Cleared Traditional

BURTON SLIT LAMP - MODEL 850

K924783 · R.H. Burton Co. · Ophthalmic
Apr 1993
Decision
203d
Days
Class 2
Risk

About This 510(k) Submission

K924783 is an FDA 510(k) clearance for the BURTON SLIT LAMP - MODEL 850, a Biomicroscope, Slit-lamp, Ac-powered (Class II — Special Controls, product code HJO), submitted by R.H. Burton Co. (Grove City, US). The FDA issued a Cleared decision on April 14, 1993, 203 days after receiving the submission on September 23, 1992. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number K924783 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 1992
Decision Date April 14, 1993
Days to Decision 203 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HJO — Biomicroscope, Slit-lamp, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1850

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