510(k) K961904 ยท KOE Dilator, Urethral
AQ HYDROPHILIC DILATORS
| Applicant | Cook Urological, Inc., Spencer IN, US |
| Decision | Substantially Equivalent, Oct 18, 1996 |
| Received | May 16, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961904
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.