Cleared Traditional

WOODLYN LIGHTWEIGHT TRIAL FRAME

K841768 · Woodlyn, Inc. · Ophthalmic

Jun 1984

Decision

35d

Days

Class 1

Risk

About This 510(k) Submission

K841768 is an FDA 510(k) clearance for the WOODLYN LIGHTWEIGHT TRIAL FRAME, a Frame, Trial, Ophthalmic (Class I — General Controls, product code HPA), 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 886.1415.

Submission Details

510(k) Number	K841768 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	—