Clearance Summary
GUM MASSAGER received FDA 510(k) clearance under submission number K911418, sponsored by Burn-Henderson Partnership. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1991-07-17.
- Submission: K911418
- Applicant / Sponsor: Burn-Henderson Partnership
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6650
- Decision date: 1991-07-17
Classification & Regulation
This clearance is catalogued under FDA product code JET and 21 CFR 872.6650, within the Dental review panel as a Class I device.