510(k) K090342 ยท JXG Shunt, Central Nervous System And Components
POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400
| Applicant | Sophysa SA, Dana Point CA, US |
| Decision | Substantially Equivalent, Aug 11, 2009 |
| Received | Feb 10, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090342
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.