The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Integra Electrode Tunneling Needle.
| Device ID | K102802 |
| 510k Number | K102802 |
| Device Name: | INTEGRA ELECTRODE TUNNELING NEEDLE |
| Classification | Electrode, Cortical |
| Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Derek Cao |
| Correspondent | Derek Cao INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Product Code | GYC |
| CFR Regulation Number | 882.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-27 |
| Decision Date | 2010-11-23 |
| Summary: | summary |