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FDA 510(k)

LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing

K-Number: K210718 · 2022-03-23

ApplicantHuizhou Foryou Medical Devices Co., Ltd.
Decision Date2022-03-23
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing is a medical device manufactured by Huizhou Foryou Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2022-03-23 under approval number K210718. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing?

LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing is a medical device that received FDA 510(k) clearance on 2022-03-23. It is manufactured by Huizhou Foryou Medical Devices Co., Ltd.. The 510(k) number is K210718.

When was LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing approved by the FDA?

LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing received FDA 510(k) clearance on 2022-03-23, under approval number K210718.

What company makes LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing?

LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing is manufactured by Huizhou Foryou Medical Devices Co., Ltd..

What is the FDA product code for LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing?

The FDA product code for LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing is FRO. This falls under the Anesthesiology category.

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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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