K041518 is an FDA 510(k) clearance for the CODMAN DURAFORM DURAL GRAFT IMPLANT. This device is classified as a Dura Substitute (Class II - Special Controls, product code GXQ).
Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on June 22, 2004, 15 days after receiving the submission on June 7, 2004.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5910.
| 510(k) Number | K041518 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 2004 |
| Decision Date | June 22, 2004 |
| Days to Decision | 15 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXQ - Dura Substitute |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5910 |