Clearance Summary
LIGHT, SURGICAL ACCESSORIES received FDA 510(k) clearance under submission number K882132, sponsored by Charles Polo & Co., 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 1988-06-15.
- Submission: K882132
- Applicant / Sponsor: Charles Polo & Co., Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4580
- Decision date: 1988-06-15
Classification & Regulation
This clearance is catalogued under FDA product code FTA and 21 CFR 878.4580, within the General, Plastic Surgery review panel as a Class II device.