K031850 is an FDA 510(k) clearance for the DURASIS DURAL SUBSTITUTE. This device is classified as a Dura Substitute (Class II - Special Controls, product code GXQ).
Submitted by Cook Biotech, Inc. (West Lafayette, US). The FDA issued a Cleared decision on September 8, 2003, 84 days after receiving the submission on June 16, 2003.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5910.
| 510(k) Number | K031850 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 2003 |
| Decision Date | September 08, 2003 |
| Days to Decision | 84 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 |