FDA 510(k)

K2M Fenestrated Tap System

Número K: K152872 · 2016-01-05

RequerenteK2m

Data da decisão2016-01-05

Código do produtoKNW

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

K2M Fenestrated Tap System is the device name listed in this FDA 510(k) record. The listed applicant is K2m. It received FDA 510(k) clearance on 2016-01-05 under 510(k) number K152872. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the K2M Fenestrated Tap System?

K2M Fenestrated Tap System is a medical device that received FDA 510(k) clearance on 2016-01-05. The listed applicant is K2m. The 510(k) number is K152872.

When did K2M Fenestrated Tap System receive FDA 510(k) clearance?

K2M Fenestrated Tap System received FDA 510(k) clearance on 2016-01-05, under 510(k) number K152872.

Who is the listed applicant for K2M Fenestrated Tap System?

The FDA 510(k) record lists K2m as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K2M Fenestrated Tap System?

The FDA product code for K2M Fenestrated Tap System is KNW.

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Fonte oficial

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