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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 K961117
Device Name VISARD SUNGLASSES
Applicant
Visard Srl
Via Feltrina, 18
32030 Quero
Belluno,  IT
Applicant Contact STRAMARE ANGELO
Correspondent
Visard Srl
Via Feltrina, 18
32030 Quero
Belluno,  IT
Correspondent Contact STRAMARE ANGELO
Regulation Number886.5850
Classification Product Code
HQY  
Date Received03/20/1996
Decision Date 04/24/1996
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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