510(k) K863365 ยท DXY Implantable Pacemaker Pulse-Generator
MODIFICATION OF STERILITY CYCLE PARAMETERS
| Applicant | Coratomic, Inc., Indiana PA, US |
| Decision | Substantially Equivalent, Oct 8, 1986 |
| Received | Sep 2, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K863365
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.