DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE
Device Facts
| Record ID | K950956 |
|---|---|
| Device Name | DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE |
| Applicant | Bio-Vascular, Inc. |
| Product Code | GXQ · Neurology |
| Decision Date | Jun 2, 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).
