510(k) K970994 ยท EZB Stylet For Catheter, Gastro-Urology
CORE AND COIL ASSEMBLY GUIDEWIRE
| Applicant | Lake Region Mfg., Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Mar 25, 1997 |
| Received | Mar 19, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970994
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.