Cleared Traditional

BURTON HAND HELD SLIT LAMP - MODEL SL750

K924770 · R.H. Burton Co. · Ophthalmic
Jan 1993
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K924770 is an FDA 510(k) clearance for the BURTON HAND HELD SLIT LAMP - MODEL SL750, 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 January 27, 1993, 126 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 K924770 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 1992
Decision Date January 27, 1993
Days to Decision 126 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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