FDA 510(k)

Sterile syringes for single use with/without needle

Número K: K211211 · 2021-10-07

Data da decisão2021-10-07

Código do produtoFMF

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sterile syringes for single use with/without needle is the device name listed in this FDA 510(k) record. The listed applicant is Azur Medical Company, Inc.. It received FDA 510(k) clearance on 2021-10-07 under 510(k) number K211211. 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 Sterile syringes for single use with/without needle?

Sterile syringes for single use with/without needle is a medical device that received FDA 510(k) clearance on 2021-10-07. The listed applicant is Azur Medical Company, Inc.. The 510(k) number is K211211.

When did Sterile syringes for single use with/without needle receive FDA 510(k) clearance?

Sterile syringes for single use with/without needle received FDA 510(k) clearance on 2021-10-07, under 510(k) number K211211.

Who is the listed applicant for Sterile syringes for single use with/without needle?

The FDA 510(k) record lists Azur Medical Company, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile syringes for single use with/without needle?

The FDA product code for Sterile syringes for single use with/without needle is FMF.

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Outros registros que listam Azur Medical Company, Inc. como candidato(a)

K231719Medical Surgical Mask K211210Sterile Auto-Disable Syringes with/without Needle for Single Use K211214Sterile Hypodermic Needles for Single Use

Dispositivos Relacionados (Código: FMF)

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Fonte oficial

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