FDA 510(k)

Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel

Numéro K : K171144 · 2017-09-12

Date de décision2017-09-12

Code produitFMI

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel is the device name listed in this FDA 510(k) record. The listed applicant is Medbio, LLC. It received FDA 510(k) clearance on 2017-09-12 under 510(k) number K171144. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel?

Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel is a medical device that received FDA 510(k) clearance on 2017-09-12. The listed applicant is Medbio, LLC. The 510(k) number is K171144.

When did Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel receive FDA 510(k) clearance?

Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel received FDA 510(k) clearance on 2017-09-12, under 510(k) number K171144.

Who is the listed applicant for Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel?

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

What is the FDA product code for Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel?

The FDA product code for Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel is FMI.

Essais cliniques associés

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Dispositifs connexes (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.

Source officielle

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