510(k) K042481 ยท JXG Shunt, Central Nervous System And Components
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400
| Applicant | Sophysa SA, Wellesley MA, US |
| Decision | Substantially Equivalent, Dec 14, 2004 |
| Received | Sep 13, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042481
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.