Cleared Traditional

K924785 - BURTON RADIUSGAUGE - MODEL 2030
(FDA 510(k) Clearance)

K924785 · R.H. Burton Co. · Ophthalmic device

Apr 1993

Decision

194d

Days

Class 1

Risk

K924785 is an FDA 510(k) clearance for the BURTON RADIUSGAUGE - MODEL 2030. This device is classified as a Instrument, Measuring, Lens, Ac-powered (Class I - General Controls, product code HLM).

Submitted by R.H. Burton Co. (Grove City, US). The FDA issued a Cleared decision on April 5, 1993, 194 days after receiving the submission on September 23, 1992.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1425.

Submission Details

510(k) Number	K924785 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 23, 1992
Decision Date	April 05, 1993
Days to Decision	194 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement