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510(k) K152481

DURAFORM Dural Graft Implant by Codman & Shurtleff, Inc. — Product Code GXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2015
Date Received
August 31, 2015
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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  • K161370 — Durepair Dura Regeneration Matrix (November 2, 2016)
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