21 CFR 882.5910 — Dura Substitute
Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5910
Identification
A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GXQ | Dura Substitute | 2 | 43 | Implant |
