0.04 ZERO ZERO FOUR Male Latex Condom— 510(k) K243584
Substantially EquivalentOkamoto USA, Inc.
FDA 510(k) clearance K243584 for 0.04 ZERO ZERO FOUR Male Latex Condom, Substantially Equivalent on 2025-02-18. Applicant: Okamoto USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Okamoto USA, Inc.
- Product code
- Code HIS
- Device class
- Class 2
- Regulation
- 21 CFR 884.5300
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Sandusky, OH, US
Recent devices under product code HIS
view allMore clearances from Okamoto USA, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.