FDA 510(k)

MTS Plazomicin 0.016-256 µg/mL

Número K: K181708 · 2018-07-31

Data da decisão2018-07-31

Código do produtoJWY

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

MTS Plazomicin 0.016-256 µg/mL 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 2018-07-31 under 510(k) number K181708. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MTS Plazomicin 0.016-256 µg/mL?

MTS Plazomicin 0.016-256 µg/mL is a medical device that received FDA 510(k) clearance on 2018-07-31. The listed applicant is Liofilchem s.r.l.. The 510(k) number is K181708.

When did MTS Plazomicin 0.016-256 µg/mL receive FDA 510(k) clearance?

MTS Plazomicin 0.016-256 µg/mL received FDA 510(k) clearance on 2018-07-31, under 510(k) number K181708.

Who is the listed applicant for MTS Plazomicin 0.016-256 µg/mL?

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 MTS Plazomicin 0.016-256 µg/mL?

The FDA product code for MTS Plazomicin 0.016-256 µg/mL is JWY.

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Outros registros que listam Liofilchem s.r.l. como candidato(a)

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Dispositivos Relacionados (Código: JWY)

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Fonte oficial

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