510(k) K920711 ยท KOE Dilator, Urethral
ENTRAC URETHRAL BALLOON DILATATION CATHETER
| Applicant | American Medical Systems, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, May 6, 1992 |
| Received | Feb 18, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K920711
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.