Clearance Summary
SUNGLASSES received FDA 510(k) clearance under submission number K940561, sponsored by Hibiscus Ind. 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 1994-08-04.
- Submission: K940561
- Applicant / Sponsor: Hibiscus Ind. Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5850
- Decision date: 1994-08-04
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.