K033395 is an FDA 510(k) clearance for the 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. This device is classified as a Strip, Craniosynostosis, Preformed (Class II - Special Controls, product code GXO).
Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on February 25, 2004, 125 days after receiving the submission on October 23, 2003.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5900.
| 510(k) Number | K033395 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 2003 |
| Decision Date | February 25, 2004 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXO - Strip, Craniosynostosis, Preformed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5900 |