510(k) K243584 ยท HIS Condom
0.04 ZERO ZERO FOUR Male Latex Condom
| Applicant | Okamoto USA, Inc., Sandusky OH, US |
| Decision | Substantially Equivalent, Feb 18, 2025 |
| Received | Nov 20, 2024 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K243584
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.