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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 K933138
Device Name INFLUENCE,ARIA,MASERATI,ROCHAS,ANGELO,TARLAZZI
Applicant
Aria Advanced Eyewear, Inc.
6065 NW 167th St., #B-22
Miami,  FL  33015
Applicant Contact PIERRE MARECHAL
Correspondent
Aria Advanced Eyewear, Inc.
6065 NW 167th St., #B-22
Miami,  FL  33015
Correspondent Contact PIERRE MARECHAL
Regulation Number886.5850
Classification Product Code
HQY  
Date Received06/28/1993
Decision Date 10/01/1993
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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