Cleared Traditional

SCHWARTZ/NORRIS CORNEAL LIGHT SHIELD

K844761 · Medical Instrument Development Laboratories, Inc. · Ophthalmic

Dec 1984

Decision

17d

Days

Class 1

Risk

About This 510(k) Submission

K844761 is an FDA 510(k) clearance for the SCHWARTZ/NORRIS CORNEAL LIGHT SHIELD, a Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) (Class I — General Controls, product code HOY), submitted by Medical Instrument Development Laboratories, Inc. (San Leandro, US). The FDA issued a Cleared decision on December 24, 1984, 17 days after receiving the submission on December 7, 1984. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4750.

Submission Details

510(k) Number	K844761 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 07, 1984
Decision Date	December 24, 1984
Days to Decision	17 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—

Device Classification

Product Code	HOY — Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
Device Class	Class I — General Controls
CFR Regulation	21 CFR 886.4750