Clearance Summary
PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER received FDA 510(k) clearance under submission number K915068, sponsored by American Medical Mfg., 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 1992-02-06.
- Submission: K915068
- Applicant / Sponsor: American Medical Mfg., Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4580
- Decision date: 1992-02-06
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.