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510(k) K163456

DuraGen Secure Dural Regeneration Matrix by Integra LifeSciences Corporation — Product Code GXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2017
Date Received
December 9, 2016
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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