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FDA 510(k)

Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches

Número K: K193325 · 2020-03-13

RequerenteProsys International, Ltd.
Data da decisão2020-03-13
Código do produtoKNT
Comité consultivoGU
DecisãoSubstantially Equivalent

Resumo do dispositivo

Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches is the device name listed in this FDA 510(k) record. The listed applicant is Prosys International, Ltd.. It received FDA 510(k) clearance on 2020-03-13 under 510(k) number K193325. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches?

Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches is a medical device that received FDA 510(k) clearance on 2020-03-13. The listed applicant is Prosys International, Ltd.. The 510(k) number is K193325.

When did Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches receive FDA 510(k) clearance?

Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches received FDA 510(k) clearance on 2020-03-13, under 510(k) number K193325.

Who is the listed applicant for Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches?

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

What is the FDA product code for Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches?

The FDA product code for Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches is KNT.

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