510(k) K831660 ยท FAE Prosthesis, Penile
AMS MALLEABLE PENILE PROSTHESIS
| Applicant | American Medical Systems, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Aug 8, 1983 |
| Received | May 23, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831660
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.