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FDA 510(k)

LUOFUCON Silicone Ag foam dressing

K-Number: K160022 · 2016-08-17

ApplicantHuizhou Foryou Medical Devices Co., Ltd.
Decision Date2016-08-17
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

LUOFUCON Silicone Ag foam dressing is a medical device manufactured by Huizhou Foryou Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2016-08-17 under approval number K160022. 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 foam dressing is a medical device that received FDA 510(k) clearance on 2016-08-17. It is manufactured by Huizhou Foryou Medical Devices Co., Ltd.. The 510(k) number is K160022.

When was LUOFUCON Silicone Ag foam dressing approved by the FDA?

LUOFUCON Silicone Ag foam dressing received FDA 510(k) clearance on 2016-08-17, under approval number K160022.

What company makes LUOFUCON Silicone Ag foam dressing?

LUOFUCON Silicone Ag foam dressing is manufactured by Huizhou Foryou Medical Devices Co., Ltd..

What is the FDA product code for LUOFUCON Silicone Ag foam dressing?

The FDA product code for LUOFUCON Silicone Ag foam dressing is FRO. This falls under the Anesthesiology category.

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

K170077LUOFUCON Silicone Ag Foam Dressing with Border K172554LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing K173196SUNTOUCH Dental Dressing K201852Surgical Mask-Model Number: Ear Loop, Flat-Pleated K201016LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use) K213598LUOFUCON Collagen Wound Dressing

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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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