510(k) K980319 ยท HIS Condom
DUREX ULTRA COMFORT
| Applicant | London Intl., LLC, Dothan AL, US |
| Decision | Substantially Equivalent, May 20, 1998 |
| Received | Jan 27, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980319
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.