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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 K940372
Device Name SUNGLASSES, SPECTACLE FRAMES
Applicant
Giorgio Nannini Srl
Via Del Mercato, 146
Modena,  IT 41100
Applicant Contact GIORGIA NANNINI S.R.L.
Correspondent
Giorgio Nannini Srl
Via Del Mercato, 146
Modena,  IT 41100
Correspondent Contact GIORGIA NANNINI S.R.L.
Regulation Number886.5850
Classification Product Code
HQY  
Subsequent Product Code
HQZ  
Date Received01/26/1994
Decision Date 07/25/1994
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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