510(k) K823371 ยท DXY Implantable Pacemaker Pulse-Generator
DURAPULSE
| Applicant | Cpm International, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Dec 22, 1982 |
| Received | Nov 12, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K823371
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.