FDA 510(k)

Kendall NPWT Incision Management Dressing Kit

Número K: K191101 · 2020-07-31

Data da decisão2020-07-31

Código do produtoOMP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Kendall NPWT Incision Management Dressing Kit is the device name listed in this FDA 510(k) record. The listed applicant is Cardinalhealth. It received FDA 510(k) clearance on 2020-07-31 under 510(k) number K191101. 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 Kendall NPWT Incision Management Dressing Kit?

Kendall NPWT Incision Management Dressing Kit is a medical device that received FDA 510(k) clearance on 2020-07-31. The listed applicant is Cardinalhealth. The 510(k) number is K191101.

When did Kendall NPWT Incision Management Dressing Kit receive FDA 510(k) clearance?

Kendall NPWT Incision Management Dressing Kit received FDA 510(k) clearance on 2020-07-31, under 510(k) number K191101.

Who is the listed applicant for Kendall NPWT Incision Management Dressing Kit?

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

What is the FDA product code for Kendall NPWT Incision Management Dressing Kit?

The FDA product code for Kendall NPWT Incision Management Dressing Kit is OMP.

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Fonte oficial

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