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510(k) K072113

INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301 by Integra Lifesciences Corp. — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2007
Date Received
August 1, 2007
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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