Clearance Summary
OPTI-DISC received FDA 510(k) clearance under submission number K820626, sponsored by Video-Medical Devices, Ltd.. 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 1982-04-09.
- Submission: K820626
- Applicant / Sponsor: Video-Medical Devices, Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4160
- Decision date: 1982-04-09
Classification & Regulation
This clearance is catalogued under FDA product code KQM and 21 CFR 878.4160, within the General, Plastic Surgery review panel as a Class I device.