FDA 510(k)

MTS Lefamulin 0.016- 256 µg/mL

Número K: K200308 · 2020-04-06

Data da decisão2020-04-06

Código do produtoJWY

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

MTS Lefamulin 0.016- 256 µg/mL is the device name listed in this FDA 510(k) record. The listed applicant is Liofilchem S. R. 1.. It received FDA 510(k) clearance on 2020-04-06 under 510(k) number K200308. 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 Lefamulin 0.016- 256 µg/mL?

MTS Lefamulin 0.016- 256 µg/mL is a medical device that received FDA 510(k) clearance on 2020-04-06. The listed applicant is Liofilchem S. R. 1.. The 510(k) number is K200308.

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

MTS Lefamulin 0.016- 256 µg/mL received FDA 510(k) clearance on 2020-04-06, under 510(k) number K200308.

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

The FDA 510(k) record lists Liofilchem S. R. 1. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MTS Lefamulin 0.016- 256 µg/mL?

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

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Fonte oficial

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