Clearance Summary
NOSITE UV INTERIM SPECTACLES received FDA 510(k) clearance under submission number K823825, sponsored by Patton, Boggs & Blow. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1983-02-24.
- Submission: K823825
- Applicant / Sponsor: Patton, Boggs & Blow
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5844
- Decision date: 1983-02-24
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.