Clearance Summary
SPECTACLE FRAME received FDA 510(k) clearance under submission number K944313, sponsored by Sun Hing Optical Manufactory , 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 1995-03-28.
- Submission: K944313
- Applicant / Sponsor: Sun Hing Optical Manufactory , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5842
- Decision date: 1995-03-28
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.