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FDA 510(k)

LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing

K-Number: K223360 · 2024-03-27

ApplicantHuizhou Foryou Medical Devices Co., Ltd.
Decision Date2024-03-27
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing is a medical device manufactured by Huizhou Foryou Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2024-03-27 under approval number K223360. 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® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing?

LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing is a medical device that received FDA 510(k) clearance on 2024-03-27. It is manufactured by Huizhou Foryou Medical Devices Co., Ltd.. The 510(k) number is K223360.

When was LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing approved by the FDA?

LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing received FDA 510(k) clearance on 2024-03-27, under approval number K223360.

What company makes LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing?

LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing is manufactured by Huizhou Foryou Medical Devices Co., Ltd..

What is the FDA product code for LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing?

The FDA product code for LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing is FRO. This falls under the Anesthesiology category.

Other Devices by Huizhou Foryou Medical Devices Co., Ltd.

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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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