FDA 510(k)

Skyn Original Polyisoprene Lubricated Male Condom

Número K: K160399 · 2016-07-25

RequerenteAnsell Healthcare Products, LLC

Data da decisão2016-07-25

Código do produtoMOL

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Skyn Original Polyisoprene Lubricated Male Condom is the device name listed in this FDA 510(k) record. The listed applicant is Ansell Healthcare Products, LLC. It received FDA 510(k) clearance on 2016-07-25 under 510(k) number K160399. 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 Skyn Original Polyisoprene Lubricated Male Condom?

Skyn Original Polyisoprene Lubricated Male Condom is a medical device that received FDA 510(k) clearance on 2016-07-25. The listed applicant is Ansell Healthcare Products, LLC. The 510(k) number is K160399.

When did Skyn Original Polyisoprene Lubricated Male Condom receive FDA 510(k) clearance?

Skyn Original Polyisoprene Lubricated Male Condom received FDA 510(k) clearance on 2016-07-25, under 510(k) number K160399.

Who is the listed applicant for Skyn Original Polyisoprene Lubricated Male Condom?

The FDA 510(k) record lists Ansell Healthcare Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Skyn Original Polyisoprene Lubricated Male Condom?

The FDA product code for Skyn Original Polyisoprene Lubricated Male Condom is MOL.

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