Clearance Summary
HOWMEDICA BITE BLOCK received FDA 510(k) clearance under submission number K801911, sponsored by Howmedica Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1980-08-27.
- Submission: K801911
- Applicant / Sponsor: Howmedica Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6890
- Decision date: 1980-08-27
Classification & Regulation
This clearance is catalogued under FDA product code EGD and 21 CFR 872.6890, within the Dental review panel as a Class I device.