FDA 510(k)

ALGS6 Ag Alginato de Ferimento

Número K: K172570 · 2018-05-11

RequerenteFoshan United Medical Technologies, Ltd.

Data da decisão2018-05-11

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

ALGS6 Ag Alginate Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Foshan United Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2018-05-11 under 510(k) number K172570. 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 ALGS6 Ag Alginate Wound Dressing?

ALGS6 Ag Alginate Wound Dressing is a medical device that received FDA 510(k) clearance on 2018-05-11. The listed applicant is Foshan United Medical Technologies, Ltd.. The 510(k) number is K172570.

When did ALGS6 Ag Alginate Wound Dressing receive FDA 510(k) clearance?

ALGS6 Ag Alginate Wound Dressing received FDA 510(k) clearance on 2018-05-11, under 510(k) number K172570.

Who is the listed applicant for ALGS6 Ag Alginate Wound Dressing?

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

What is the FDA product code for ALGS6 Ag Alginate Wound Dressing?

The FDA product code for ALGS6 Ag Alginate Wound Dressing is FRO. This falls under the Anesthesiology category.

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Outros registros que listam Foshan United Medical Technologies, Ltd. como candidato(a)

K233111ALGS2 Ag Alginato de Ferimento Rx; ALGS2 Ag Alginato de Ferimento OTC; ALGS2S Alginato de Ferimento de Reforço Ag Rx; ALGS2S Alginato de Ferimento de Reforço Ag OTC

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.

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