Clearance Summary
FIBRETWINS received FDA 510(k) clearance under submission number K913603, sponsored by Oral-B Laboratories. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1991-09-30.
- Submission: K913603
- Applicant / Sponsor: Oral-B Laboratories
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 1991-09-30
Classification & Regulation
This clearance is catalogued under FDA product code KNT and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.