Clearance Summary
MODEL 9018 PC SUNGLASSES W/POLYCARBONATE LENSES received FDA 510(k) clearance under submission number K900529, sponsored by J & B Assoc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1990-05-03.
- Submission: K900529
- Applicant / Sponsor: J & B Assoc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5850
- Decision date: 1990-05-03
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.