FDA 510(k)

Colonic Plus Regular, Small, and Straight Shape Hydrokit

Número K: K180800 · 2018-06-01

Data da decisão2018-06-01

Código do produtoKPL

Comité consultivoGU

DecisãoUnknown

Resumo do dispositivo

Colonic Plus Regular, Small, and Straight Shape Hydrokit is the device name listed in this FDA 510(k) record. The listed applicant is Colonic Plus. It received FDA 510(k) clearance on 2018-06-01 under 510(k) number K180800. The device is classified under product code KPL. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Perguntas frequentes

What is the Colonic Plus Regular, Small, and Straight Shape Hydrokit?

Colonic Plus Regular, Small, and Straight Shape Hydrokit is a medical device that received FDA 510(k) clearance on 2018-06-01. The listed applicant is Colonic Plus. The 510(k) number is K180800.

When did Colonic Plus Regular, Small, and Straight Shape Hydrokit receive FDA 510(k) clearance?

Colonic Plus Regular, Small, and Straight Shape Hydrokit received FDA 510(k) clearance on 2018-06-01, under 510(k) number K180800.

Who is the listed applicant for Colonic Plus Regular, Small, and Straight Shape Hydrokit?

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

What is the FDA product code for Colonic Plus Regular, Small, and Straight Shape Hydrokit?

The FDA product code for Colonic Plus Regular, Small, and Straight Shape Hydrokit is KPL.

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Fonte oficial

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