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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 K935969
Device Name SPECTACLE FRAMES
Applicant
Tae Kyung Optical Co., Inc.
3651 W. Irving Park
Chicago,  IL  60618
Applicant Contact JANET IRGANG
Correspondent
Tae Kyung Optical Co., Inc.
3651 W. Irving Park
Chicago,  IL  60618
Correspondent Contact JANET IRGANG
Regulation Number886.5850
Classification Product Code
HQY  
Subsequent Product Code
HQZ  
Date Received12/13/1993
Decision Date 02/22/1994
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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