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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 K903739
Device Name SUNGLASSES W/NON PRESCRIPT LENSES W/PHOTO SENSITIV
Applicant
NOUVEAU EYEWEAR
17802 DAVENPORT #102
DALLAS,  TX  75252
Applicant Contact NANCY MOLNY
Correspondent
NOUVEAU EYEWEAR
17802 DAVENPORT #102
DALLAS,  TX  75252
Correspondent Contact NANCY MOLNY
Regulation Number886.5850
Classification Product Code
HQY  
Date Received08/16/1990
Decision Date 09/17/1990
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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