Sagami Original 002 Polyurethane Male Condom— 510(k) K252158
Substantially EquivalentMayer Laboratories
FDA 510(k) clearance K252158 for Sagami Original 002 Polyurethane Male Condom, Substantially Equivalent on 2026-03-30. Applicant: Mayer Laboratories.
Clearance details
- Applicant
- Mayer Laboratories
- Product code
- Code MOL
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Berkeley, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.