FDA 510(k)

MTS Omadacycline 0.002 - 32 ug/mL

N.º K: K200180 · 2020-03-20

Fecha de decisión2020-03-20

Código de productoJWY

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

MTS Omadacycline 0.002 - 32 ug/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 2020-03-20 under 510(k) number K200180. 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 MTS Omadacycline 0.002 - 32 ug/mL?

MTS Omadacycline 0.002 - 32 ug/mL is a medical device that received FDA 510(k) clearance on 2020-03-20. The listed applicant is Liofilchem s.r.l.. The 510(k) number is K200180.

When did MTS Omadacycline 0.002 - 32 ug/mL receive FDA 510(k) clearance?

MTS Omadacycline 0.002 - 32 ug/mL received FDA 510(k) clearance on 2020-03-20, under 510(k) number K200180.

Who is the listed applicant for MTS Omadacycline 0.002 - 32 ug/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 Omadacycline 0.002 - 32 ug/mL?

The FDA product code for MTS Omadacycline 0.002 - 32 ug/mL is JWY.

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Fuente oficial

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