510(k) K082006 ยท FAE Prosthesis, Penile
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
| Applicant | American Medical Systems, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Oct 20, 2008 |
| Received | Jul 15, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082006
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.