Clearance Summary
COLLAGEN TENDON WRAP received FDA 510(k) clearance under submission number K080452, sponsored by Collagen Matrix, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2008-05-15.
- Submission: K080452
- Applicant / Sponsor: Collagen Matrix, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2008-05-15
Classification & Regulation
This clearance is catalogued under FDA product code FTM and 21 CFR 878.3300, within the General, Plastic Surgery review panel as a Class II device.