510(k) K853034 ยท DXY Implantable Pacemaker Pulse-Generator
#335-01 SILIC RUB ISOLA SLEEVE FOR INT #281-03 SIZ
| Applicant | Intermedics, Inc., Freeport TX, US |
| Decision | Substantially Equivalent, Jul 25, 1985 |
| Received | Jul 18, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853034
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.