Cleared Traditional

OPHTHALMIC TABLE

K841759 · Woodlyn, Inc. · Ophthalmic
Jun 1984
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K841759 is an FDA 510(k) clearance for the OPHTHALMIC TABLE, a Stand, Instrument, Ophthalmic, Non-powered (Class I — General Controls, product code HMG), submitted by Woodlyn, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 1, 1984, 35 days after receiving the submission on April 27, 1984. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1860.

Submission Details

510(k) Number K841759 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 1984
Decision Date June 01, 1984
Days to Decision 35 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary

Device Classification

Product Code HMG — Stand, Instrument, Ophthalmic, Non-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1860