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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 K090806
Device Name SAFI-GEL DAILY DISPOSABLE (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, SAFI-GEL DAILY DISPOSABLE TORIC ( METHAFILCON
Applicant
Safilens, S.R.L.
203 N.Wabash, Suite 1200
Chicago,  IL  60601
Applicant Contact JOHN M SZABOCSIK
Correspondent
Safilens, S.R.L.
203 N.Wabash, Suite 1200
Chicago,  IL  60601
Correspondent Contact JOHN M SZABOCSIK
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received03/25/2009
Decision Date 12/18/2009
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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