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FDA 510(k)

Injection Pen Needle

Número K: K192464 · 2020-08-25

RequerenteGangan Medical Technology Jiangsu Co., Ltd.
Data da decisão2020-08-25
Código do produtoFMI
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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.

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