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FDA 510(k)

Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle

N.º K: K221308 · 2022-10-17

SolicitanteJiangxi Maidikang Medical Devices Co., Ltd.
Fecha de decisión2022-10-17
Código de productoFMF
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Maidikang Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2022-10-17 under 510(k) number K221308. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle?

Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle is a medical device that received FDA 510(k) clearance on 2022-10-17. The listed applicant is Jiangxi Maidikang Medical Devices Co., Ltd.. The 510(k) number is K221308.

When did Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle receive FDA 510(k) clearance?

Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle received FDA 510(k) clearance on 2022-10-17, under 510(k) number K221308.

Who is the listed applicant for Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle?

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

What is the FDA product code for Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle?

The FDA product code for Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle is FMF.

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Dispositivos relacionados (Código: FMF)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-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, LLCK253110Sol-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.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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