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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 K943296
Device Name ILO MADE IN ITALY; GARBO HAND FINISHED ITALY
Applicant
Ilo Industria Lombarda Ottica Srl
7 Via S. Angelo
Lodi, Lo,  IT 26900
Applicant Contact ANTONIO SERRI
Correspondent
Ilo Industria Lombarda Ottica Srl
7 Via S. Angelo
Lodi, Lo,  IT 26900
Correspondent Contact ANTONIO SERRI
Regulation Number886.5850
Classification Product Code
HQY  
Date Received07/08/1994
Decision Date 09/14/1994
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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