FDA 510(k)

Seringa Hipodérmica Estéril de 1 ml para Uso Único. Com/sem Agulha. Luer/Luer-Lock

Número K: K210200 · 2021-05-14

RequerenteSet Medikal Sanayi VE Ticaret Anonim Sirketi

Data da decisão2021-05-14

Código do produtoFMF

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock is the device name listed in this FDA 510(k) record. The listed applicant is Set Medikal Sanayi VE Ticaret Anonim Sirketi. It received FDA 510(k) clearance on 2021-05-14 under 510(k) number K210200. 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 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock?

1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock is a medical device that received FDA 510(k) clearance on 2021-05-14. The listed applicant is Set Medikal Sanayi VE Ticaret Anonim Sirketi. The 510(k) number is K210200.

When did 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock receive FDA 510(k) clearance?

1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock received FDA 510(k) clearance on 2021-05-14, under 510(k) number K210200.

Who is the listed applicant for 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock?

The FDA 510(k) record lists Set Medikal Sanayi VE Ticaret Anonim Sirketi as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock?

The FDA product code for 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock is FMF.

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Outros registros que listam Set Medikal Sanayi VE Ticaret Anonim Sirketi como candidato(a)

K201284Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use

Dispositivos Relacionados (Código: FMF)

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC K252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLC K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

Fonte oficial

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