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510(k) K052211

DUREPAIR DURA REGENERATION MATRIX by Medtronic Neurosurgery — Product Code GXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2005
Date Received
August 15, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dura Substitute
Device Class
Class II
Regulation Number
882.5910
Review Panel
NE
Submission Type

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  • K183513 — XenoSure Dura Biologic Patch (June 13, 2019)
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  • K161278 — Cerafix Dura Substitute (August 8, 2016)
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