The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Duraform Dural Graft Implant.
| Device ID | K041518 |
| 510k Number | K041518 |
| Device Name: | CODMAN DURAFORM DURAL GRAFT IMPLANT |
| Classification | Dura Substitute |
| Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Elizabeth Dolan |
| Correspondent | Elizabeth Dolan Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | GXQ |
| CFR Regulation Number | 882.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-07 |
| Decision Date | 2004-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886704036746 | K041518 | 000 |
| 20886704036736 | K041518 | 000 |
| 10886704036722 | K041518 | 000 |
| 20886704036712 | K041518 | 000 |
| 10886704036708 | K041518 | 000 |
| 20886704036699 | K041518 | 000 |
| 10886704036685 | K041518 | 000 |
| 20886704036675 | K041518 | 000 |