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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sunglasses (Non-Prescription Including Photosensitive)
510(k) Number K944026
Device Name MIRAGE EYEWEAR INC.
Applicant
Mirage Eyewear, Inc.
961 Meridian Ave.
Alhambra,  CA  91803
Applicant Contact DAVID HSU
Correspondent
Mirage Eyewear, Inc.
961 Meridian Ave.
Alhambra,  CA  91803
Correspondent Contact DAVID HSU
Regulation Number886.5850
Classification Product Code
HQY  
Date Received08/17/1994
Decision Date 09/14/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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