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510(k) K152342

Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover by St Jude Medical — Product Code GXR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2016
Date Received
August 19, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cover, Burr Hole
Device Class
Class II
Regulation Number
882.5250
Review Panel
NE
Submission Type

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