510(k) K904434 ยท KOB Catheter, Suprapubic (And Accessories)
SEXTON CYSTOTOMY URINE PUMP (SCUP2)
| Applicant | Phoenix Bioengineering, Inc., Bridgeport PA, US |
| Decision | Substantially Equivalent, Feb 1, 1991 |
| Received | Sep 28, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904434
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.