510(k) K243421 ยท HIS Condom
Lelo Hex Lubricated Natural Rubber Latex Condom
| Applicant | Lelo, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Mar 7, 2025 |
| Received | Nov 4, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243421
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.