/31/2019
Decision Date 09/18/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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