510(k) K803111 ยท FAE Prosthesis, Penile
ERECTAID
| Applicant | Burditt & Calkins-Siemens-Elema, Chicago IL, US |
| Decision | Substantially Equivalent, Jan 23, 1981 |
| Received | Dec 10, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K803111
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.