The following data is part of a premarket notification filed by Integra Lifesciences Corp. with the FDA for Licox It2 Complete Brain Tunneling Probe Kit.
| Device ID | K053244 |
| 510k Number | K053244 |
| Device Name: | LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | INTEGRA LIFESCIENCES CORP. 311C ENTERPRISE DRIVE Plainsboro, NJ 08536 |
| Contact | Jon Caparotta |
| Correspondent | Jon Caparotta INTEGRA LIFESCIENCES CORP. 311C ENTERPRISE DRIVE Plainsboro, NJ 08536 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-21 |
| Decision Date | 2006-05-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M272IT21 | K053244 | 000 |
| M273IT21 | K053244 | 000 |