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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 K945176
Device Name SPECTACLE FRAME OR EYEGLASS FRAMES
Applicant
Optipia Trading Co.
4th Floor
98-4 Wondae 2ga Seogu
Daegu,  KR 2A SEOGU
Applicant Contact S T KING
Correspondent
Optipia Trading Co.
4th Floor
98-4 Wondae 2ga Seogu
Daegu,  KR 2A SEOGU
Correspondent Contact S T KING
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received10/24/1994
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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