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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 K121228
Device Name PONTO 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
Correspondent Contact KAROLIN ISBERG JERNBY
Regulation Number874.3302
Classification Product Code
MAH  
Date Received04/23/2012
Decision Date 09/07/2012
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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