510(k) K942191 ยท DYB Introducer, Catheter
URESIL DILATOR
| Applicant | Uresil Corp., Skokie IL, US |
| Decision | Substantially Equivalent, Sep 21, 1994 |
| Received | May 4, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K942191
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.