FDA 510(k)

Longterm NPWT Foam Dressing Kit

Número K: K182458 · 2019-05-23

RequerenteZhejiang Longterm Medical Technology Co., Ltd.

Data da decisão2019-05-23

Código do produtoOMP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Longterm NPWT Foam Dressing Kit is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Longterm Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-05-23 under 510(k) number K182458. 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 Longterm NPWT Foam Dressing Kit?

Longterm NPWT Foam Dressing Kit is a medical device that received FDA 510(k) clearance on 2019-05-23. The listed applicant is Zhejiang Longterm Medical Technology Co., Ltd.. The 510(k) number is K182458.

When did Longterm NPWT Foam Dressing Kit receive FDA 510(k) clearance?

Longterm NPWT Foam Dressing Kit received FDA 510(k) clearance on 2019-05-23, under 510(k) number K182458.

Who is the listed applicant for Longterm NPWT Foam Dressing Kit?

The FDA 510(k) record lists Zhejiang Longterm Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Longterm NPWT Foam Dressing Kit?

The FDA product code for Longterm NPWT Foam Dressing Kit is OMP.

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