Clearance Summary
LEWIS SAFE SLEEVE received FDA 510(k) clearance under submission number K873960, sponsored by Cheri Lewis, D.D.S.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1987-12-04.
- Submission: K873960
- Applicant / Sponsor: Cheri Lewis, D.D.S.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1987-12-04
Classification & Regulation
This clearance is catalogued under FDA product code EIF and 21 CFR 872.4565, within the Dental review panel as a Class I device.