SUNGLASSES (NON-PRESCRIPTION)— 510(k) K971707

Name: FDA 510(k) clearance K971707
Creator: U.S. Food and Drug Administration
Published: 1997-06-13

Substantially Equivalent

Niko Sunglasses Corp.

FDA 510(k) clearance K971707 for SUNGLASSES (NON-PRESCRIPTION), Substantially Equivalent on 1997-06-13. Applicant: Niko Sunglasses Corp.. Device class: 1.

Clearance details

Applicant: Niko Sunglasses Corp.
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1997-05-06
Decision date: 1997-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HQY

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K974852 — NON-PRESCRIPTION SUNGLASSES1998-01-30
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.