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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 K945450
Device Name FRAME, SPECTACLE
Applicant
Kookje Apis Industrial Co.
Rm. 600 120-13
Sosomoontong Choong-Ku
Seoul,  KR
Applicant Contact HAETONG SOHN
Correspondent
Kookje Apis Industrial Co.
Rm. 600 120-13
Sosomoontong Choong-Ku
Seoul,  KR
Correspondent Contact HAETONG SOHN
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received11/03/1994
Decision Date 11/22/1994
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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