510(k) K790100 ยท DXY Implantable Pacemaker Pulse-Generator
ISOLATION SLEEVE, MODEL 348-01
| Applicant | Intermedics, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jan 24, 1979 |
| Received | Jan 16, 1979 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K790100
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.