510(k) K141227 ยท JXG Shunt, Central Nervous System And Components
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX
| Applicant | Sophysa SA, Mission Viejo CA, US |
| Decision | Substantially Equivalent, Apr 2, 2015 |
| Received | May 12, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141227
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.