Clearance Summary
ORAL SLEEP DISORDER AID received FDA 510(k) clearance under submission number K991209, sponsored by Perl-Rad Sleep Disorder Lab. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1999-09-22.
- Submission: K991209
- Applicant / Sponsor: Perl-Rad Sleep Disorder Lab
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5570
- Decision date: 1999-09-22
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.