510(k) K983438 ยท LKY Device, External Penile Rigidity
MAX IT
| Applicant | Dorea, Inc., Cairo GA, US |
| Decision | Substantially Equivalent, Feb 8, 1999 |
| Received | Sep 29, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983438
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.