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. Device class: 2.
Clearance details
- Applicant
- Mayer Laboratories
- Product code
- Code MOL
- Device class
- Class 2
- Regulation
- 21 CFR 884.5300
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Berkeley, CA, US
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