FDA 510(k)

Dakin's Skin and Wound Cleanser

Номер K: K150208 · 2016-07-21

Дата решения2016-07-21

Код продуктаFRO

РешениеSubstantially Equivalent

Описание устройства

Dakin's Skin and Wound Cleanser is the device name listed in this FDA 510(k) record. The listed applicant is Century Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2016-07-21 under 510(k) number K150208. 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 Dakin's Skin and Wound Cleanser?

Dakin's Skin and Wound Cleanser is a medical device that received FDA 510(k) clearance on 2016-07-21. The listed applicant is Century Pharmaceuticals, Inc.. The 510(k) number is K150208.

When did Dakin's Skin and Wound Cleanser receive FDA 510(k) clearance?

Dakin's Skin and Wound Cleanser received FDA 510(k) clearance on 2016-07-21, under 510(k) number K150208.

Who is the listed applicant for Dakin's Skin and Wound Cleanser?

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

What is the FDA product code for Dakin's Skin and Wound Cleanser?

The FDA product code for Dakin's Skin and Wound Cleanser 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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