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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Frame, Spectacle
510(k) Number K930597
Device Name SPECTACLE FRAMES
Applicant
Venis DI Alessandro Vendrame
Via Leonardo Da Vinci,4
31013 Codogne
Treviso, Italy,  IT
Applicant Contact VENDRAME ALESSANDRO
Correspondent
Venis DI Alessandro Vendrame
Via Leonardo Da Vinci,4
31013 Codogne
Treviso, Italy,  IT
Correspondent Contact VENDRAME ALESSANDRO
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received02/05/1993
Decision Date 08/02/1993
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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