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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Soft Lens Products
510(k) Number K030278
Device Name SAUFLON MULTIPURPOSE SOLUTION - NO RUB
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 Number886.5928
Classification Product Code
LPN  
Date Received01/27/2003
Decision Date 07/30/2003
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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