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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 K933089
Device Name FASHION ITALIANA EYEWEAR
Applicant
Fashion Italiana, Inc.
8253 NW 56 St.
Miami,  FL  33166
Applicant Contact PIERO GALLO
Correspondent
Fashion Italiana, Inc.
8253 NW 56 St.
Miami,  FL  33166
Correspondent Contact PIERO GALLO
Regulation Number886.5850
Classification Product Code
HQY  
Subsequent Product Code
HQZ  
Date Received06/23/1993
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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