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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 K021720
Device Name MULTIVISION METHAFILCON A SOFT (HYDROPILIC) MULTIFOCAL LENS FOR DAILY WEAR
Applicant
Soflex Isralens Contact Lens , Ltd.
Moshav Manof
20184 Misgav,  IL 20184
Applicant Contact Kevin Walls
Correspondent
Soflex Isralens Contact Lens , Ltd.
Moshav Manof
20184 Misgav,  IL 20184
Correspondent Contact Kevin Walls
Regulation Number886.5925
Classification Product Code
LPL  
Date Received05/24/2002
Decision Date 08/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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