Clearance Summary
BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT received FDA 510(k) clearance under submission number K131015, sponsored by Cook Biotech, 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 2013-10-08.
- Submission: K131015
- Applicant / Sponsor: Cook Biotech, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5910
- Decision date: 2013-10-08
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.