FDA 510(k)

Disposable Sterile Syringe

Número K: K221777 · 2023-10-06

RequerenteWeihai Shengjie Medical Technology Co., Ltd.

Data da decisão2023-10-06

Código do produtoFMF

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Sterile Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Weihai Shengjie Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-10-06 under 510(k) number K221777. 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 Disposable Sterile Syringe?

Disposable Sterile Syringe is a medical device that received FDA 510(k) clearance on 2023-10-06. The listed applicant is Weihai Shengjie Medical Technology Co., Ltd.. The 510(k) number is K221777.

When did Disposable Sterile Syringe receive FDA 510(k) clearance?

Disposable Sterile Syringe received FDA 510(k) clearance on 2023-10-06, under 510(k) number K221777.

Who is the listed applicant for Disposable Sterile Syringe?

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

What is the FDA product code for Disposable Sterile Syringe?

The FDA product code for Disposable Sterile Syringe is FMF.

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Fonte oficial

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