Clearance Summary
CICA-CARE SILICONE GEL SHEET received FDA 510(k) clearance under submission number K935803, sponsored by Smith & Nephew United, Inc.. 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 1994-02-03.
- Submission: K935803
- Applicant / Sponsor: Smith & Nephew United, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4025
- Decision date: 1994-02-03
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.