NEW SUN OPTICAL NON PRESCRIPTION SUNGLASSES— 510(k) K953627

Name: FDA 510(k) clearance K953627
Creator: U.S. Food and Drug Administration
Published: 1995-10-25

Substantially Equivalent

New Sun Optical Enterprise Co., Ltd.

FDA 510(k) clearance K953627 for NEW SUN OPTICAL NON PRESCRIPTION SUNGLASSES, Substantially Equivalent on 1995-10-25. Applicant: New Sun Optical Enterprise Co., Ltd.. Device class: 1.

Clearance details

Applicant: New Sun Optical Enterprise Co., Ltd.
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1995-07-31
Decision date: 1995-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taiwan Hsien, TW

Download summary PDF View on FDA.gov ↗

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K974441 — SUNGLASSES1998-01-09

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