Cleared Traditional

K844363 - OPHTHALMIC STAND
(FDA 510(k) Clearance)

K844363 · Luneau Laboratories · Ophthalmic

Dec 1984

Decision

22d

Days

Class 1

Risk

K844363 is an FDA 510(k) clearance for the OPHTHALMIC STAND. This device is classified as a Stand, Instrument, Ac-powered, Ophthalmic (Class I — General Controls, product code HMF).

Submitted by Luneau Laboratories (Washington, US). The FDA issued a Cleared decision on December 5, 1984, 22 days after receiving the submission on November 13, 1984.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1860.

Submission Details

510(k) Number	K844363 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 13, 1984
Decision Date	December 05, 1984
Days to Decision	22 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—