Cleared Traditional

WOODLYN CLASSIC INSTRUMENT STAND

K841760 · Woodlyn, Inc. · Ophthalmic
Jun 1984
Decision
53d
Days
Class 1
Risk

About This 510(k) Submission

K841760 is an FDA 510(k) clearance for the WOODLYN CLASSIC INSTRUMENT STAND, a Table, Instrument, Powered, Ophthalmic (Class I — General Controls, product code HRJ), submitted by Woodlyn, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 19, 1984, 53 days after receiving the submission on April 27, 1984. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4855.

Submission Details

510(k) Number K841760 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 1984
Decision Date June 19, 1984
Days to Decision 53 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

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