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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 K112053
Device Name OBC BONE ANCHORED HEARING SYSTEM
Applicant
OTICON MEDICAL AB
ekonomivagen 2
askim,  SE se-436 33
Applicant Contact karolin isberg jernby
Correspondent
OTICON MEDICAL AB
ekonomivagen 2
askim,  SE se-436 33
Correspodent Contact karolin isberg jernby
Regulation Number874.3300
Classification Product Code
MAH  
Date Received07/19/2011
Decision Date 11/18/2011
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
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