FDA 510(k)

Sungshim Insulin Pen Needle

Número K: K152334 · 2016-03-17

Data da decisão2016-03-17

Código do produtoFMI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sungshim Insulin Pen Needle is the device name listed in this FDA 510(k) record. The listed applicant is Sung Shim Medicare Co., Ltd.. It received FDA 510(k) clearance on 2016-03-17 under 510(k) number K152334. 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 Sungshim Insulin Pen Needle?

Sungshim Insulin Pen Needle is a medical device that received FDA 510(k) clearance on 2016-03-17. The listed applicant is Sung Shim Medicare Co., Ltd.. The 510(k) number is K152334.

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

Sungshim Insulin Pen Needle received FDA 510(k) clearance on 2016-03-17, under 510(k) number K152334.

Who is the listed applicant for Sungshim Insulin Pen Needle?

The FDA 510(k) record lists Sung Shim Medicare Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sungshim Insulin Pen Needle?

The FDA product code for Sungshim Insulin Pen Needle is FMI.

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Outros registros que listam Sung Shim Medicare Co., Ltd. como candidato(a)

K152803SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE

Dispositivos Relacionados (Código: FMI)

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHD K261719Promisemed 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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