510(k) K951443 ยท FCN Urinary Drainage Collection Kit, For Indwelling Catheter
STANDARD FOLEY SYSTEM PAK
| Applicant | Trinity Laboratories, Inc., Salisbury MD, US |
| Decision | Substantially Equivalent, Jun 15, 1995 |
| Received | Mar 29, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951443
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.