K240379
- 510(k) number
- K240379
- Device name
- TROJAN SIS Synthetic Latex Condom with Silicone Lubricant
- Applicant
- Church & Dwight Co., Inc. NJ · US
- Product code
- MOL — Condom, Synthetic
- Decision date
- 2024-10-08
- Date received
- 2024-02-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K240379.pdf
Official FDA record: K240379
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.