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510(k) K190540

Ponto 4 by Oticon Medical AB — Product Code LXB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2019
Date Received
March 4, 2019
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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