FDA 510(k)

LUOFUCON Colagénio Curativo

Número K: K213598 · 2022-09-20

RequerenteHuizhou Foryou Medical Devices Co., Ltd.

Data da decisão2022-09-20

Código do produtoKGN

DecisãoSubstantially Equivalent

Resumo do dispositivo

LUOFUCON Collagen Wound 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 2022-09-20 under 510(k) number K213598. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LUOFUCON Collagen Wound Dressing?

LUOFUCON Collagen Wound Dressing is a medical device that received FDA 510(k) clearance on 2022-09-20. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. The 510(k) number is K213598.

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

LUOFUCON Collagen Wound Dressing received FDA 510(k) clearance on 2022-09-20, under 510(k) number K213598.

Who is the listed applicant for LUOFUCON Collagen Wound 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 Collagen Wound Dressing?

The FDA product code for LUOFUCON Collagen Wound Dressing is KGN.

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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.)K240809LUOFUCON® Silver Collagen Dressing 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)

Ver todos os 18 dispositivos →

Dispositivos Relacionados (Código: KGN)

K260652ColActive PlusCovalon Technologies, Ltd.K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP)Berkeley Advanced Biomaterials K260596Collagen Wound PowderVentris Medical K260669Endoform Dermal TemplateAroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, Inc.

Fonte oficial

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