SPECTACLE FRAMES AND SUNGLASSES— 510(k) K933189

Name: FDA 510(k) clearance K933189
Creator: U.S. Food and Drug Administration
Published: 1994-01-25

Substantially Equivalent

Eastern Breeze Intl. Co.

FDA 510(k) clearance K933189 for SPECTACLE FRAMES AND SUNGLASSES, Substantially Equivalent on 1994-01-25. Applicant: Eastern Breeze Intl. Co.. Device class: 1.

Clearance details

Applicant: Eastern Breeze Intl. Co.
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1993-06-30
Decision date: 1994-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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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.