510(k) K161992 ยท JXG Shunt, Central Nervous System And Components
Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems
| Applicant | Integra LifeSciences Corporation, Planisboro NJ, US |
| Decision | Substantially Equivalent, Sep 22, 2016 |
| Received | Jul 19, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161992
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.