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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 K972590
Device Name NEVADA EYEWORKS, LUIGI LANATTA SUNGLASSES
Applicant
Lbi U.S.A.
20801 Nordhoff St.
Chatsworth,  CA  91311
Applicant Contact KEITH LEHRER
Correspondent
Lbi U.S.A.
20801 Nordhoff St.
Chatsworth,  CA  91311
Correspondent Contact KEITH LEHRER
Regulation Number886.5850
Classification Product Code
HQY  
Date Received07/11/1997
Decision Date 07/31/1997
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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