FDA 510(k)

Sterile Level 3 Surgical Gown

Número K: K211399 · 2022-07-22

RequerenteBarco Tekstil Sanayi VE Ticaret A.S.

Data da decisão2022-07-22

Código do produtoFYA

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sterile Level 3 Surgical Gown is the device name listed in this FDA 510(k) record. The listed applicant is Barco Tekstil Sanayi VE Ticaret A.S.. It received FDA 510(k) clearance on 2022-07-22 under 510(k) number K211399. 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 Sterile Level 3 Surgical Gown?

Sterile Level 3 Surgical Gown is a medical device that received FDA 510(k) clearance on 2022-07-22. The listed applicant is Barco Tekstil Sanayi VE Ticaret A.S.. The 510(k) number is K211399.

When did Sterile Level 3 Surgical Gown receive FDA 510(k) clearance?

Sterile Level 3 Surgical Gown received FDA 510(k) clearance on 2022-07-22, under 510(k) number K211399.

Who is the listed applicant for Sterile Level 3 Surgical Gown?

The FDA 510(k) record lists Barco Tekstil Sanayi VE Ticaret A.S. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Level 3 Surgical Gown?

The FDA product code for Sterile Level 3 Surgical Gown is FYA.

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Dispositivos Relacionados (Código: FYA)

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Fonte oficial

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