Clearance Summary
SUNGLASSES received FDA 510(k) clearance under submission number K841248, sponsored by China Toy & Novelty 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 1984-07-27.
- Submission: K841248
- Applicant / Sponsor: China Toy & Novelty Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5844
- Decision date: 1984-07-27
Classification & Regulation
This clearance is catalogued under FDA product code HQG and 21 CFR 886.5844, within the Ophthalmic review panel as a Class I device.