The following data is part of a premarket notification filed by Integra Neurosciences with the FDA for Monitorr Icp External Csf Drainage And Monitoring System.
| Device ID | K022554 |
| 510k Number | K022554 |
| Device Name: | MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | INTEGRA NEUROSCIENCES 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Donna Wallace |
| Correspondent | Donna Wallace INTEGRA NEUROSCIENCES 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-02 |
| Decision Date | 2002-08-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780072560 | K022554 | 000 |
| 10381780071037 | K022554 | 000 |
| 10381780070900 | K022554 | 000 |
| 10381780070894 | K022554 | 000 |
| 10381780070887 | K022554 | 000 |
| 10381780070863 | K022554 | 000 |
| 10381780070856 | K022554 | 000 |
| 10381780070849 | K022554 | 000 |
| 10381780070832 | K022554 | 000 |
| 10381780071044 | K022554 | 000 |
| 10381780071891 | K022554 | 000 |
| 10381780072157 | K022554 | 000 |
| 10381780072010 | K022554 | 000 |
| 10381780072003 | K022554 | 000 |
| 10381780071952 | K022554 | 000 |
| 10381780071945 | K022554 | 000 |
| 10381780071938 | K022554 | 000 |
| 10381780071921 | K022554 | 000 |
| 10381780071914 | K022554 | 000 |
| 10381780070825 | K022554 | 000 |