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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 K131240
Device Name COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT
Applicant
Cochlear Americas
13059 E Peakview Ave.
Centennial,  CO  80111
Applicant Contact SEAN BUNDY
Correspondent
Cochlear Americas
13059 E Peakview Ave.
Centennial,  CO  80111
Correspondent Contact SEAN BUNDY
Regulation Number874.3302
Classification Product Code
LXB  
Date Received05/01/2013
Decision Date 11/07/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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