FDA 510(k)

MTS Penicillin 0.002- 32 µg/mL

Número K: K181889 · 2018-09-13

Data da decisão2018-09-13

Código do produtoJWY

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

MTS Penicillin 0.002- 32 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 2018-09-13 under 510(k) number K181889. 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 Penicillin 0.002- 32 µg/mL?

MTS Penicillin 0.002- 32 µg/mL is a medical device that received FDA 510(k) clearance on 2018-09-13. The listed applicant is Liofilchem s.r.l.. The 510(k) number is K181889.

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

MTS Penicillin 0.002- 32 µg/mL received FDA 510(k) clearance on 2018-09-13, under 510(k) number K181889.

Who is the listed applicant for MTS Penicillin 0.002- 32 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 Penicillin 0.002- 32 µg/mL?

The FDA product code for MTS Penicillin 0.002- 32 µg/mL is JWY.

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Fonte oficial

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