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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Contact, (Disposable)
510(k) Number K130331
Device Name SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER
Applicant
Sauflon Pharmaceuticals, Ltd.
49-53 York St.
Twickenham, Middlesex,  GB TW1-3LP
Applicant Contact CHRISTOPHER SMEJKAL
Correspondent
Sauflon Pharmaceuticals, Ltd.
49-53 York St.
Twickenham, Middlesex,  GB TW1-3LP
Correspondent Contact CHRISTOPHER SMEJKAL
Regulation Number886.5925
Classification Product Code
MVN  
Subsequent Product Code
LPL  
Date Received02/11/2013
Decision Date 07/26/2013
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
Recalls CDRH Recalls
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