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510(k) K200127

TELEGRAPH® EVOLUTION Humeral Nailing System by FH Industrie — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 2020
Date Received
January 21, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type

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