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510(k) K242146

BIOBRANE Temporary Wound Dressing; BIOBRANE Glove by Smith & Nephew Medical Limited — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2024
Date Received
July 23, 2024
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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