Clearance Summary
NON-PRESCRIPTION SUNGLASSES received FDA 510(k) clearance under submission number K974179, sponsored by Taipan Optical Company , 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 1997-12-01.
- Submission: K974179
- Applicant / Sponsor: Taipan Optical Company , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5850
- Decision date: 1997-12-01
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.