510(k) K013488 ยท JXG Shunt, Central Nervous System And Components
SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8
| Applicant | Sophysa SA, Wellesley MA, US |
| Decision | Substantially Equivalent, Mar 27, 2002 |
| Received | Oct 19, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013488
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.