Clearance Summary
ACCLAIM received FDA 510(k) clearance under submission number K042266, sponsored by Air Techniques, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2004-08-31.
- Submission: K042266
- Applicant / Sponsor: Air Techniques, Inc.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 2004-08-31
Classification & Regulation
This clearance is catalogued under FDA product code NRD and 21 CFR 872.6640, within the Dental review panel as a Class I device.