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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 K963075
Device Name FITO DIDO
Applicant
Framesmart, Inc.
8666 NW 58th St.
Miami,  FL  33166 -3306
Applicant Contact FERNANDO CARRANZA
Correspondent
Framesmart, Inc.
8666 NW 58th St.
Miami,  FL  33166 -3306
Correspondent Contact FERNANDO CARRANZA
Regulation Number886.5850
Classification Product Code
HQY  
Date Received07/24/1996
Decision Date 08/22/1996
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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