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510(k) K100205

FRONTIER DEVICES NEURO SYSTEM by Folsom Metal Products, Inc. — Product Code GWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2010
Date Received
January 25, 2010
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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