510(k) K013282 ยท DBY Fab, Rhodamine, Antigen, Antiserum, Control
GORE INTRODUCER SHEATH
| Applicant | W. L. Gore & Associates, Inc., Flagstaff AZ, US |
| Decision | Substantially Equivalent, Dec 14, 2001 |
| Received | Oct 2, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013282
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.