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510(k) K152076

PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority by Stryker — Product Code GWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2015
Date Received
July 27, 2015
Clearance Type
Special
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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