Clearance Summary
SPECTACLE FRAME received FDA 510(k) clearance under submission number K943085, sponsored by Winntics Optical Industry 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: K943085
- Applicant / Sponsor: Winntics Optical Industry Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5842
- Decision date: 1994-08-04
Classification & Regulation
This clearance is catalogued under FDA product code HQZ and 21 CFR 886.5842, within the Ophthalmic review panel as a Class I device.