FDA 510(k)

MTS Ciprofloxacin 0.002 - 32 µg/mL

Número K: K183527 · 2019-03-19

Data da decisão2019-03-19

Código do produtoJWY

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

MTS Ciprofloxacin 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 2019-03-19 under 510(k) number K183527. 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 Ciprofloxacin 0.002 - 32 µg/mL?

MTS Ciprofloxacin 0.002 - 32 µg/mL is a medical device that received FDA 510(k) clearance on 2019-03-19. The listed applicant is Liofilchem s.r.l.. The 510(k) number is K183527.

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

MTS Ciprofloxacin 0.002 - 32 µg/mL received FDA 510(k) clearance on 2019-03-19, under 510(k) number K183527.

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

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

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Dispositivos Relacionados (Código: JWY)

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Fonte oficial

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