510(k) K031097 ยท JXG Shunt, Central Nervous System And Components
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB
| Applicant | Sophysa SA, Wellesley MA, US |
| Decision | Substantially Equivalent, Feb 26, 2004 |
| Received | Apr 7, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031097
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.