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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 K062854
Device Name BENZ-G 4X HIOXIFILCON D
Applicant
BENZ RESEARCH AND DEVELOPMENT CORP.
962 ALLEGRO LANE
APOLLO BEACH,  FL  33572
Applicant Contact ARTHUR J WARD
Correspondent
BENZ RESEARCH AND DEVELOPMENT CORP.
962 ALLEGRO LANE
APOLLO BEACH,  FL  33572
Correspondent Contact ARTHUR J WARD
Regulation Number886.5925
Classification Product Code
LPL  
Date Received09/25/2006
Decision Date 08/06/2007
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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