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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 K903173
Device Name LAURENT TARDY
Applicant
Acces Intl. Eyewear
444 Bunker Rd.
West Palm Beach,  FL  33405
Applicant Contact STEPHAN LAUDICINO
Correspondent
Acces Intl. Eyewear
444 Bunker Rd.
West Palm Beach,  FL  33405
Correspondent Contact STEPHAN LAUDICINO
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received07/18/1990
Decision Date 08/02/1990
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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