FDA 510(k)

Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use)

N.º K: K202982 · 2021-10-19

Fecha de decisión2021-10-19

Código de productoFRO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) is the device name listed in this FDA 510(k) record. The listed applicant is Winner Medical Co., Ltd.. It received FDA 510(k) clearance on 2021-10-19 under 510(k) number K202982. 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.

Preguntas frecuentes

What is the Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use)?

Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) is a medical device that received FDA 510(k) clearance on 2021-10-19. The listed applicant is Winner Medical Co., Ltd.. The 510(k) number is K202982.

When did Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) receive FDA 510(k) clearance?

Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) received FDA 510(k) clearance on 2021-10-19, under 510(k) number K202982.

Who is the listed applicant for Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use)?

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

What is the FDA product code for Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use)?

The FDA product code for Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) is FRO. This falls under the Anesthesiology category.

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Otros registros que enlistan a Winner Medical Co., Ltd. como solicitante

K252001Collagen Wound Dressing K250082Procedure mask/Surgical mask/Face mask K231057Antibacterial Gel Wound Dressing K231564Skin and Wound Cleanser K231152Collagen Wound Dressing K221311Antibacterial Bandage

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Dispositivos relacionados (Código: FRO)

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbH K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.