510(k) K830048 ยท FAE Prosthesis, Penile
INFLATABLE PENILE PROSTH. - CYLINDER
| Applicant | American Medical Systems, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 12, 1983 |
| Received | Jan 10, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K830048
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.