FDA 510(k)

Unifine Pentips/ Unifine Pentips Plus

Número K: K152339 · 2016-06-24

Data da decisão2016-06-24

Código do produtoFMI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Unifine Pentips/ Unifine Pentips Plus is the device name listed in this FDA 510(k) record. The listed applicant is Owen Mumford, Ltd.. It received FDA 510(k) clearance on 2016-06-24 under 510(k) number K152339. 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 Unifine Pentips/ Unifine Pentips Plus?

Unifine Pentips/ Unifine Pentips Plus is a medical device that received FDA 510(k) clearance on 2016-06-24. The listed applicant is Owen Mumford, Ltd.. The 510(k) number is K152339.

When did Unifine Pentips/ Unifine Pentips Plus receive FDA 510(k) clearance?

Unifine Pentips/ Unifine Pentips Plus received FDA 510(k) clearance on 2016-06-24, under 510(k) number K152339.

Who is the listed applicant for Unifine Pentips/ Unifine Pentips Plus?

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

What is the FDA product code for Unifine Pentips/ Unifine Pentips Plus?

The FDA product code for Unifine Pentips/ Unifine Pentips Plus is FMI.

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