FDA 510(k)

Disposable Sterile Syringe, Disposable Sterile Syringe with Needle

Número K: K210991 · 2021-08-26

Data da decisão2021-08-26

Código do produtoFMF

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Sterile Syringe, Disposable Sterile Syringe with Needle is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Antmed Co., Ltd.. It received FDA 510(k) clearance on 2021-08-26 under 510(k) number K210991. 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 with Needle?

Disposable Sterile Syringe, Disposable Sterile Syringe with Needle is a medical device that received FDA 510(k) clearance on 2021-08-26. The listed applicant is Guangdong Antmed Co., Ltd.. The 510(k) number is K210991.

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

Disposable Sterile Syringe, Disposable Sterile Syringe with Needle received FDA 510(k) clearance on 2021-08-26, under 510(k) number K210991.

Who is the listed applicant for Disposable Sterile Syringe, Disposable Sterile Syringe with Needle?

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

What is the FDA product code for Disposable Sterile Syringe, Disposable Sterile Syringe with Needle?

The FDA product code for Disposable Sterile Syringe, Disposable Sterile Syringe with Needle is FMF.

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Fonte oficial

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