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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 K153245
Device Name Baha 5 Super Power Sound Processor
Applicant
Cochlear Americas
13059 E Peakview Ave.
Centennial,  CO  80111
Applicant Contact TRISTAN MANUS
Correspondent
Cochlear Americas
13059 E Peakview Ave.
Centennial,  CO  80111
Correspondent Contact TRISTAN MANUS
Regulation Number874.3302
Classification Product Code
LXB  
Date Received11/09/2015
Decision Date 03/02/2016
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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