Clearance Summary
SUNGLASSES received FDA 510(k) clearance under submission number K844778, sponsored by B & M Sporting Goods, 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 1985-01-04.
- Submission: K844778
- Applicant / Sponsor: B & M Sporting Goods, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5844
- Decision date: 1985-01-04
Classification & Regulation
This clearance is catalogued under FDA product code HQG and 21 CFR 886.5844, within the Ophthalmic review panel as a Class I device.