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510(k) K081635

INTEGRA MESHED BILAYER WOUND MATRIX by Integra Lifesciences Corp. — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2008
Date Received
June 11, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wound Dressing With Animal-Derived Material(S)
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

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