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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 K202048
Device Name Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App
Applicant
Cochlear Americas
10350 Park Meadows Drive
Lone Tree,  CO  80124
Applicant Contact Krystal Haley
Correspondent
Cochlear Americas
10350 Park Meadows Drive
Lone Tree,  CO  80124
Correspondent Contact Krystal Haley
Regulation Number874.3302
Classification Product Code
LXB  
Date Received07/24/2020
Decision Date 02/23/2021
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
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