The following data is part of a premarket notification filed by Integra Neurosciences with the FDA for Licox Cc1.g2 Brain Oxygen Catheter-microprobe.
| Device ID | K020558 |
| 510k Number | K020558 |
| Device Name: | LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | INTEGRA NEUROSCIENCES 5955 PACIFIC CENTER BLVD. San Diego, CA 92121 |
| Contact | Nancy Mathewson |
| Correspondent | Nancy Mathewson INTEGRA NEUROSCIENCES 5955 PACIFIC CENTER BLVD. San Diego, CA 92121 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-20 |
| Decision Date | 2002-03-21 |
| Summary: | summary |