K243584
- 510(k) number
- K243584
- Device name
- 0.04 ZERO ZERO FOUR Male Latex Condom
- Applicant
- Okamoto USA, Inc. OH · US
- Product code
- HIS — Condom
- Decision date
- 2025-02-18
- Date received
- 2024-11-20
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K243584.pdf
Official FDA record: K243584
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.