510(k) K821627 ยท FAG Prosthesis, Urethral Sphincter
THE ARTIFICIAL URINARY SPHINCTER
| Applicant | American Medical Systems, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Aug 10, 1982 |
| Received | Jun 2, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K821627
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.