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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 K943423
Device Name SPECTACLE FRAMES
Applicant
Galilee Optics
Kfar Giladi 12210
Israel,  IL
Applicant Contact ADIEL MENAHEM
Correspondent
Galilee Optics
Kfar Giladi 12210
Israel,  IL
Correspondent Contact ADIEL MENAHEM
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received07/15/1994
Decision Date 09/06/1994
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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