The following data is part of a premarket notification filed by Medtronic Neurosurgery with the FDA for Durepair Dura Regeneration Matrix.
| Device ID | K041000 |
| 510k Number | K041000 |
| Device Name: | DUREPAIR DURA REGENERATION MATRIX |
| Classification | Dura Substitute |
| Applicant | MEDTRONIC NEUROSURGERY 125 CREMONA DR., Goleta, CA 93117 |
| Contact | Jeffrey Henderson |
| Correspondent | Jeffrey Henderson MEDTRONIC NEUROSURGERY 125 CREMONA DR., Goleta, CA 93117 |
| Product Code | GXQ |
| CFR Regulation Number | 882.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-19 |
| Decision Date | 2004-07-27 |
| Summary: | summary |