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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Folders And Injectors, Intraocular Lens (Iol)
510(k) Number K060995
Device Name DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, MODEL DK7788
Applicant
Duckworth & Kent, Ltd.
7 Marquis Business Centre
Royston Rd.
Baldock, Hertfordshire,  GB SG7 6XL
Applicant Contact MARTIN LOCK
Correspondent
Duckworth & Kent, Ltd.
7 Marquis Business Centre
Royston Rd.
Baldock, Hertfordshire,  GB SG7 6XL
Correspondent Contact MARTIN LOCK
Regulation Number886.4300
Classification Product Code
MSS  
Date Received04/11/2006
Decision Date 05/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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