510(k) K912935 ยท FAE Prosthesis, Penile
AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS
| Applicant | American Medical Systems, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Mar 18, 1992 |
| Received | Jul 5, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912935
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.