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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 K932821
Device Name APEX OPTICAL IND. CO., EYE WEA MODELS
Applicant
Apex Optical Ind. Co.
Rm.302,3/F,Shin Hwa Bldg.
75-6,Sungdang-Dong,Dalseu-Ku
Daegu, Korea,  KR
Applicant Contact LEE
Correspondent
Apex Optical Ind. Co.
Rm.302,3/F,Shin Hwa Bldg.
75-6,Sungdang-Dong,Dalseu-Ku
Daegu, Korea,  KR
Correspondent Contact LEE
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received06/09/1993
Decision Date 01/25/1994
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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