510(k) K912344 ยท FAE Prosthesis, Penile
MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS
| Applicant | Dacomed Corp., Minneapolis MN, US |
| Decision | Substantially Equivalent, Oct 11, 1991 |
| Received | May 28, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912344
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.