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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 K082393
Device Name CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
Applicant
Unilens Corp., USA
10431 72nd St., N.
Largo,  FL  33777
Applicant Contact ALAN J FRAZER
Correspondent
Unilens Corp., USA
10431 72nd St., N.
Largo,  FL  33777
Correspondent Contact ALAN J FRAZER
Regulation Number886.5925
Classification Product Code
LPL  
Date Received08/19/2008
Decision Date 09/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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