The following data is part of a premarket notification filed by Neuropace Inc with the FDA for Neuropace Burr Hole Cover Model 8110.
| Device ID | K123163 |
| 510k Number | K123163 |
| Device Name: | NEUROPACE BURR HOLE COVER MODEL 8110 |
| Classification | Cover, Burr Hole |
| Applicant | NEUROPACE INC 455 N. BERNARDO AVE Mountain View, CA 94043 |
| Contact | Isabella Abati |
| Correspondent | Isabella Abati NEUROPACE INC 455 N. BERNARDO AVE Mountain View, CA 94043 |
| Product Code | GXR |
| CFR Regulation Number | 882.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-09 |
| Decision Date | 2013-01-18 |
| Summary: | summary |