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510(k) K143697

Biomet Proximal Humerus Plating System by Biomet Manufacturing — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2015
Date Received
December 24, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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