510(k) K980282 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
URESIL DILATOR WITH RADIOPAQUE MARKER
| Applicant | Uresil Corp., Skokie IL, US |
| Decision | Substantially Equivalent, Apr 24, 1998 |
| Received | Jan 26, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980282
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.