K231908
- 510(k) number
- K231908
- Device name
- 45 Micron Polyisoprene Condom
- Applicant
- Suretex Limited TH
- Product code
- MOL — Condom, Synthetic
- Decision date
- 2023-10-27
- Date received
- 2023-06-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K231908.pdf
Official FDA record: K231908
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.