Skyn Original Polyisoprene Lubricated Male Condom— 510(k) K160399

Clearance details

Applicant

Ansell Healthcare Products, LLC

Product code

Code MOL

Device class

Class 2

Regulation

21 CFR 884.5300

Advisory panel

Obstetrics/Gynecology

Date received

2016-02-12

Decision date

2016-07-25

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Iselin, NJ, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160399.