Clearance Summary
COMFEEL POWDER received FDA 510(k) clearance under submission number K834343, 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 1984-11-08.
- Submission: K834343
- Applicant / Sponsor: Coloplast A/S
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4018
- Decision date: 1984-11-08
Classification & Regulation
This clearance is catalogued under FDA product code KOZ and 21 CFR 878.4018, within the General, Plastic Surgery review panel as a Class I device.