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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 EAST PEAKVIEW AVENUE
CENTENNIAL,  CO  80111
Applicant Contact SEAN BUNDY
Correspondent
COCHLEAR AMERICAS
13059 EAST PEAKVIEW AVENUE
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
Recalls CDRH Recalls
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