Cleared Traditional

WOODLYN CLASSIC TRIAL LENS SET

K841766 · Woodlyn, Inc. · Ophthalmic
Jun 1984
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K841766 is an FDA 510(k) clearance for the WOODLYN CLASSIC TRIAL LENS SET, a Set, Lens, Trial, Ophthalmic (Class I — General Controls, product code HPC), 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 886.1405.

Submission Details

510(k) Number K841766 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 HPC — Set, Lens, Trial, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1405