Clearance Summary
SNOREFREE received FDA 510(k) clearance under submission number K955336, sponsored by Scott Feldman Dds & Norman Shapiro Dds. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1996-01-04.
- Submission: K955336
- Applicant / Sponsor: Scott Feldman Dds & Norman Shapiro Dds
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5570
- Decision date: 1996-01-04
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.