Clearance Summary
SILASTIC U-TUBE KIT received FDA 510(k) clearance under submission number K781526, sponsored by Dow Corning Corp. Healthcare Industries Materials. 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 1978-09-20.
- Submission: K781526
- Applicant / Sponsor: Dow Corning Corp. Healthcare Industries Materials
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4200
- Decision date: 1978-09-20
Classification & Regulation
This clearance is catalogued under FDA product code GBO and 21 CFR 878.4200, within the General, Plastic Surgery review panel as a Class I device.