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FDA 510(k)

Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large

N.º K: K161570 · 2016-08-29

SolicitanteLc Medical Concepts, Inc.
Fecha de decisión2016-08-29
Código de productoOMP
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large is the device name listed in this FDA 510(k) record. The listed applicant is Lc Medical Concepts, Inc.. It received FDA 510(k) clearance on 2016-08-29 under 510(k) number K161570. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large?

Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large is a medical device that received FDA 510(k) clearance on 2016-08-29. The listed applicant is Lc Medical Concepts, Inc.. The 510(k) number is K161570.

When did Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large receive FDA 510(k) clearance?

Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large received FDA 510(k) clearance on 2016-08-29, under 510(k) number K161570.

Who is the listed applicant for Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large?

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

What is the FDA product code for Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large?

The FDA product code for Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large is OMP.

Ensayos clínicos relacionados

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Dispositivos relacionados (Código: OMP)

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

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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