LAXIMA INTERNATIONAL LIMITED SUNGLASSES— 510(k) K970454

Name: FDA 510(k) clearance K970454
Creator: U.S. Food and Drug Administration
Published: 1997-05-06

Substantially Equivalent

Laxima Intl., Ltd.

FDA 510(k) clearance K970454 for LAXIMA INTERNATIONAL LIMITED SUNGLASSES, Substantially Equivalent on 1997-05-06. Applicant: Laxima Intl., Ltd.. Device class: 1.

Clearance details

Applicant: Laxima Intl., Ltd.
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1997-02-05
Decision date: 1997-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Central Hong Kong, HK

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K974511 — SUNGLASSES1998-01-12
K974441 — SUNGLASSES1998-01-09

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