FDA 510(k)

Sagami Original 002 Polyurethane Male Condom

Número K: K252158 · 2026-03-30

Data da decisão2026-03-30

Código do produtoMOL

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sagami Original 002 Polyurethane Male Condom is the device name listed in this FDA 510(k) record. The listed applicant is Mayer Laboratories. It received FDA 510(k) clearance on 2026-03-30 under 510(k) number K252158. 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 Sagami Original 002 Polyurethane Male Condom?

Sagami Original 002 Polyurethane Male Condom is a medical device that received FDA 510(k) clearance on 2026-03-30. The listed applicant is Mayer Laboratories. The 510(k) number is K252158.

When did Sagami Original 002 Polyurethane Male Condom receive FDA 510(k) clearance?

Sagami Original 002 Polyurethane Male Condom received FDA 510(k) clearance on 2026-03-30, under 510(k) number K252158.

Who is the listed applicant for Sagami Original 002 Polyurethane Male Condom?

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

What is the FDA product code for Sagami Original 002 Polyurethane Male Condom?

The FDA product code for Sagami Original 002 Polyurethane Male Condom is MOL.

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Fonte oficial

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