510(k) K120127 ยท KOB Catheter, Suprapubic (And Accessories)
SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM
| Applicant | Swan Valley Medical, Incorporated, Golden CO, US |
| Decision | Substantially Equivalent, Oct 26, 2012 |
| Received | Jan 17, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120127
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.