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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 K943792
Device Name SPECTACLE FRAMES
Applicant
Kt Optique, Inc.
5-627 Itagaki
Fukui, 910,  JP
Applicant Contact KEN IIDA
Correspondent
Kt Optique, Inc.
5-627 Itagaki
Fukui, 910,  JP
Correspondent Contact KEN IIDA
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received08/03/1994
Decision Date 09/14/1994
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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