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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 K161123
Device Name Baha 5 Power Sound Processor
Applicant
Cochlear Americas
13059 E. Peakview Avenue
Centennial,  CO  80111
Applicant Contact Laura Blair
Correspondent
Cochlear Americas
13059 E. Peakview Avenue
Centennial,  CO  80111
Correspondent Contact Laura Blair
Regulation Number874.3302
Classification Product Code
LXB  
Date Received04/21/2016
Decision Date 05/20/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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