Clearance Summary
BRAUN TRAVEL received FDA 510(k) clearance under submission number K810666, sponsored by Gilette Medical Eval. Laboratory. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1981-04-14.
- Submission: K810666
- Applicant / Sponsor: Gilette Medical Eval. Laboratory
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6865
- Decision date: 1981-04-14
Classification & Regulation
This clearance is catalogued under FDA product code JEQ and 21 CFR 872.6865, within the Dental review panel as a Class I device.