The following data is part of a premarket notification filed by Integra Lifesciences Corp. with the FDA for Duragen Plus Dural Graft Matrix.
| Device ID | K032693 |
| 510k Number | K032693 |
| Device Name: | DURAGEN PLUS DURAL GRAFT MATRIX |
| Classification | Dura Substitute |
| Applicant | INTEGRA LIFESCIENCES CORP. 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Diana M Bordon |
| Correspondent | Diana M Bordon INTEGRA LIFESCIENCES CORP. 311 ENTERPRISE DR. 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 | 2003-09-02 |
| Decision Date | 2003-09-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30381780070942 | K032693 | 000 |
| 10381780023449 | K032693 | 000 |
| 10381780023456 | K032693 | 000 |
| 10381780023463 | K032693 | 000 |
| 10381780023470 | K032693 | 000 |
| 10381780023487 | K032693 | 000 |
| 30381780070911 | K032693 | 000 |
| 30381780070928 | K032693 | 000 |
| 30381780070935 | K032693 | 000 |
| 10381780023432 | K032693 | 000 |