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FDA 510(k)

Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel

Número K: K180720 · 2018-06-27

RequerenteMedibio USA, LLC
Data da decisão2018-06-27
Código do produtoFMI
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

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 Medibio USA, LLC. It received FDA 510(k) clearance on 2018-06-27 under 510(k) number K180720. 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 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 2018-06-27. The listed applicant is Medibio USA, LLC. The 510(k) number is K180720.

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 2018-06-27, under 510(k) number K180720.

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

The FDA 510(k) record lists Medibio USA, 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.

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Dispositivos Relacionados (Código: FMI)

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