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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
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