FDA 510(k)

Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle

Número K: K212033 · 2022-08-17

RequerenteShandong Zhushi Pharmaceutical Group Co., Ltd.

Data da decisão2022-08-17

Código do produtoFMF

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Zhushi Pharmaceutical Group Co., Ltd.. It received FDA 510(k) clearance on 2022-08-17 under 510(k) number K212033. 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, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle?

Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle is a medical device that received FDA 510(k) clearance on 2022-08-17. The listed applicant is Shandong Zhushi Pharmaceutical Group Co., Ltd.. The 510(k) number is K212033.

When did Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle receive FDA 510(k) clearance?

Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle received FDA 510(k) clearance on 2022-08-17, under 510(k) number K212033.

Who is the listed applicant for Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle?

The FDA 510(k) record lists Shandong Zhushi Pharmaceutical Group Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle?

The FDA product code for Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle is FMF.

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Fonte oficial

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