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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 K080363
Device Name BAHA CORDELLE II
Applicant
COCHLEAR BONE ANCHORED SYSTEMS AB
400 INVERNESS PARKWAY
SUITE 400
ENGLEWOOD,  CO  80112
Applicant Contact SEAN BUNDY
Correspondent
COCHLEAR BONE ANCHORED SYSTEMS AB
400 INVERNESS PARKWAY
SUITE 400
ENGLEWOOD,  CO  80112
Correspondent Contact SEAN BUNDY
Regulation Number874.3302
Classification Product Code
MAH  
Date Received02/11/2008
Decision Date 04/10/2008
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
Predetermined Change
Control Plan Authorized		 No
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