510(k) K971257 ยท LKY Device, External Penile Rigidity
VTU-1 VACUUM ERECTION SYSTEM
| Applicant | Mckenna & Cuneo, Washington DC, US |
| Decision | Substantially Equivalent, Oct 3, 1997 |
| Received | Apr 4, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971257
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.