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510(k) K210128

INTEGRA Wound Matrix (Macro-Channels) by Integra LifeSciences Corporation — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2021
Date Received
January 19, 2021
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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