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510(k) K043427

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2005
Date Received
December 13, 2004
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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