510(k) K013339 ยท DTB Permanent Pacemaker Electrode
PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS
| Applicant | Oscor, Inc., Palm Harbor FL, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Nov 8, 2001 |
| Received | Oct 9, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013339
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.