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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 K212136
Device Name Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App
Applicant
Cochlear Americas
10350 Park Meadows Dr.
Centennial,  CO  80124
Applicant Contact Whitney Alexander
Correspondent
Cochlear Americas
10350 Park Meadows Dr.
Centennial,  CO  80124
Correspondent Contact Whitney Alexander
Regulation Number874.3302
Classification Product Code
LXB  
Date Received07/08/2021
Decision Date 09/29/2021
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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