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510(k) K190229

Stryker PEEK Customized Cranial Implant Kit by Stryker — Product Code GWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2019
Date Received
February 5, 2019
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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