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FDA 510(k)

EasyTouch Safety Pen Needle

Número K: K163578 · 2018-08-03

RequerenteMhc Medical Products, LLC
Data da decisão2018-08-03
Código do produtoFMI
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

EasyTouch Safety Pen Needle is the device name listed in this FDA 510(k) record. The listed applicant is Mhc Medical Products, LLC. It received FDA 510(k) clearance on 2018-08-03 under 510(k) number K163578. 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 EasyTouch Safety Pen Needle?

EasyTouch Safety Pen Needle is a medical device that received FDA 510(k) clearance on 2018-08-03. The listed applicant is Mhc Medical Products, LLC. The 510(k) number is K163578.

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

EasyTouch Safety Pen Needle received FDA 510(k) clearance on 2018-08-03, under 510(k) number K163578.

Who is the listed applicant for EasyTouch Safety Pen Needle?

The FDA 510(k) record lists Mhc Medical Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EasyTouch Safety Pen Needle?

The FDA product code for EasyTouch Safety 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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