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510(k) K181382

GuardianTM Burr Hole Cover System by St Jude Medical — Product Code GXR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2018
Date Received
May 25, 2018
Clearance Type
Abbreviated
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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