Clearance Summary
DUODERM HYDROCOLLOID GEL received FDA 510(k) clearance under submission number K931618, sponsored by Convatec, A Division of E.R. Squibb & Sons. 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 1993-12-10.
- Submission: K931618
- Applicant / Sponsor: Convatec, A Division of E.R. Squibb & Sons
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4022
- Decision date: 1993-12-10
Classification & Regulation
This clearance is catalogued under FDA product code NAE and 21 CFR 878.4022, within the General, Plastic Surgery review panel as a Class I device.