FDA 510(k)

Blood Collection Needle (with/without Needle Holder)

Número K: K223323 · 2023-03-24

RequerenteAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

Data da decisão2023-03-24

Código do produtoJKA

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

Blood Collection Needle (with/without Needle Holder) is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. It received FDA 510(k) clearance on 2023-03-24 under 510(k) number K223323. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Blood Collection Needle (with/without Needle Holder)?

Blood Collection Needle (with/without Needle Holder) is a medical device that received FDA 510(k) clearance on 2023-03-24. The listed applicant is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. The 510(k) number is K223323.

When did Blood Collection Needle (with/without Needle Holder) receive FDA 510(k) clearance?

Blood Collection Needle (with/without Needle Holder) received FDA 510(k) clearance on 2023-03-24, under 510(k) number K223323.

Who is the listed applicant for Blood Collection Needle (with/without Needle Holder)?

The FDA 510(k) record lists Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Blood Collection Needle (with/without Needle Holder)?

The FDA product code for Blood Collection Needle (with/without Needle Holder) is JKA.

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Fonte oficial

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