The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Monitorr Icp External Drainage And Monitoring System, Limitorr Volume Limiting External Csf Drainage System.
| Device ID | K191684 |
| 510k Number | K191684 |
| Device Name: | MoniTorr ICP External Drainage And Monitoring System, LimiTorr Volume Limiting External CSF Drainage System |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | Integra Lifesciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 |
| Contact | Omayra Ramirez |
| Correspondent | Omayra Ramirez Integra Lifesciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-24 |
| Decision Date | 2019-10-11 |
| Summary: | summary |