FDA 510(k)

ComASP Cefiderocol 0.008-128

N.º K: K230479 · 2023-05-18

Fecha de decisión2023-05-18

Código de productoJWY

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

ComASP Cefiderocol 0.008-128 is the device name listed in this FDA 510(k) record. The listed applicant is Liofilchem s.r.l.. It received FDA 510(k) clearance on 2023-05-18 under 510(k) number K230479. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ComASP Cefiderocol 0.008-128?

ComASP Cefiderocol 0.008-128 is a medical device that received FDA 510(k) clearance on 2023-05-18. The listed applicant is Liofilchem s.r.l.. The 510(k) number is K230479.

When did ComASP Cefiderocol 0.008-128 receive FDA 510(k) clearance?

ComASP Cefiderocol 0.008-128 received FDA 510(k) clearance on 2023-05-18, under 510(k) number K230479.

Who is the listed applicant for ComASP Cefiderocol 0.008-128?

The FDA 510(k) record lists Liofilchem s.r.l. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ComASP Cefiderocol 0.008-128?

The FDA product code for ComASP Cefiderocol 0.008-128 is JWY.

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Fuente oficial

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