FDA 510(k)

R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose

Número K: K192913 · 2021-01-19

RequerenteImicryl Dis Malzemeleri Sanayi VE Ticaret AS

Data da decisão2021-01-19

Código do produtoKLE

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose is the device name listed in this FDA 510(k) record. The listed applicant is Imicryl Dis Malzemeleri Sanayi VE Ticaret AS. It received FDA 510(k) clearance on 2021-01-19 under 510(k) number K192913. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose?

R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose is a medical device that received FDA 510(k) clearance on 2021-01-19. The listed applicant is Imicryl Dis Malzemeleri Sanayi VE Ticaret AS. The 510(k) number is K192913.

When did R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose receive FDA 510(k) clearance?

R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose received FDA 510(k) clearance on 2021-01-19, under 510(k) number K192913.

Who is the listed applicant for R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose?

The FDA 510(k) record lists Imicryl Dis Malzemeleri Sanayi VE Ticaret AS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose?

The FDA product code for R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose is KLE.

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