Synthetic Polyisoprene Lubricated Male Condom - 5 senses— 510(k) K182438
Substantially EquivalentSxwell USA, LLC
FDA 510(k) clearance K182438 for Synthetic Polyisoprene Lubricated Male Condom - 5 senses, Substantially Equivalent on 2018-12-06. Applicant: Sxwell USA, LLC.
Clearance details
- Applicant
- Sxwell USA, 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.