SPECTACLE SUN GLASSES (NON PRESCRIPTION)— 510(k) K954173

Name: FDA 510(k) clearance K954173
Creator: U.S. Food and Drug Administration
Published: 1995-10-03

Substantially Equivalent

Monte Carlo Eyewear, Inc.

FDA 510(k) clearance K954173 for SPECTACLE SUN GLASSES (NON PRESCRIPTION), Substantially Equivalent on 1995-10-03. Applicant: Monte Carlo Eyewear, Inc.. Device class: 1.

Clearance details

Applicant: Monte Carlo Eyewear, Inc.
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1995-09-05
Decision date: 1995-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

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K974441 — SUNGLASSES1998-01-09

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