510(k) K153041 ยท JXG Shunt, Central Nervous System And Components
Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling
| Applicant | Integra LifeSciences Corporation, Planisboro NJ, US |
| Decision | Substantially Equivalent, Mar 14, 2016 |
| Received | Oct 19, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153041
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.