Clearance Summary
CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090 received FDA 510(k) clearance under submission number K090083, sponsored by Unicare Biomedical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2009-03-23.
- Submission: K090083
- Applicant / Sponsor: Unicare Biomedical, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3930
- Decision date: 2009-03-23
Classification & Regulation
This clearance is catalogued under FDA product code LYC and 21 CFR 872.3930, within the Dental review panel as a Class II device.