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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 K030910
Device Name CLUED UP MULTIPURPOSE SOLUTION- NO RUB
Applicant
Clued UP Limited
135 High St.
Egham, Surrey,  GB TW20 9HL
Applicant Contact JENNY KOKSHUN
Correspondent
Clued UP Limited
135 High St.
Egham, Surrey,  GB TW20 9HL
Correspondent Contact JENNY KOKSHUN
Regulation Number886.5928
Classification Product Code
LPN  
Date Received03/24/2003
Decision Date 10/10/2003
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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