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510(k) K153248

PEEK Customized Cranial Implant by Stryker — Product Code GWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2016
Date Received
November 9, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Cranioplasty, Preformed, Alterable
Device Class
Class II
Regulation Number
882.5320
Review Panel
NE
Submission Type

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