Clearance Summary
H&M ANTI-SNORING DEVICE received FDA 510(k) clearance under submission number K882303, sponsored by Hays & Meade, 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 1989-04-14.
- Submission: K882303
- Applicant / Sponsor: Hays & Meade, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5570
- Decision date: 1989-04-14
Classification & Regulation
This clearance is catalogued under FDA product code LRK and 21 CFR 872.5570, within the Dental review panel as a Class II device.