FDA 510(k)

TK Sterile Hypodermic Needle

N.º K: K191643 · 2019-12-19

SolicitanteAnhui Tiankang Medical Technology Co., Ltd.

Fecha de decisión2019-12-19

Código de productoFMI

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

TK Sterile Hypodermic Needle is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Tiankang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-12-19 under 510(k) number K191643. 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 TK Sterile Hypodermic Needle?

TK Sterile Hypodermic Needle is a medical device that received FDA 510(k) clearance on 2019-12-19. The listed applicant is Anhui Tiankang Medical Technology Co., Ltd.. The 510(k) number is K191643.

When did TK Sterile Hypodermic Needle receive FDA 510(k) clearance?

TK Sterile Hypodermic Needle received FDA 510(k) clearance on 2019-12-19, under 510(k) number K191643.

Who is the listed applicant for TK Sterile Hypodermic Needle?

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

What is the FDA product code for TK Sterile Hypodermic Needle?

The FDA product code for TK Sterile Hypodermic Needle is FMI.

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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.

Fuente oficial

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