FDA 510(k)

Dakin's Skin and Wound Cleanser

N.º K: K150208 · 2016-07-21

SolicitanteCentury Pharmaceuticals, Inc.

Fecha de decisión2016-07-21

Código de productoFRO

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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Fuente oficial

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