510(k) K853206 ยท DXY Implantable Pacemaker Pulse-Generator
IMPLANT PROGRAM CARDIAC PULSE GEN W/MOD SET SCREW
| Applicant | Telectronics, Inc., Suffield CT, US |
| Decision | Substantially Equivalent, Sep 12, 1985 |
| Received | Jul 31, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853206
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.