Cleared Traditional

910T MONTORIZED INSTRUMENT TABLE

K922242 · R.H. Burton Co. · Ophthalmic
Sep 1992
Decision
140d
Days
Class 1
Risk

About This 510(k) Submission

K922242 is an FDA 510(k) clearance for the 910T MONTORIZED INSTRUMENT TABLE, a Table, Instrument, Powered, Ophthalmic (Class I — General Controls, product code HRJ), submitted by R.H. Burton Co. (Grove City, US). The FDA issued a Cleared decision on September 30, 1992, 140 days after receiving the submission on May 13, 1992. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4855.

Submission Details

510(k) Number K922242 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 1992
Decision Date September 30, 1992
Days to Decision 140 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HRJ — Table, Instrument, Powered, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4855