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FDA 510(k)

Shina Safety Needle

N.º K: K222417 · 2023-03-20

SolicitanteShina Corporation
Fecha de decisión2023-03-20
Código de productoFMI
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Shina Safety Needle is the device name listed in this FDA 510(k) record. The listed applicant is Shina Corporation. It received FDA 510(k) clearance on 2023-03-20 under 510(k) number K222417. 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 Shina Safety Needle?

Shina Safety Needle is a medical device that received FDA 510(k) clearance on 2023-03-20. The listed applicant is Shina Corporation. The 510(k) number is K222417.

When did Shina Safety Needle receive FDA 510(k) clearance?

Shina Safety Needle received FDA 510(k) clearance on 2023-03-20, under 510(k) number K222417.

Who is the listed applicant for Shina Safety Needle?

The FDA 510(k) record lists Shina Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Shina Safety Needle?

The FDA product code for Shina Safety 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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