510(k) K790519 ยท FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2
| Applicant | American Medical Systems, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, May 14, 1979 |
| Received | Mar 16, 1979 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K790519
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.