Clearance Summary
COMFEEL PROTECTIVE RINGS received FDA 510(k) clearance under submission number K832908, sponsored by Coloplast A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1983-12-12.
- Submission: K832908
- Applicant / Sponsor: Coloplast A/S
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4014
- Decision date: 1983-12-12
Classification & Regulation
This clearance is catalogued under FDA product code EYF and 21 CFR 878.4014, within the General, Plastic Surgery review panel as a Class I device.