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510(k) K172460

ADHEAR System by Med-El Elektromedizinische Geraete GmbH — Product Code LXB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2018
Date Received
August 14, 2017
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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