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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 K941047
Device Name WESTERN TRADING CO
Applicant
Eva Optiks, Inc.
P.O. Box 987.
Kaohsiung, Taiwan,  TW
Applicant Contact BASIL LIN
Correspondent
Eva Optiks, Inc.
P.O. Box 987.
Kaohsiung, Taiwan,  TW
Correspondent Contact BASIL LIN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received03/07/1994
Decision Date 07/12/1994
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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