Clearance Summary
DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE received FDA 510(k) clearance under submission number K950956, sponsored by Bio-Vascular, 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 1995-06-02.
- Submission: K950956
- Applicant / Sponsor: Bio-Vascular, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5910
- Decision date: 1995-06-02
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.