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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 K010507
Device Name VISTAKON (METHAFILCON A) CONTACT LENSES
Applicant
Vistakon
7500 Centurion Pkwy., Suite 100
Jacksonville,  FL  32256
Applicant Contact MICHAEL J TERSAK
Correspondent
Vistakon
7500 Centurion Pkwy., Suite 100
Jacksonville,  FL  32256
Correspondent Contact MICHAEL J TERSAK
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received02/21/2001
Decision Date 04/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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