The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Dural Graft Implant, Models 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1.
| Device ID | K033395 |
| 510k Number | K033395 |
| Device Name: | CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1 |
| Classification | Strip, Craniosynostosis, Preformed |
| Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Liz Dolan |
| Correspondent | Liz Dolan Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | GXO |
| CFR Regulation Number | 882.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-23 |
| Decision Date | 2004-02-25 |
| Summary: | summary |