The following data is part of a premarket notification filed by Integra Lifesciences Corp. with the FDA for Duragen Xs Dural Regeneration Matrix.
| Device ID | K072207 |
| 510k Number | K072207 |
| Device Name: | DURAGEN XS DURAL REGENERATION MATRIX |
| Classification | Dura Substitute |
| Applicant | INTEGRA LIFESCIENCES CORP. 311C ENTERPRISE DRIVE Plainsboro, NJ 08536 |
| Contact | Peter Allan |
| Correspondent | Peter Allan INTEGRA LIFESCIENCES CORP. 311C 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 | 2007-08-08 |
| Decision Date | 2007-08-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780070993 | K072207 | 000 |
| 10381780070986 | K072207 | 000 |
| 10381780070979 | K072207 | 000 |
| 10381780070962 | K072207 | 000 |
| 10381780070955 | K072207 | 000 |