Clearance Summary
SILASTIC VOICE PROSTHESIS received FDA 510(k) clearance under submission number K812864, sponsored by Dow Corning Corp. Healthcare Industries Materials. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1981-11-24.
- Submission: K812864
- Applicant / Sponsor: Dow Corning Corp. Healthcare Industries Materials
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3730
- Decision date: 1981-11-24
Classification & Regulation
This clearance is catalogued under FDA product code EWL and 21 CFR 874.3730, within the Ear, Nose, Throat review panel as a Class II device.