510(k) K910214 ยท FAE Prosthesis, Penile
AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS
| Applicant | American Medical Corp., Minnetonka MN, US |
| Decision | Substantially Equivalent, Apr 25, 1991 |
| Received | Jan 17, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910214
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.