Clearance Summary
CONTINENT STOMA SYSTEM & ACCESSORIES received FDA 510(k) clearance under submission number K844186, sponsored by Chesebrough-Pond'S U.S.A. Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1985-01-15.
- Submission: K844186
- Applicant / Sponsor: Chesebrough-Pond'S U.S.A. Co.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4420
- Decision date: 1985-01-15
Classification & Regulation
This clearance is catalogued under FDA product code KBG and 21 CFR 874.4420, within the Ear, Nose, Throat review panel as a Class I device.