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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 K950079
Device Name SUNGLASSES
Applicant
Gianni Versace
5454 Boutique Corp.
5454 Wisconsin Ave.
Chevy Chase,  MD  20815
Applicant Contact RALPH PATERNO
Correspondent
Gianni Versace
5454 Boutique Corp.
5454 Wisconsin Ave.
Chevy Chase,  MD  20815
Correspondent Contact RALPH PATERNO
Regulation Number886.5850
Classification Product Code
HQY  
Date Received01/10/1995
Decision Date 02/07/1995
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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