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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Guide, Intraocular
510(k) Number K072985
Device Name DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2
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
KYB  
Date Received10/23/2007
Decision Date 06/20/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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