The following data is part of a premarket notification filed by Integra Lifesciences with the FDA for Duragen Secure Dural Regneration Matrix.
| Device ID | K120600 |
| 510k Number | K120600 |
| Device Name: | DURAGEN SECURE DURAL REGNERATION MATRIX |
| Classification | Dura Substitute |
| Applicant | INTEGRA LIFESCIENCES 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Aakash Jain |
| Correspondent | Aakash Jain INTEGRA LIFESCIENCES 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Product Code | GXQ |
| CFR Regulation Number | 882.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-28 |
| Decision Date | 2012-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M269DRM10331 | K120600 | 000 |
| M269DRM10221 | K120600 | 000 |
| M269DRM10131 | K120600 | 000 |
| M269DRM10111 | K120600 | 000 |