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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
Recalls CDRH Recalls
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