OBC BONE ANCHORED HEARING SYSTEM

Hearing Aid, Bone Conduction, Implanted

OTICON MEDICAL AB

The following data is part of a premarket notification filed by Oticon Medical Ab with the FDA for Obc Bone Anchored Hearing System.

Pre-market Notification Details

Device IDK112053
510k NumberK112053
Device Name:OBC BONE ANCHORED HEARING SYSTEM
ClassificationHearing Aid, Bone Conduction, Implanted
Applicant OTICON MEDICAL AB EKONOMIVAGEN 2 Askim,  SE Se-436 33
ContactKarolin Isberg Jernby
CorrespondentKarolin Isberg Jernby
OTICON MEDICAL AB EKONOMIVAGEN 2 Askim,  SE Se-436 33
Product CodeMAH  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-07-19
Decision Date2011-11-18

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