510(k) K970658 ยท JXG Shunt, Central Nervous System And Components
LUMBAR DRAINAGE ACCESSORY KIT
| Applicant | Integra Neurocare, LLC, Pleasant Prairie WI, US |
| Decision | Substantially Equivalent, May 19, 1997 |
| Received | Feb 21, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970658
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.