Clearance Summary
THORA-DRAIN III PLASTIC DRAINAGE SYSTEM received FDA 510(k) clearance under submission number K801221, sponsored by Chesebrough-Pond'S U.S.A. Co.. 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 1980-06-09.
- Submission: K801221
- Applicant / Sponsor: Chesebrough-Pond'S U.S.A. Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6740
- Decision date: 1980-06-09
Classification & Regulation
This clearance is catalogued under FDA product code KDQ and 21 CFR 880.6740, within the General Hospital review panel as a Class II device.