510(k) K812991 ยท DTB Permanent Pacemaker Electrode
INTERMEDICS POLYFLEX-MODEL 483-04 LEAD
| Applicant | Intermedics, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Nov 16, 1981 |
| Received | Oct 26, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812991
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.