Clearance Summary
INION GTR BIODEGRADABLE MEMBRANE SYSTEM received FDA 510(k) clearance under submission number K033074, sponsored by Inion , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2004-03-31.
- Submission: K033074
- Applicant / Sponsor: Inion , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3930
- Decision date: 2004-03-31
Classification & Regulation
This clearance is catalogued under FDA product code NPK and 21 CFR 872.3930, within the Dental review panel as a Class II device.