PELNAC Meshed Bilayer Wound Matrix

Dressing, Wound, Collagen

Gunze Limited

The following data is part of a premarket notification filed by Gunze Limited with the FDA for Pelnac Meshed Bilayer Wound Matrix.

Pre-market Notification Details

Device IDK213498
510k NumberK213498
Device Name:PELNAC Meshed Bilayer Wound Matrix
ClassificationDressing, Wound, Collagen
Applicant Gunze Limited 46 Natsumegaichi, Aono Ayabe, Kyoto,  JP 623-8513
ContactHidenori Nishioka
CorrespondentStuart R Goldman
Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin,  TX  78746
Product CodeKGN  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-01
Decision Date2022-07-14

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