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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 K934120
Device Name NON-PRESCRIPTION EYEGLASS FRAMES & SUNGLASSES VARIOUS STYLES
Applicant
LUX DE PARIS, INC.
7270 N.W. 58TH ST.
MIAMI,  FL  33166
Applicant Contact BERNARD PEDOUSSAUT
Correspondent
LUX DE PARIS, INC.
7270 N.W. 58TH ST.
MIAMI,  FL  33166
Correspondent Contact BERNARD PEDOUSSAUT
Regulation Number886.5850
Classification Product Code
HQY  
Subsequent Product Code
HQZ  
Date Received08/24/1993
Decision Date 10/18/1993
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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