FDA 510(k)

Vestimento de Ferida de Alginato de Prata Algidex

Número K: K173072 · 2018-04-04

Data da decisão2018-04-04

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Algidex Ag Silver Alginate Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Deroyal Industries, Inc.. It received FDA 510(k) clearance on 2018-04-04 under 510(k) number K173072. 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 Algidex Ag Silver Alginate Wound Dressing?

Algidex Ag Silver Alginate Wound Dressing is a medical device that received FDA 510(k) clearance on 2018-04-04. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K173072.

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

Algidex Ag Silver Alginate Wound Dressing received FDA 510(k) clearance on 2018-04-04, under 510(k) number K173072.

Who is the listed applicant for Algidex Ag Silver Alginate Wound Dressing?

The FDA 510(k) record lists Deroyal Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Fonte oficial

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