FDA 510(k)

Sterile Hypodermic Needle for Single Use

K-Nummer: K180259 · 2018-05-18

AntragstellerJiangsu Shenli Medical Production Co., Ltd.

Entscheidungsdatum2018-05-18

ProduktcodeFMI

BeratungsausschussHO

EntscheidungSubstantially Equivalent

Produktübersicht

Sterile Hypodermic Needle for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Shenli Medical Production Co., Ltd.. It received FDA 510(k) clearance on 2018-05-18 under 510(k) number K180259. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Sterile Hypodermic Needle for Single Use?

Sterile Hypodermic Needle for Single Use is a medical device that received FDA 510(k) clearance on 2018-05-18. The listed applicant is Jiangsu Shenli Medical Production Co., Ltd.. The 510(k) number is K180259.

When did Sterile Hypodermic Needle for Single Use receive FDA 510(k) clearance?

Sterile Hypodermic Needle for Single Use received FDA 510(k) clearance on 2018-05-18, under 510(k) number K180259.

Who is the listed applicant for Sterile Hypodermic Needle for Single Use?

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

What is the FDA product code for Sterile Hypodermic Needle for Single Use?

The FDA product code for Sterile Hypodermic Needle for Single Use is FMI.

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Verwandte Geräte (Code: 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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