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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 K082108
Device Name OBC BONE ANCHORED HEARING AID SYSTEM
Applicant
OTICON MEDICAL AB
EKONOMIV 2
GOTHENBURG, ASKIM,  SE SE-436 33
Applicant Contact KAROLIN ISBERG
Correspondent
OTICON MEDICAL AB
EKONOMIV 2
GOTHENBURG, ASKIM,  SE SE-436 33
Correspondent Contact KAROLIN ISBERG
Regulation Number874.3302
Classification Product Code
LXB  
Date Received07/25/2008
Decision Date 11/14/2008
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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