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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 K963968
Device Name FLYWAY
Applicant
Look Style, S.R.L.
Via S. Giovanni N. 56
Calalzo Di Cadore, (Bl),  IT 32042
Applicant Contact TIBERIO GIORGIO
Correspondent
Look Style, S.R.L.
Via S. Giovanni N. 56
Calalzo Di Cadore, (Bl),  IT 32042
Correspondent Contact TIBERIO GIORGIO
Regulation Number886.5850
Classification Product Code
HQY  
Date Received10/03/1996
Decision Date 11/19/1996
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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