Cleared Traditional

NOSITE UV INTERIM SPECTACLES

K823825 · Patton, Boggs & Blow · Ophthalmic
Feb 1983
Decision
66d
Days
Class 1
Risk

About This 510(k) Submission

K823825 is an FDA 510(k) clearance for the NOSITE UV INTERIM SPECTACLES, a Lens, Spectacle, Non-custom (prescription) (Class I — General Controls, product code HQG), submitted by Patton, Boggs & Blow (Mchenry, US). The FDA issued a Cleared decision on February 24, 1983, 66 days after receiving the submission on December 20, 1982. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5844.

Submission Details

510(k) Number K823825 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 1982
Decision Date February 24, 1983
Days to Decision 66 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HQG — Lens, Spectacle, Non-custom (prescription)
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.5844

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