510(k) K040201 ยท JXG Shunt, Central Nervous System And Components
MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM
| Applicant | Integra Neurosciences Implants S.A., Planisboro NJ, US |
| Decision | Substantially Equivalent, Feb 26, 2004 |
| Received | Jan 29, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040201
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.