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510(k) K150463

CalcaNail Orthopedic Nail by Fournitures Hospitalieres Industrie — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2015
Date Received
February 23, 2015
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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