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510(k) K191992

PELNAC Bilayer Wound Matrix by Gunze Limited — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2020
Date Received
July 25, 2019
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

Other clearances by Gunze Limited

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  • K130997 — NEOVEIL (November 15, 2013)

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