DISCO SUNGLASSES (NON-PRESCRIPTION)— 510(k) K900387

Name: FDA 510(k) clearance K900387
Creator: U.S. Food and Drug Administration
Published: 1990-02-28

Substantially Equivalent

Le-I Electronic Co. , Ltd.

FDA 510(k) clearance K900387 for DISCO SUNGLASSES (NON-PRESCRIPTION), Substantially Equivalent on 1990-02-28. Applicant: Le-I Electronic Co. , Ltd.. Device class: 1.

Clearance details

Applicant: Le-I Electronic Co. , Ltd.
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1990-01-29
Decision date: 1990-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shoreham, NY, US

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K974441 — SUNGLASSES1998-01-09

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