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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 K024072
Device Name DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM
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 Received12/10/2002
Decision Date 10/06/2003
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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