Clearance Summary
SNIFF POSITION PILLOWS/POPITZ PILLOWS received FDA 510(k) clearance under submission number K023010, sponsored by Aeolus International Corporation. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2002-10-01.
- Submission: K023010
- Applicant / Sponsor: Aeolus International Corporation
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5570
- Decision date: 2002-10-01
Classification & Regulation
This clearance is catalogued under FDA product code MYB and 21 CFR 872.5570, within the Dental review panel as a Class II device.