Clearance Summary
DUODERM TRANSPARENT HYDROCOLLOID DRESSING received FDA 510(k) clearance under submission number K925992, 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 Hospital review panel. The statutory decision date of record is 1993-10-15.
- Submission: K925992
- Applicant / Sponsor: Convatec, A Division of E.R. Squibb & Sons
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5210
- Decision date: 1993-10-15
Classification & Regulation
This clearance is catalogued under FDA product code KMK and 21 CFR 880.5210, within the General Hospital review panel as a Class I device.