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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 K933254
Device Name EYEGLASS FRAMES
Applicant
Sam Chung Optical Co., Ltd.
622 Chimsan-Dong, Buk-Gu
Daegu,  KR 702-053
Applicant Contact S.H. CHUNG
Correspondent
Sam Chung Optical Co., Ltd.
622 Chimsan-Dong, Buk-Gu
Daegu,  KR 702-053
Correspondent Contact S.H. CHUNG
Regulation Number886.5850
Classification Product Code
HQY  
Date Received07/02/1993
Decision Date 09/20/1993
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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