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FDA 510(k)

PELNAC Meshed Bilayer Wound Matrix

K-Number: K213498 · 2022-07-14

ApplicantGunze Limited
Decision Date2022-07-14
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

PELNAC Meshed Bilayer Wound Matrix is a medical device manufactured by Gunze Limited. It received FDA 510(k) clearance on 2022-07-14 under approval number K213498. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PELNAC Meshed Bilayer Wound Matrix?

PELNAC Meshed Bilayer Wound Matrix is a medical device that received FDA 510(k) clearance on 2022-07-14. It is manufactured by Gunze Limited. The 510(k) number is K213498.

When was PELNAC Meshed Bilayer Wound Matrix approved by the FDA?

PELNAC Meshed Bilayer Wound Matrix received FDA 510(k) clearance on 2022-07-14, under approval number K213498.

What company makes PELNAC Meshed Bilayer Wound Matrix?

PELNAC Meshed Bilayer Wound Matrix is manufactured by Gunze Limited.

What is the FDA product code for PELNAC Meshed Bilayer Wound Matrix?

The FDA product code for PELNAC Meshed Bilayer Wound Matrix is KGN.

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Other Devices by Gunze Limited

K191992PELNAC Bilayer Wound Matrix K221487NEOVEIL Staple Line Reinforcement K213573PELNAC Wound Matrix

Related Devices (Code: KGN)

K160136Flowable Wound MatrixCook Biotech Incorporated K152600Collagen Dental Wound DressingsCollagen Matrix, Inc. K153754MicroMatrixAcell, Inc. K153690PriMatrix Dermal Repair ScaffoldTei Biosciences, Inc. K172010gel-e BandageGel-E, Inc. (Formerly Remedium Technologies, Inc.) K171842Geistlich Wound MatrixGeistlich Pharma AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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