510(k) K854622 ยท HIS Condom
PROPHYLACTIC (CONDOM)
| Applicant | Medelec Intl. Corp., Miami Beach FL, US |
| Decision | Substantially Equivalent, Apr 11, 1986 |
| Received | Nov 18, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854622
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.