510(k) K152897 ยท JXG Shunt, Central Nervous System And Components
Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory
| Applicant | Integra LifeSciences Corporation, Planisboro NJ, US |
| Decision | Substantially Equivalent, Mar 4, 2016 |
| Received | Oct 1, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152897
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.