Cleared Traditional

K900476 - WOODLYN SLIT LAMP MODEL HR-1
(FDA 510(k) Clearance)

K900476 · Woodlyn, Inc. · Ophthalmic

Feb 1990

Decision

20d

Days

Class 2

Risk

K900476 is an FDA 510(k) clearance for the WOODLYN SLIT LAMP MODEL HR-1. This device is classified as a Biomicroscope, Slit-lamp, Ac-powered (Class II — Special Controls, product code HJO).

Submitted by Woodlyn, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on February 21, 1990, 20 days after receiving the submission on February 1, 1990.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number	K900476 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 01, 1990
Decision Date	February 21, 1990
Days to Decision	20 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—