K040888 is an FDA 510(k) clearance for the DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE. This device is classified as a Dura Substitute (Class II - Special Controls, product code GXQ).
Submitted by Collagen Matrix, Inc. (Franklin Lakes, US). The FDA issued a Cleared decision on December 1, 2004, 240 days after receiving the submission on April 5, 2004.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5910.
| 510(k) Number | K040888 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 2004 |
| Decision Date | December 01, 2004 |
| Days to Decision | 240 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXQ — Dura Substitute |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5910 |