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510(k) Data Aggregation

K Number

Device Name

SUNGLASSES

Manufacturer

ELEGANCE OPTICAL MANUFACTORY, LTD.

Date Cleared

1997-11-18

(34 days)

Product Code

HQY

Regulation Number

886.5850

Why did this record match?

Applicant Name (Manufacturer) :

ELEGANCE OPTICAL MANUFACTORY, LTD.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections.

Device Description

Not Found

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