Clearance Summary
PRECLUDE DURA SUBSTITUTE received FDA 510(k) clearance under submission number K953969, sponsored by W. L. Gore & Associates, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1995-11-01.
- Submission: K953969
- Applicant / Sponsor: W. L. Gore & Associates, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5910
- Decision date: 1995-11-01
Classification & Regulation
This clearance is catalogued under FDA product code GXQ and 21 CFR 882.5910, within the Neurology review panel as a Class II device.