Clearance Summary
POLYURETHANE SOLUTION 29% W/W received FDA 510(k) clearance under submission number K944934, sponsored by Knowell Therapeutic Technologies,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 1994-12-09.
- Submission: K944934
- Applicant / Sponsor: Knowell Therapeutic Technologies,Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3260
- Decision date: 1994-12-09
Classification & Regulation
This clearance is catalogued under FDA product code LBH and 21 CFR 872.3260, within the Dental review panel as a Class II device.