FDA 510(k)

Sterile Syringe With Safety Needle

Número K: K211753 · 2021-10-14

RequerenteJiangxi Hongda Medical Equipment Group , Ltd.

Data da decisão2021-10-14

Código do produtoMEG

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sterile Syringe With Safety Needle is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Hongda Medical Equipment Group , Ltd.. It received FDA 510(k) clearance on 2021-10-14 under 510(k) number K211753. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sterile Syringe With Safety Needle?

Sterile Syringe With Safety Needle is a medical device that received FDA 510(k) clearance on 2021-10-14. The listed applicant is Jiangxi Hongda Medical Equipment Group , Ltd.. The 510(k) number is K211753.

When did Sterile Syringe With Safety Needle receive FDA 510(k) clearance?

Sterile Syringe With Safety Needle received FDA 510(k) clearance on 2021-10-14, under 510(k) number K211753.

Who is the listed applicant for Sterile Syringe With Safety Needle?

The FDA 510(k) record lists Jiangxi Hongda Medical Equipment Group , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Syringe With Safety Needle?

The FDA product code for Sterile Syringe With Safety Needle is MEG.

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Outros registros que listam Jiangxi Hongda Medical Equipment Group , Ltd. como candidato(a)

K210578Medical Nitrile Examination Gloves (Power free, Blue)K210821Medical PVC Examination Gloves K163160Sterile Single-use Infusion Set K163162Sterile Hypodermic Safety Syringes for Single Use K163161Sterile Single-use Syringe with Needle

Dispositivos Relacionados (Código: MEG)

K252098PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)Methyl Co., Ltd.K250847VaporShieldVault Paragon Group, Inc.K230287SaviSafe Safety DeviceSuzhou Savicred Biotechnology Co., Ltd.K231165Shina Syringe; Shina Safety SyringeShina Med Corporation K231907Medline Safety Insulin and TB SyringesMedline Industries, LP K223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)Cardinal Health200, LLC

Fonte oficial

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