510(k) K900760 ยท KOE Dilator, Urethral
AMS OPTILUME INFLATION SYRINGE
| Applicant | American Medical Systems, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, May 17, 1990 |
| Received | Feb 16, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K900760
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.