FDA 510(k)

Silverlon Wound Contact, Burn Contact Dressings

Номер K: K221218 · 2022-10-26

Дата решения2022-10-26

Код продуктаFRO

РешениеSubstantially Equivalent

Описание устройства

Silverlon Wound Contact, Burn Contact Dressings is the device name listed in this FDA 510(k) record. The listed applicant is Argentum Medical, Inc.. It received FDA 510(k) clearance on 2022-10-26 under 510(k) number K221218. 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.

Часто задаваемые вопросы

What is the Silverlon Wound Contact, Burn Contact Dressings?

Silverlon Wound Contact, Burn Contact Dressings is a medical device that received FDA 510(k) clearance on 2022-10-26. The listed applicant is Argentum Medical, Inc.. The 510(k) number is K221218.

When did Silverlon Wound Contact, Burn Contact Dressings receive FDA 510(k) clearance?

Silverlon Wound Contact, Burn Contact Dressings received FDA 510(k) clearance on 2022-10-26, under 510(k) number K221218.

Who is the listed applicant for Silverlon Wound Contact, Burn Contact Dressings?

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

What is the FDA product code for Silverlon Wound Contact, Burn Contact Dressings?

The FDA product code for Silverlon Wound Contact, Burn Contact Dressings is FRO. This falls under the Anesthesiology category.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: 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.

Официальный источник

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