SPECTACLE FRAMES/SUNGLASSES— 510(k) K941051

Name: FDA 510(k) clearance K941051
Creator: U.S. Food and Drug Administration
Published: 1994-04-12

Substantially Equivalent

Europa/Encore Eyewear

FDA 510(k) clearance K941051 for SPECTACLE FRAMES/SUNGLASSES, Substantially Equivalent on 1994-04-12. Applicant: Europa/Encore Eyewear. Device class: 1.

Clearance details

Applicant: Europa/Encore Eyewear
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1994-03-03
Decision date: 1994-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wheeling, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HQY

view all

K974852 — NON-PRESCRIPTION SUNGLASSES1998-01-30
K974860 — NON-PRESCRIPTION SUNGLASSES1998-01-30
K974861 — NON-PRESCRIPTION SUNGLASSES1998-01-27
K974511 — SUNGLASSES1998-01-12
K974441 — SUNGLASSES1998-01-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.