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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 K023989
Device Name CONTAFLEX 55 (METHAFILCON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)
Applicant
Contamac, Ltd.
623 Glacier Dr.
Grand Junction,  CO  81503
Applicant Contact MARTIN DALSING
Correspondent
Contamac, Ltd.
623 Glacier Dr.
Grand Junction,  CO  81503
Correspondent Contact MARTIN DALSING
Regulation Number886.5925
Classification Product Code
LPL  
Date Received12/02/2002
Decision Date 02/26/2003
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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