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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 K081606
Device Name BAHA INTENSO
Applicant
COCHLEAR AMERICAS
400 INVERNESS PARKWAY,
SUITE 400
ENGLEWOOD,  CO  80112
Applicant Contact SEAN BUNDY
Correspondent
COCHLEAR AMERICAS
400 INVERNESS PARKWAY,
SUITE 400
ENGLEWOOD,  CO  80112
Correspondent Contact SEAN BUNDY
Regulation Number874.3302
Classification Product Code
LXB  
Date Received06/06/2008
Decision Date 08/28/2008
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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