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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 K171088
Device Name Cochlear Baha SoundArc
Applicant
Cochlear Americas
13059 E. Peakview Avenue
Centennial,  CO  80111
Applicant Contact Beth Murray
Correspondent
Cochlear Americas
13059 E. Peakview Avenue
Centennial,  CO  80111
Correspondent Contact Beth Murray
Regulation Number874.3302
Classification Product Code
LXB  
Date Received04/12/2017
Decision Date 06/07/2017
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
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