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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 K152820
Device Name Ponto Bone Anchored Hearing System
Applicant
OTICON MEDICAL AB
DATAVAGEN 37B
ASKIM,  SE 436 32
Applicant Contact CAROLINA ANKER WESSLING
Correspondent
OTICON MEDICAL AB
DATAVAGEN 37B
ASKIM,  SE 436 32
Correspondent Contact CAROLINA ANKER WESSLING
Regulation Number874.3302
Classification Product Code
MAH  
Subsequent Product Code
LXB  
Date Received09/28/2015
Decision Date 01/22/2016
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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