Cleared Traditional

GOGGLE SAFEGUARD

K944857 · Sellstrom Mfg. Co. · Ophthalmic

Dec 1994

Decision

76d

Days

Class 1

Risk

About This 510(k) Submission

K944857 is an FDA 510(k) clearance for the GOGGLE SAFEGUARD, a Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) (Class I — General Controls, product code HOY), submitted by Sellstrom Mfg. Co. (Palatine, US). The FDA issued a Cleared decision on December 15, 1994, 76 days after receiving the submission on September 30, 1994. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4750.

Submission Details

510(k) Number	K944857 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 1994
Decision Date	December 15, 1994
Days to Decision	76 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement

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