Clearance Summary
JAMES ALEX SUNGLASSES received FDA 510(k) clearance under submission number K970101, sponsored by D&K Stores, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1997-03-04.
- Submission: K970101
- Applicant / Sponsor: D&K Stores, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5850
- Decision date: 1997-03-04
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.