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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sunglasses (Non-Prescription Including Photosensitive)
510(k) Number K901167
Device Name (EYEGLASS) FRAMES AND SUNGLASSES
Applicant
Optique Marquis, Div. Sugerose, Inc.
P.O. Box 2078
San Antonio,  TX  78297
Applicant Contact CHARLES I SOLOMON
Correspondent
Optique Marquis, Div. Sugerose, Inc.
P.O. Box 2078
San Antonio,  TX  78297
Correspondent Contact CHARLES I SOLOMON
Regulation Number886.5850
Classification Product Code
HQY  
Date Received03/13/1990
Decision Date 06/14/1990
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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