← Product Code [GXQ](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXQ) · K953969

# PRECLUDE DURA SUBSTITUTE (K953969)

_W. L. Gore & Associates, Inc. · GXQ · Nov 1, 1995 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXQ/K953969

## Device Facts

- **Applicant:** W. L. Gore & Associates, Inc.
- **Product Code:** [GXQ](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXQ.md)
- **Decision Date:** Nov 1, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.5910
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXQ/K953969](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GXQ/K953969)

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