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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 K903949
Device Name FRAME, SPECTACLE
Applicant
Eureka Optics, Inc.
P.O. Box 332
Toegu, Korea,  KR
Applicant Contact C. B SOHN
Correspondent
Eureka Optics, Inc.
P.O. Box 332
Toegu, Korea,  KR
Correspondent Contact C. B SOHN
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received08/28/1990
Decision Date 09/10/1990
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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