PRECLUDE DURA SUBSTITUTE
Device Facts
| Record ID | K953969 |
|---|---|
| Device Name | PRECLUDE DURA SUBSTITUTE |
| Applicant | W. L. Gore & Associates, Inc. |
| Product Code | GXQ · Neurology |
| Decision Date | Nov 1, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5910 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).
