Clearance Summary
MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD received FDA 510(k) clearance under submission number K003979, sponsored by Medtrade Products , Ltd.. 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 2001-03-19.
- Submission: K003979
- Applicant / Sponsor: Medtrade Products , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4025
- Decision date: 2001-03-19
Classification & Regulation
This clearance is catalogued under FDA product code MDA and 21 CFR 878.4025, within the General, Plastic Surgery review panel as a Class I device.