The following data is part of a premarket notification filed by Integra Lifesciences Corp. with the FDA for Duragen Ii Dural Regeneration Matrix.
| Device ID | K043427 |
| 510k Number | K043427 |
| Device Name: | DURAGEN II DURAL REGENERATION MATRIX |
| Classification | Dura Substitute |
| Applicant | INTEGRA LIFESCIENCES CORP. 105 MORGAN LANE Plainsboro, NJ 08536 |
| Contact | Diana M Bordon |
| Correspondent | Diana M Bordon INTEGRA LIFESCIENCES CORP. 105 MORGAN LANE 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 | 2004-12-13 |
| Decision Date | 2005-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780023524 | K043427 | 000 |
| 10381780023517 | K043427 | 000 |
| 10381780023500 | K043427 | 000 |
| 10381780023494 | K043427 | 000 |