The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Duragen Secure Dural Regeneration Matrix.
| Device ID | K163456 |
| 510k Number | K163456 |
| Device Name: | DuraGen Secure Dural Regeneration Matrix |
| Classification | Dura Substitute |
| Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DRIVE Plainsboro, NJ 08536 |
| Contact | Yara Hamid |
| Correspondent | Yara Hamid INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DRIVE Plainsboro, NJ 08536 |
| Product Code | GXQ |
| CFR Regulation Number | 882.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-09 |
| Decision Date | 2017-01-06 |
| Summary: | summary |