510(k) K920551 ยท KOE Dilator, Urethral
120 FR OPTILUME PROSTATE BALLOON DILATOR
| Applicant | American Medical Systems, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Oct 28, 1992 |
| Received | Feb 6, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K920551
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.