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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 K013649
Device Name SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS
Applicant
Sauflon Pharmaceuticals, Ltd.
49-53 York St.
Twickenham, Middlesex,  GB TW1-3LP
Applicant Contact LIGIA DELACRUZ
Correspondent
Sauflon Pharmaceuticals, Ltd.
49-53 York St.
Twickenham, Middlesex,  GB TW1-3LP
Correspondent Contact LIGIA DELACRUZ
Regulation Number886.5925
Classification Product Code
LPL  
Date Received11/05/2001
Decision Date 12/26/2001
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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