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FDA 510(k)

Procellera Composite Antibacterial Wound Dressing

N.º K: K180533 · 2018-12-10

SolicitanteVomaris Wound Care, Inc.
Fecha de decisión2018-12-10
Código de productoFRO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Procellera Composite Antibacterial Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Vomaris Wound Care, Inc.. It received FDA 510(k) clearance on 2018-12-10 under 510(k) number K180533. 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 Procellera Composite Antibacterial Wound Dressing?

Procellera Composite Antibacterial Wound Dressing is a medical device that received FDA 510(k) clearance on 2018-12-10. The listed applicant is Vomaris Wound Care, Inc.. The 510(k) number is K180533.

When did Procellera Composite Antibacterial Wound Dressing receive FDA 510(k) clearance?

Procellera Composite Antibacterial Wound Dressing received FDA 510(k) clearance on 2018-12-10, under 510(k) number K180533.

Who is the listed applicant for Procellera Composite Antibacterial Wound Dressing?

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

What is the FDA product code for Procellera Composite Antibacterial Wound Dressing?

The FDA product code for Procellera Composite Antibacterial Wound Dressing 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.

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Fuente oficial

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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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