The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Duragen Plus Dural Regeneration Matrix- Spinal Matrix, Model Dp2013sm, Integra Spinal Mend Dural Regeneration Matrix, Mo.
| Device ID | K092388 |
| 510k Number | K092388 |
| Device Name: | DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO |
| Classification | Dura Substitute |
| Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Peter Allan |
| Correspondent | Peter Allan INTEGRA LIFESCIENCES CORPORATION 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 | 2009-08-05 |
| Decision Date | 2010-01-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780070726 | K092388 | 000 |