Clearance Summary
EAGLE DS received FDA 510(k) clearance under submission number K895164, sponsored by American Sterilizer Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1989-11-17.
- Submission: K895164
- Applicant / Sponsor: American Sterilizer Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6710
- Decision date: 1989-11-17
Classification & Regulation
This clearance is catalogued under FDA product code ECG and 21 CFR 872.6710, within the Dental review panel as a Class I device.