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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 K142678
Device Name Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm
Applicant
OTICON MEDICAL AB
EKONOMIVAGEN 2
ASKIM,  SE SE-436 33
Applicant Contact Carolina Anker Wessling
Correspondent
OTICON MEDICAL AB
EKONOMIVAGEN 2
ASKIM,  SE SE-436 33
Correspondent Contact Carolina Anker Wessling
Regulation Number874.3302
Classification Product Code
MAH  
Date Received09/19/2014
Decision Date 01/21/2015
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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