510(k) K905015 ยท LKY Device, External Penile Rigidity
SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE
| Applicant | Surgitek, Racine WI, US |
| Decision | Substantially Equivalent, Dec 28, 1990 |
| Received | Nov 7, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905015
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.