FDA 510(k)

Retraction, CWM-910T, APOLEX Tite

Número K: K222709 · 2023-03-21

Data da decisão2023-03-21

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Retraction, CWM-910T, APOLEX Tite is the device name listed in this FDA 510(k) record. The listed applicant is Chungwoo Co., Ltd.. It received FDA 510(k) clearance on 2023-03-21 under 510(k) number K222709. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Retraction, CWM-910T, APOLEX Tite?

Retraction, CWM-910T, APOLEX Tite is a medical device that received FDA 510(k) clearance on 2023-03-21. The listed applicant is Chungwoo Co., Ltd.. The 510(k) number is K222709.

When did Retraction, CWM-910T, APOLEX Tite receive FDA 510(k) clearance?

Retraction, CWM-910T, APOLEX Tite received FDA 510(k) clearance on 2023-03-21, under 510(k) number K222709.

Who is the listed applicant for Retraction, CWM-910T, APOLEX Tite?

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

What is the FDA product code for Retraction, CWM-910T, APOLEX Tite?

The FDA product code for Retraction, CWM-910T, APOLEX Tite is GEI.

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Fonte oficial

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