The following data is part of a premarket notification filed by Neuropace Inc with the FDA for Neuropace Burr Hole Cover.
| Device ID | K141368 |
| 510k Number | K141368 |
| Device Name: | NEUROPACE BURR HOLE COVER |
| Classification | Cover, Burr Hole |
| Applicant | NEUROPACE INC 455 N. BERNARDO AVE Mountain View, CA 94043 |
| Contact | Isabella R Abati |
| Correspondent | Isabella R Abati NEUROPACE INC 455 N. BERNARDO AVE Mountain View, CA 94043 |
| Product Code | GXR |
| CFR Regulation Number | 882.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-23 |
| Decision Date | 2014-07-11 |
| Summary: | summary |