The following data is part of a premarket notification filed by Integra Neurosciences with the FDA for Auragen Cortical Surface Electrodes.
| Device ID | K082250 |
| 510k Number | K082250 |
| Device Name: | AURAGEN CORTICAL SURFACE ELECTRODES |
| Classification | Electrode, Cortical |
| Applicant | INTEGRA NEUROSCIENCES 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Jon Caparotta |
| Correspondent | Jon Caparotta INTEGRA NEUROSCIENCES 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Product Code | GYC |
| CFR Regulation Number | 882.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-08 |
| Decision Date | 2008-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M27240M411 | K082250 | 000 |
| M27240M711 | K082250 | 000 |
| M27240M731 | K082250 | 000 |
| M27240M741 | K082250 | 000 |
| M27240M751 | K082250 | 000 |
| M27240M761 | K082250 | 000 |
| M27240M771 | K082250 | 000 |
| M27240M781 | K082250 | 000 |
| M27240M811 | K082250 | 000 |
| M27240M851 | K082250 | 000 |
| M27240M861 | K082250 | 000 |
| M272AU1X10P1 | K082250 | 000 |
| M272AU1X12P1 | K082250 | 000 |
| M272AU1X2P1 | K082250 | 000 |
| M272AU1X4P1 | K082250 | 000 |
| M272AU1X4PD1 | K082250 | 000 |
| M272AU1X4PM1501 | K082250 | 000 |
| M272AU1X4PN1 | K082250 | 000 |
| M27240M701 | K082250 | 000 |
| M27240M691 | K082250 | 000 |
| M27240M681 | K082250 | 000 |
| M27240M421 | K082250 | 000 |
| M27240M431 | K082250 | 000 |
| M27240M451 | K082250 | 000 |
| M27240M461 | K082250 | 000 |
| M27240M471 | K082250 | 000 |
| M27240M481 | K082250 | 000 |
| M27240M491 | K082250 | 000 |
| M27240M501 | K082250 | 000 |
| M27240M521 | K082250 | 000 |
| M27240M531 | K082250 | 000 |
| M27240M541 | K082250 | 000 |
| M27240M591 | K082250 | 000 |
| M27240M601 | K082250 | 000 |
| M27240M621 | K082250 | 000 |
| M27240M631 | K082250 | 000 |
| M27240M661 | K082250 | 000 |
| M27240M671 | K082250 | 000 |
| M272AU1X6P1 | K082250 | 000 |
| M272AU1X6PD1 | K082250 | 000 |
| M272AU1X6PM751 | K082250 | 000 |
| M272AU6X6P3S1 | K082250 | 000 |
| M272AU6X8P31 | K082250 | 000 |
| M272AU6X8P61 | K082250 | 000 |
| M272AU8X1P1 | K082250 | 000 |
| M272AU8X2P2C1 | K082250 | 000 |
| M272AU8X2P2CDL1 | K082250 | 000 |
| M272AU8X2P4CD1 | K082250 | 000 |
| M272AU8X4P141 | K082250 | 000 |
| M272AU8X8P14M41 | K082250 | 000 |
| M272AU8X8P14M751 | K082250 | 000 |
| M272AU8X8P14S1 | K082250 | 000 |
| M272AU8X8P14SV1 | K082250 | 000 |
| M272AU8X8P41 | K082250 | 000 |
| M272AU8X8P4M41 | K082250 | 000 |
| M272AU8X8P4M751 | K082250 | 000 |
| M272AU8X8P4S1 | K082250 | 000 |
| M272AU8X8P4V1 | K082250 | 000 |
| M272AU6X2P2CD1 | K082250 | 000 |
| M272AU6X2P1C1 | K082250 | 000 |
| M272AU5X8P151 | K082250 | 000 |
| M272AU1X6PN1 | K082250 | 000 |
| M272AU1X8P1 | K082250 | 000 |
| M272AU1X8PD21 | K082250 | 000 |
| M272AU1X8PN1 | K082250 | 000 |
| M272AU2X4P11 | K082250 | 000 |
| M272AU2X6P11 | K082250 | 000 |
| M272AU2X8P11 | K082250 | 000 |
| M272AU2X8P21 | K082250 | 000 |
| M272AU4X2P1C1 | K082250 | 000 |
| M272AU4X2P2CD1 | K082250 | 000 |
| M272AU4X4P11 | K082250 | 000 |
| M272AU4X5P121 | K082250 | 000 |
| M272AU4X5P21 | K082250 | 000 |
| M272AU4X6P21 | K082250 | 000 |
| M272AU4X8P121 | K082250 | 000 |
| M272AU4X8P21 | K082250 | 000 |
| M272AU4X8P41 | K082250 | 000 |
| M272AU8X8P81 | K082250 | 000 |