Clearance Summary
PHOTO-THERAPY EYE PROTECTOR received FDA 510(k) clearance under submission number K840894, sponsored by A & A Medical Supplies Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1984-03-23.
- Submission: K840894
- Applicant / Sponsor: A & A Medical Supplies Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5270
- Decision date: 1984-03-23
Classification & Regulation
This clearance is catalogued under FDA product code FOK and 21 CFR 880.5270, within the General Hospital review panel as a Class I device.