510(k) K972428 ยท HIS Condom
EXTRAWEAR, GENTLEMEN'S CHOICE
| Applicant | Custom Services Intl., Inc., Las Vegas NV, US |
| Decision | Substantially Equivalent, Aug 25, 1997 |
| Received | Jun 27, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972428
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.