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510(k) K082108

OBC BONE ANCHORED HEARING AID SYSTEM by Oticon Medical AB — Product Code LXB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2008
Date Received
July 25, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hearing Aid, Bone Conduction
Device Class
Class II
Regulation Number
874.3302
Review Panel
EN
Submission Type

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