Clearance Summary
DISCO SUNGLASSES/HEADBAND SUNGLASSES received FDA 510(k) clearance under submission number K832564, sponsored by E-Tay Industrial Co. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1983-09-12.
- Submission: K832564
- Applicant / Sponsor: E-Tay Industrial Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5850
- Decision date: 1983-09-12
Classification & Regulation
This clearance is catalogued under FDA product code HQY and 21 CFR 886.5850, within the Ophthalmic review panel as a Class I device.