FDA 510(k)

Prevena Restor Adapti-Form Dressing

Número K: K220660 · 2022-07-01

Data da decisão2022-07-01

Código do produtoOMP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Prevena Restor Adapti-Form Dressing is the device name listed in this FDA 510(k) record. The listed applicant is 3M Healthcare Business Group. It received FDA 510(k) clearance on 2022-07-01 under 510(k) number K220660. 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 Prevena Restor Adapti-Form Dressing?

Prevena Restor Adapti-Form Dressing is a medical device that received FDA 510(k) clearance on 2022-07-01. The listed applicant is 3M Healthcare Business Group. The 510(k) number is K220660.

When did Prevena Restor Adapti-Form Dressing receive FDA 510(k) clearance?

Prevena Restor Adapti-Form Dressing received FDA 510(k) clearance on 2022-07-01, under 510(k) number K220660.

Who is the listed applicant for Prevena Restor Adapti-Form Dressing?

The FDA 510(k) record lists 3M Healthcare Business Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Prevena Restor Adapti-Form Dressing?

The FDA product code for Prevena Restor Adapti-Form Dressing is OMP.

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Outros registros que listam 3M Healthcare Business Group como candidato(a)

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