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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 K083288
Device Name DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER
Applicant
Innova Vision, Inc.
2904 N. Boldt Dr.
Flagstaff,  AZ  86001
Applicant Contact JENNIFER REICH
Correspondent
Innova Vision, Inc.
2904 N. Boldt Dr.
Flagstaff,  AZ  86001
Correspondent Contact JENNIFER REICH
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received11/07/2008
Decision Date 09/03/2009
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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