Clearance Summary
VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD received FDA 510(k) clearance under submission number K041669, sponsored by Synovis Surgical Innovations. 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 2004-10-27.
- Submission: K041669
- Applicant / Sponsor: Synovis Surgical Innovations
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2004-10-27
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.