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510(k) K151382

Patient Contoured Implant-PEEK (PCI-PEEK) by KLS Martin L.P. — Product Code GXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2015
Date Received
May 22, 2015
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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