510(k) K833198 ยท DXY Implantable Pacemaker Pulse-Generator
SILICONE RUBBER ISOLATION SLEEVE 351-01
| Applicant | Intermedics, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Oct 27, 1983 |
| Received | Sep 19, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K833198
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.