Clearance Summary
COTTON TIPPED POINT received FDA 510(k) clearance under submission number K780929, sponsored by Young Dental Manufacturing Co. 1, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1978-06-30.
- Submission: K780929
- Applicant / Sponsor: Young Dental Manufacturing Co. 1, LLC
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6025
- Decision date: 1978-06-30
Classification & Regulation
This clearance is catalogued under FDA product code KXF and 21 CFR 880.6025, within the General Hospital review panel as a Class I device.