510(k) K850019 ยท FAE Prosthesis, Penile
OMNI PHASE PENILE PROSTHESIS
| Applicant | Dacomed Corp., Minneapolis MN, US |
| Decision | Substantially Equivalent, Apr 9, 1985 |
| Received | Jan 3, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850019
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.