510(k) K092395 ยท JXG Shunt, Central Nervous System And Components
OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM
| Applicant | Integra Lifesciences Corp., Planisboro NJ, US |
| Decision | Substantially Equivalent, Nov 19, 2009 |
| Received | Aug 5, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092395
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.