510(k) K930135 ยท FEN Device, Cystometric, Hydraulic
SILICONE RECTAL BALLOON
| Applicant | Cook Urological, Inc., Spencer IN, US |
| Decision | Substantially Equivalent, Oct 8, 1993 |
| Received | Jan 12, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K930135
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.