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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 K972362
Device Name FOVS, BRILLARTE, ETC...
Applicant
SUNGLASS CITY, INC.
7220 N.W. 36TH ST., SUITE 309
MIAMI,  FL  33166
Applicant Contact AULIO GIRON
Correspondent
SUNGLASS CITY, INC.
7220 N.W. 36TH ST., SUITE 309
MIAMI,  FL  33166
Correspondent Contact AULIO GIRON
Regulation Number886.5850
Classification Product Code
HQY  
Date Received06/25/1997
Decision Date 07/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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