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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, Implanted
510(k) Number K150555
Device Name BA400 14mm Abutment
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
MAH  
Date Received03/04/2015
Decision Date 07/15/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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