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510(k) K170725

Stryker Universal Mesh by Stryker — Product Code GWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2017
Date Received
March 9, 2017
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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