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510(k) K180513

CustomizedBone Service by Fin-Ceramica Faenza S.P.A. — Product Code GXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2018
Date Received
February 27, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Cranioplasty, Preformed, Non-Alterable
Device Class
Class II
Regulation Number
882.5330
Review Panel
NE
Submission Type

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