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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 K945392
Device Name SPECTACLE FRAME
Applicant
Seo Han Corp., Ltd.
5l 26b, Dalseo Koo, Seong Seo
Industrial Estate, 2cha 1jikoo
Daegu,  KR
Applicant Contact S K BAE
Correspondent
Seo Han Corp., Ltd.
5l 26b, Dalseo Koo, Seong Seo
Industrial Estate, 2cha 1jikoo
Daegu,  KR
Correspondent Contact S K BAE
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received11/03/1994
Decision Date 12/15/1994
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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