Clearance Summary
NEON RUBBER SUNGLASSES received FDA 510(k) clearance under submission number K905183, sponsored by Ha-Lo Advertising Specialties, 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 1991-03-04.
- Submission: K905183
- Applicant / Sponsor: Ha-Lo Advertising Specialties, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5842
- Decision date: 1991-03-04
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.