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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 K052832
Device Name SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENSES
Applicant
SAUFLON PHARMACEUTICALS, LTD.
49-53 YORK ST.
TWICKENHAM, MIDDLESEX,  GB TW1-3LP
Applicant Contact TANYA FAIR
Correspondent
SAUFLON PHARMACEUTICALS, LTD.
49-53 YORK ST.
TWICKENHAM, MIDDLESEX,  GB TW1-3LP
Correspondent Contact TANYA FAIR
Regulation Number886.5925
Classification Product Code
MVN  
Subsequent Product Code
LPL  
Date Received10/06/2005
Decision Date 05/15/2006
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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