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FDA 510(k)

UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope

N.º K: K183263 · 2019-06-14

SolicitanteUnipack Medical Corporation
Fecha de decisión2019-06-14
Código de productoPEM
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope is the device name listed in this FDA 510(k) record. The listed applicant is Unipack Medical Corporation. It received FDA 510(k) clearance on 2019-06-14 under 510(k) number K183263. 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 UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope?

UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope is a medical device that received FDA 510(k) clearance on 2019-06-14. The listed applicant is Unipack Medical Corporation. The 510(k) number is K183263.

When did UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope receive FDA 510(k) clearance?

UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope received FDA 510(k) clearance on 2019-06-14, under 510(k) number K183263.

Who is the listed applicant for UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope?

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

What is the FDA product code for UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope?

The FDA product code for UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope 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

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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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