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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Frame, Spectacle
510(k) Number K933429
Device Name MULTIPLE
Applicant
Sam Chung Optical Co., Ltd.
P.O. Box 183
Daegu, Korea,  KR
Applicant Contact S. M. CHUNG
Correspondent
Sam Chung Optical Co., Ltd.
P.O. Box 183
Daegu, Korea,  KR
Correspondent Contact S. M. CHUNG
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received07/13/1993
Decision Date 10/01/1993
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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