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510(k) K092388

DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO by Integra LifeSciences Corporation — Product Code GXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2010
Date Received
August 5, 2009
Clearance Type
Traditional
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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