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FDA 510(k)

Injection Pen Needle

N.º K: K192464 · 2020-08-25

SolicitanteGangan Medical Technology Jiangsu Co., Ltd.
Fecha de decisión2020-08-25
Código de productoFMI
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Injection Pen Needle is the device name listed in this FDA 510(k) record. The listed applicant is Gangan Medical Technology Jiangsu Co., Ltd.. It received FDA 510(k) clearance on 2020-08-25 under 510(k) number K192464. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Injection Pen Needle?

Injection Pen Needle is a medical device that received FDA 510(k) clearance on 2020-08-25. The listed applicant is Gangan Medical Technology Jiangsu Co., Ltd.. The 510(k) number is K192464.

When did Injection Pen Needle receive FDA 510(k) clearance?

Injection Pen Needle received FDA 510(k) clearance on 2020-08-25, under 510(k) number K192464.

Who is the listed applicant for Injection Pen Needle?

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

What is the FDA product code for Injection Pen Needle?

The FDA product code for Injection Pen Needle is FMI.

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Dispositivos relacionados (Código: FMI)

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.

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHDK261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.

Fuente oficial

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