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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lenses, Soft Contact, Daily Wear
510(k) Number K101122
Device Name BENZ-G 4X (HIOXIFILCON D) MULTIFOCAL LATHED LENS
Applicant
Benz Research and Development Corp.
6447 Parkland Dr.
Sarasota,  FL  34243
Applicant Contact GIOVANNY ESPINOSA
Correspondent
Benz Research and Development Corp.
6447 Parkland Dr.
Sarasota,  FL  34243
Correspondent Contact GIOVANNY ESPINOSA
Regulation Number886.5925
Classification Product Code
LPL  
Date Received04/21/2010
Decision Date 08/09/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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