510(k) K912736 ยท LKY Device, External Penile Rigidity
ERECAID(R) SYSTEM PLUS
| Applicant | Osbon Medical Systems, Ltd., Augusta GA, US |
| Decision | Substantially Equivalent, Aug 12, 1991 |
| Received | Jun 21, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912736
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.