NON-PRESCRIPTION SUNGLASSES— 510(k) K941055

Name: FDA 510(k) clearance K941055
Creator: U.S. Food and Drug Administration
Published: 1994-04-12

Substantially Equivalent

Kingsun Optical Ent. Co., Ltd.

FDA 510(k) clearance K941055 for NON-PRESCRIPTION SUNGLASSES, Substantially Equivalent on 1994-04-12. Applicant: Kingsun Optical Ent. Co., Ltd.. Device class: 1.

Clearance details

Applicant: Kingsun Optical Ent. Co., Ltd.
Product code: Code HQY
Device class: Class 1
Regulation: 21 CFR 886.5850
Advisory panel: Ophthalmic
Date received: 1994-03-03
Decision date: 1994-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taiwan, R.O.C., TW

Download summary PDF View on FDA.gov ↗

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