Clearance Summary
COMFORT CUSHION DRY BURN PAD III received FDA 510(k) clearance under submission number K813419, sponsored by American Convertors Div., American Pharmaseal. 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 1982-01-22.
- Submission: K813419
- Applicant / Sponsor: American Convertors Div., American Pharmaseal
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4014
- Decision date: 1982-01-22
Classification & Regulation
This clearance is catalogued under FDA product code NAB and 21 CFR 878.4014, within the General, Plastic Surgery review panel as a Class I device.