510(k) K953353 ยท FEN Device, Cystometric, Hydraulic
UROVISION JANUS
| Applicant | Life-Tech Intl., Inc., Houston TX, US |
| Decision | Substantially Equivalent, Sep 8, 1995 |
| Received | Jul 17, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953353
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.