Clearance Summary
A-COMPANY ESPREE SAFETY HEADGEAR received FDA 510(k) clearance under submission number K852670, sponsored by A Company, 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 1985-07-31.
- Submission: K852670
- Applicant / Sponsor: A Company, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5500
- Decision date: 1985-07-31
Classification & Regulation
This clearance is catalogued under FDA product code DZB and 21 CFR 872.5500, within the Dental review panel as a Class II device.