510(k) K191684 ยท JXG Shunt, Central Nervous System And Components
MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System
| Applicant | Integra LifeSciences Corporation, Planisboro NJ, US |
| Decision | Substantially Equivalent, Oct 11, 2019 |
| Received | Jun 24, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191684
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.