Clearance Summary
COTTON ROLLS received FDA 510(k) clearance under submission number K802429, sponsored by Worldwide Surgical Gauze. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1980-10-23.
- Submission: K802429
- Applicant / Sponsor: Worldwide Surgical Gauze
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6050
- Decision date: 1980-10-23
Classification & Regulation
This clearance is catalogued under FDA product code EFN and 21 CFR 872.6050, within the Dental review panel as a Class I device.