510(k) K963328 ยท FAE Prosthesis, Penile
AMS AMBICOR PENILE PROSTHESIS
| Applicant | American Medical Systems, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Dec 4, 1996 |
| Received | Aug 23, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963328
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.