FDA 510(k)

Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use

Numéro K : K212846 · 2022-08-30

DemandeurJiangsu Jichun Medical Devices Co., Ltd.

Date de décision2022-08-30

Code produitFMF

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Jichun Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2022-08-30 under 510(k) number K212846. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use?

Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use is a medical device that received FDA 510(k) clearance on 2022-08-30. The listed applicant is Jiangsu Jichun Medical Devices Co., Ltd.. The 510(k) number is K212846.

When did Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use receive FDA 510(k) clearance?

Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use received FDA 510(k) clearance on 2022-08-30, under 510(k) number K212846.

Who is the listed applicant for Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use?

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

What is the FDA product code for Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use?

The FDA product code for Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use is FMF.

Essais cliniques associés

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Dispositifs connexes (Code : FMF)

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Source officielle

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