FDA 510(k)

Carex Hybrid Personal Lubricant

Número K: K223519 · 2023-08-11

Data da decisão2023-08-11

Código do produtoNUC

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Carex Hybrid Personal Lubricant is the device name listed in this FDA 510(k) record. The listed applicant is Karex Industries Sdn. Bhd.. It received FDA 510(k) clearance on 2023-08-11 under 510(k) number K223519. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Carex Hybrid Personal Lubricant?

Carex Hybrid Personal Lubricant is a medical device that received FDA 510(k) clearance on 2023-08-11. The listed applicant is Karex Industries Sdn. Bhd.. The 510(k) number is K223519.

When did Carex Hybrid Personal Lubricant receive FDA 510(k) clearance?

Carex Hybrid Personal Lubricant received FDA 510(k) clearance on 2023-08-11, under 510(k) number K223519.

Who is the listed applicant for Carex Hybrid Personal Lubricant?

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

What is the FDA product code for Carex Hybrid Personal Lubricant?

The FDA product code for Carex Hybrid Personal Lubricant is NUC.

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