FDA 510(k)

LUOFUCON® Silver Collagen Dressing

Número K: K240809 · 2024-12-16

RequerenteHuizhou Foryou Medical Devices Co., Ltd.

Data da decisão2024-12-16

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

LUOFUCON® Silver Collagen Dressing 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 2024-12-16 under 510(k) number K240809. 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.

Perguntas frequentes

What is the LUOFUCON® Silver Collagen Dressing?

LUOFUCON® Silver Collagen Dressing is a medical device that received FDA 510(k) clearance on 2024-12-16. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. The 510(k) number is K240809.

When did LUOFUCON® Silver Collagen Dressing receive FDA 510(k) clearance?

LUOFUCON® Silver Collagen Dressing received FDA 510(k) clearance on 2024-12-16, under 510(k) number K240809.

Who is the listed applicant for LUOFUCON® Silver Collagen Dressing?

The FDA 510(k) record lists Huizhou Foryou Medical Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUOFUCON® Silver Collagen Dressing?

The FDA product code for LUOFUCON® Silver Collagen Dressing is FRO. This falls under the Anesthesiology category.

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Outros registros que listam Huizhou Foryou Medical Devices Co., Ltd. como candidato(a)

K254256LUOFUCON® Wound Matrix K250642LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)K242856LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)K240485LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)K232796LUOFUCON® Collagen Particles (Collagen Wound Dressing)K223360LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing

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Fonte oficial

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