510(k) K834347 ยท FAE Prosthesis, Penile
FLEXI-FLATE PENILE IMPLANT
| Applicant | Surgitek, Walker MI, US |
| Decision | Substantially Equivalent, Apr 2, 1984 |
| Received | Dec 13, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K834347
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.