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FDA 510(k)

Plasdent Disposable Barrier Sleeves and Barrier Film

N.º K: K201604 · 2020-12-23

SolicitantePlasdent Corporation
Fecha de decisión2020-12-23
Código de productoPEM
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Plasdent Disposable Barrier Sleeves and Barrier Film is the device name listed in this FDA 510(k) record. The listed applicant is Plasdent Corporation. It received FDA 510(k) clearance on 2020-12-23 under 510(k) number K201604. The device is classified under product code PEM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Plasdent Disposable Barrier Sleeves and Barrier Film?

Plasdent Disposable Barrier Sleeves and Barrier Film is a medical device that received FDA 510(k) clearance on 2020-12-23. The listed applicant is Plasdent Corporation. The 510(k) number is K201604.

When did Plasdent Disposable Barrier Sleeves and Barrier Film receive FDA 510(k) clearance?

Plasdent Disposable Barrier Sleeves and Barrier Film received FDA 510(k) clearance on 2020-12-23, under 510(k) number K201604.

Who is the listed applicant for Plasdent Disposable Barrier Sleeves and Barrier Film?

The FDA 510(k) record lists Plasdent Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Plasdent Disposable Barrier Sleeves and Barrier Film?

The FDA product code for Plasdent Disposable Barrier Sleeves and Barrier Film is PEM.

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Dispositivos relacionados (Código: PEM)

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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