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FDA 510(k)

Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown

Número K: K200824 · 2020-07-29

RequerenteCardinal Health200, LLC
Data da decisão2020-07-29
Código do produtoFYA
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health200, LLC. It received FDA 510(k) clearance on 2020-07-29 under 510(k) number K200824. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown?

Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown is a medical device that received FDA 510(k) clearance on 2020-07-29. The listed applicant is Cardinal Health200, LLC. The 510(k) number is K200824.

When did Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown receive FDA 510(k) clearance?

Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown received FDA 510(k) clearance on 2020-07-29, under 510(k) number K200824.

Who is the listed applicant for Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown?

The FDA 510(k) record lists Cardinal Health200, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown?

The FDA product code for Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown is FYA.

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Dispositivos Relacionados (Código: FYA)

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Fonte oficial

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