510(k) K954315 ยท FEN Device, Cystometric, Hydraulic
PVC ABDOMINAL/RECTAL PRESSURE CATHETER
| Applicant | Life-Tech Intl., Inc., Houston TX, US |
| Decision | Substantially Equivalent, Nov 30, 1995 |
| Received | Sep 15, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954315
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.