FDA 510(k)

LUOFUCON 银伤口凝胶，LUOFUCON 银抗菌伤口凝胶

K号: K211123 · 2022-04-22

申请人Huizhou Foryou Medical Devices Co., Ltd.

决定日期2022-04-22

产品代码FRO

决定实质等同

器械摘要

LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel is the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2022-04-22 under 510(k) number K211123. 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.

常见问题

What is the LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel?

LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel is a medical device that received FDA 510(k) clearance on 2022-04-22. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. The 510(k) number is K211123.

When did LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel receive FDA 510(k) clearance?

LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel received FDA 510(k) clearance on 2022-04-22, under 510(k) number K211123.

Who is the listed applicant for LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel?

FDA 510(k)记录将惠州友康医疗设备有限公司列为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel?

The FDA product code for LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel is FRO. This falls under the Anesthesiology category.

列明Huizhou Foryou Medical Devices Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K254256LUOFUCON® 创面基质 K250642LUOFUCON® 皮肤和伤口清洁剂（喷雾、雾状、挤压、瓶装）K240809LUOFUCON® 银胶原敷料 K242856LUOFUCON® 硅胶银离子泡沫敷料（处方用药）/ LUOFUCON® 硅胶银离子抗菌泡沫敷料（非处方用药）(边缘型、边缘型轻便、无边缘型和转移型)K240485LUOFUCON® 额外银凝胶纤维敷料 Plus（处方用药），LUOFUCON® 银抗菌凝胶纤维敷料 Plus（非处方用药）K232796LUOFUCON® 胶原颗粒（胶原蛋白伤口敷料）

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