510(k) K920420 ยท FAE Prosthesis, Penile
DURA II PENILE PROSTHESIS
| Applicant | Dacomed Corp., Minneapolis MN, US |
| Decision | Substantially Equivalent, Apr 16, 1992 |
| Received | Jan 31, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K920420
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.