510(k) K920451 ยท FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
ENDOTEK ULTRA SYSTEM
| Applicant | Surgitek, Racine WI, US |
| Decision | Substantially Equivalent, Sep 17, 1992 |
| Received | Feb 4, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K920451
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.