510(k) K800645 ยท DXY Implantable Pacemaker Pulse-Generator
CYBERLITH IMPLANTABLE PULSE GEN. #253-04
| Applicant | Intermedics, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 8, 1980 |
| Received | Mar 24, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K800645
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.