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510(k) K072207

DURAGEN XS DURAL REGENERATION MATRIX by Integra Lifesciences Corp. — Product Code GXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2007
Date Received
August 8, 2007
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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