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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 K935798
Device Name MULTIPLE -SPECTACLE FRAMES/SUNGLASSES
Applicant
Tae Kyung Optical Co., Inc.
996-3 3ka Nowon-Dong Buk-Gu
Daegu, Korea 702-083,  KR
Applicant Contact LEO SANDERS
Correspondent
Tae Kyung Optical Co., Inc.
996-3 3ka Nowon-Dong Buk-Gu
Daegu, Korea 702-083,  KR
Correspondent Contact LEO SANDERS
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received12/02/1993
Decision Date 02/16/1994
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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