510(k) K833628 ยท FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
LUMEN-4 URODYNAMIC CATHETER
| Applicant | Surgitek, Mchenry IL, US |
| Decision | Substantially Equivalent, Nov 28, 1983 |
| Received | Oct 14, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K833628
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.