510(k) K970578 ยท JXG Shunt, Central Nervous System And Components
RADIONICS BURR HOLE VALVE
| Applicant | Radionics, Inc., Burlington MA, US |
| Decision | Substantially Equivalent, Jun 4, 1997 |
| Received | Feb 14, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970578
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.