Clearance Summary
DENTAL COTTON ROLLS, STERILE AND NON-STERILE received FDA 510(k) clearance under submission number K861338, sponsored by Intl. Verbandstoff-Fabrik Schaffhau. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1986-08-06.
- Submission: K861338
- Applicant / Sponsor: Intl. Verbandstoff-Fabrik Schaffhau
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6050
- Decision date: 1986-08-06
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.