510(k) K821628 ยท FAE Prosthesis, Penile
THE INFLATABLE PENILE PROSTHESIS
| Applicant | American Medical Systems, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Aug 10, 1982 |
| Received | Jun 2, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K821628
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.