Okamoto 002 Lubricated Polyurethane Male Condom— 510(k) K203541
Substantially EquivalentOkamoto USA, Inc.
FDA 510(k) clearance K203541 for Okamoto 002 Lubricated Polyurethane Male Condom, Substantially Equivalent on 2022-02-25. Applicant: Okamoto USA, Inc..
Clearance details
- Applicant
- Okamoto USA, Inc.
- Product code
- Code MOL
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stratford, CT, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.