510(k) K861468 ยท LKY Device, External Penile Rigidity
IMPAX, MALE IMPOTENCE AID
| Applicant | Lehigh Group, Concord MA, US |
| Decision | Substantially Equivalent, Jun 18, 1986 |
| Received | Apr 21, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861468
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.