Clearance Summary
MUCOSAL ADJUSTMENT PASTE LIQUID SPRAY received FDA 510(k) clearance under submission number K833132, sponsored by Myo-Tronics Research, 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 1984-02-10.
- Submission: K833132
- Applicant / Sponsor: Myo-Tronics Research, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6140
- Decision date: 1984-02-10
Classification & Regulation
This clearance is catalogued under FDA product code EFH and 21 CFR 872.6140, within the Dental review panel as a Class I device.