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FDA 510(k)

MTR550 (Tentative) Antimicrobial Silver Wound Gel

N.º K: K152519 · 2016-06-02

SolicitanteMedical Technology Research, Inc.
Fecha de decisión2016-06-02
Código de productoFRO
DecisiónSubstantially Equivalent

Resumen del dispositivo

MTR550 (Tentative) Antimicrobial Silver Wound Gel is the device name listed in this FDA 510(k) record. The listed applicant is Medical Technology Research, Inc.. It received FDA 510(k) clearance on 2016-06-02 under 510(k) number K152519. 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 MTR550 (Tentative) Antimicrobial Silver Wound Gel?

MTR550 (Tentative) Antimicrobial Silver Wound Gel is a medical device that received FDA 510(k) clearance on 2016-06-02. The listed applicant is Medical Technology Research, Inc.. The 510(k) number is K152519.

When did MTR550 (Tentative) Antimicrobial Silver Wound Gel receive FDA 510(k) clearance?

MTR550 (Tentative) Antimicrobial Silver Wound Gel received FDA 510(k) clearance on 2016-06-02, under 510(k) number K152519.

Who is the listed applicant for MTR550 (Tentative) Antimicrobial Silver Wound Gel?

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

What is the FDA product code for MTR550 (Tentative) Antimicrobial Silver Wound Gel?

The FDA product code for MTR550 (Tentative) Antimicrobial Silver Wound Gel is FRO. This falls under the Anesthesiology category.

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Dispositivos relacionados (Código: FRO)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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