FDA 510(k)

Skyn Original Polyisoprene Lubricated Male Condom - Flavored

Numéro K : K171172 · 2017-08-02

DemandeurAnsell Healthcare Products, LLC

Date de décision2017-08-02

Code produitMOL

Comité consultatifOB

DécisionSubstantially Equivalent

Résumé du dispositif

Skyn Original Polyisoprene Lubricated Male Condom - Flavored 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 2017-08-02 under 510(k) number K171172. The device is classified under product code MOL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Skyn Original Polyisoprene Lubricated Male Condom - Flavored?

Skyn Original Polyisoprene Lubricated Male Condom - Flavored is a medical device that received FDA 510(k) clearance on 2017-08-02. The listed applicant is Ansell Healthcare Products, LLC. The 510(k) number is K171172.

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

Skyn Original Polyisoprene Lubricated Male Condom - Flavored received FDA 510(k) clearance on 2017-08-02, under 510(k) number K171172.

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

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 - Flavored?

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

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Source officielle

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