Clearance Summary
CS-11 received FDA 510(k) clearance under submission number K832500, sponsored by Chema-Scutum, 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 1983-10-27.
- Submission: K832500
- Applicant / Sponsor: Chema-Scutum, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3300
- Decision date: 1983-10-27
Classification & Regulation
This clearance is catalogued under FDA product code EBE and 21 CFR 872.3300, within the Dental review panel as a Class II device.