FDA 510(k)

Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing

Número K: K202783 · 2022-01-14

RequerenteSmith & Nephew Medical Limited

Data da decisão2022-01-14

Código do produtoOMP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Medical Limited. It received FDA 510(k) clearance on 2022-01-14 under 510(k) number K202783. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing?

Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing is a medical device that received FDA 510(k) clearance on 2022-01-14. The listed applicant is Smith & Nephew Medical Limited. The 510(k) number is K202783.

When did Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing receive FDA 510(k) clearance?

Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing received FDA 510(k) clearance on 2022-01-14, under 510(k) number K202783.

Who is the listed applicant for Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing?

The FDA 510(k) record lists Smith & Nephew Medical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing?

The FDA product code for Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing is OMP.

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Outros registros que listam Smith & Nephew Medical Limited como candidato(a)

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Fonte oficial

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