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510(k) K163148

BePOD® Foot Screws by Fournitures Hospitalieres Industrie — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2017
Date Received
November 9, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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