Skyn Original Polyisoprene Lubricated Male Condom— 510(k) K160399
Substantially EquivalentAnsell Healthcare Products, LLC
FDA 510(k) clearance K160399 for Skyn Original Polyisoprene Lubricated Male Condom, Substantially Equivalent on 2016-07-25. Applicant: Ansell Healthcare Products, LLC.
Clearance details
- Applicant
- Ansell Healthcare Products, LLC
- Product code
- Code MOL
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Iselin, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.