510(k) K964219 ยท EYZ System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
ZIP CONDOM CATHETER
| Applicant | Goulter Medical, Inc., Concord CA, US |
| Decision | Substantially Equivalent, Aug 11, 1997 |
| Received | Oct 22, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964219
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.