FDA 510(k)

Hudson RCI® AddiPak® Unit Dose Vial

N.º K: K231058 · 2024-01-04

Fecha de decisión2024-01-04

Código de productoCAF

Comité asesorAN

DecisiónSubstantially Equivalent

Resumen del dispositivo

Hudson RCI® AddiPak® Unit Dose Vial is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, LP. It received FDA 510(k) clearance on 2024-01-04 under 510(k) number K231058. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Hudson RCI® AddiPak® Unit Dose Vial?

Hudson RCI® AddiPak® Unit Dose Vial is a medical device that received FDA 510(k) clearance on 2024-01-04. The listed applicant is Medline Industries, LP. The 510(k) number is K231058.

When did Hudson RCI® AddiPak® Unit Dose Vial receive FDA 510(k) clearance?

Hudson RCI® AddiPak® Unit Dose Vial received FDA 510(k) clearance on 2024-01-04, under 510(k) number K231058.

Who is the listed applicant for Hudson RCI® AddiPak® Unit Dose Vial?

The FDA 510(k) record lists Medline Industries, LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hudson RCI® AddiPak® Unit Dose Vial?

The FDA product code for Hudson RCI® AddiPak® Unit Dose Vial is CAF.

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Otros registros que enlistan a Medline Industries, LP como solicitante

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Fuente oficial

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