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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 K023077
Device Name OCU-FLEX PEDIATRIC APHAKIC (OCUFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (LATHE-CUT)
Applicant
Ocu-Ease Optical Products, Inc.
623 Glacier Dr.
Grand Junction,  CO  81503
Applicant Contact DEANNA WERBER
Correspondent
Ocu-Ease Optical Products, Inc.
623 Glacier Dr.
Grand Junction,  CO  81503
Correspondent Contact DEANNA WERBER
Regulation Number886.5925
Classification Product Code
LPL  
Date Received09/16/2002
Decision Date 12/10/2002
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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