Clearance Summary
SNORENTI received FDA 510(k) clearance under submission number K032410, sponsored by James P Boyd. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2005-02-28.
- Submission: K032410
- Applicant / Sponsor: James P Boyd
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5570
- Decision date: 2005-02-28
Classification & Regulation
This clearance is catalogued under FDA product code LQZ and 21 CFR 872.5570, within the Dental review panel as a Class II device.