NON-PRESCRIPTION SUNGLASSES— 510(k) K974861

Name: FDA 510(k) clearance K974861
Creator: U.S. Food and Drug Administration
Published: 1998-01-27

Substantially Equivalent

Wenzhou Hindar Optical Co., Ltd.

FDA 510(k) clearance K974861 for NON-PRESCRIPTION SUNGLASSES, Substantially Equivalent on 1998-01-27. Applicant: Wenzhou Hindar Optical Co., Ltd.. Device class: 1.

Clearance details

Applicant: Wenzhou Hindar Optical Co., Ltd.
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1997-12-29
Decision date: 1998-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wenzhou City, CN

Download summary PDF View on FDA.gov ↗

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K974441 — SUNGLASSES1998-01-09
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Data sourced from openFDA. This site is unofficial and independent of the FDA.