FDA 510(k)

Okamoto 002 Lubricated Polyurethane Male Condom

Número K: K203541 · 2022-02-25

Data da decisão2022-02-25

Código do produtoMOL

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Okamoto 002 Lubricated Polyurethane Male Condom is the device name listed in this FDA 510(k) record. The listed applicant is Okamoto USA, Inc.. It received FDA 510(k) clearance on 2022-02-25 under 510(k) number K203541. The device is classified under product code MOL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Okamoto 002 Lubricated Polyurethane Male Condom?

Okamoto 002 Lubricated Polyurethane Male Condom is a medical device that received FDA 510(k) clearance on 2022-02-25. The listed applicant is Okamoto USA, Inc.. The 510(k) number is K203541.

When did Okamoto 002 Lubricated Polyurethane Male Condom receive FDA 510(k) clearance?

Okamoto 002 Lubricated Polyurethane Male Condom received FDA 510(k) clearance on 2022-02-25, under 510(k) number K203541.

Who is the listed applicant for Okamoto 002 Lubricated Polyurethane Male Condom?

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

What is the FDA product code for Okamoto 002 Lubricated Polyurethane Male Condom?

The FDA product code for Okamoto 002 Lubricated Polyurethane Male Condom is MOL.

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Fonte oficial

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