510(k) K961906 ยท EYZ System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10018
| Applicant | Spectrum Medsystems Corp., Irvine CA, US |
| Decision | Substantially Equivalent, Nov 19, 1996 |
| Received | May 16, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961906
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.