FDA 510(k)

Syringe with safety needle, Safety needle

Número K: K193526 · 2020-07-17

Data da decisão2020-07-17

Código do produtoFMF

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Syringe with safety needle, Safety needle is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Caina Medical Co.,Ltd. It received FDA 510(k) clearance on 2020-07-17 under 510(k) number K193526. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Syringe with safety needle, Safety needle?

Syringe with safety needle, Safety needle is a medical device that received FDA 510(k) clearance on 2020-07-17. The listed applicant is Jiangsu Caina Medical Co.,Ltd. The 510(k) number is K193526.

When did Syringe with safety needle, Safety needle receive FDA 510(k) clearance?

Syringe with safety needle, Safety needle received FDA 510(k) clearance on 2020-07-17, under 510(k) number K193526.

Who is the listed applicant for Syringe with safety needle, Safety needle?

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

What is the FDA product code for Syringe with safety needle, Safety needle?

The FDA product code for Syringe with safety needle, Safety needle is FMF.

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Fonte oficial

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