FDA 510(k)

LUOFUCON® Collagen Particles (Collagen Wound Dressing)

N.º K: K232796 · 2024-04-25

SolicitanteHuizhou Foryou Medical Devices Co., Ltd.

Fecha de decisión2024-04-25

Código de productoKGN

DecisiónSubstantially Equivalent

Resumen del dispositivo

LUOFUCON® Collagen Particles (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 2024-04-25 under 510(k) number K232796. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the LUOFUCON® Collagen Particles (Collagen Wound Dressing)?

LUOFUCON® Collagen Particles (Collagen Wound Dressing) is a medical device that received FDA 510(k) clearance on 2024-04-25. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. The 510(k) number is K232796.

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

LUOFUCON® Collagen Particles (Collagen Wound Dressing) received FDA 510(k) clearance on 2024-04-25, under 510(k) number K232796.

Who is the listed applicant for LUOFUCON® Collagen Particles (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 Particles (Collagen Wound Dressing)?

The FDA product code for LUOFUCON® Collagen Particles (Collagen Wound Dressing) is KGN.

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Otros registros que enlistan a Huizhou Foryou Medical Devices Co., Ltd. como solicitante

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)K223360LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing

Ver todos los 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.

Fuente oficial

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