Cleared Traditional

WORTH 4 DOT TEST DISTANCE C/W MUSCLE LIGHT

K874251 · Richmond Products, Inc. · Ophthalmic
Jan 1988
Decision
84d
Days
Class 1
Risk

About This 510(k) Submission

K874251 is an FDA 510(k) clearance for the WORTH 4 DOT TEST DISTANCE C/W MUSCLE LIGHT, a Target, Fusion And Stereoscopic (Class I — General Controls, product code HLP), submitted by Richmond Products, Inc. (Boca Raton, US). The FDA issued a Cleared decision on January 11, 1988, 84 days after receiving the submission on October 19, 1987. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1880.

Submission Details

510(k) Number K874251 FDA.gov
FDA Decision Cleared SESE
Date Received October 19, 1987
Decision Date January 11, 1988
Days to Decision 84 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary

Device Classification

Product Code HLP — Target, Fusion And Stereoscopic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1880