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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 K132002
Device Name SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR
Applicant
Rayner Intraocular Lenses , Ltd.
1-2 Sackville Rd.
Hove, East Sussex,  GB BN3 7AN
Applicant Contact JULIETTE E COOK
Correspondent
Bsi Healthcare
Kitemark Court, Davy Ave.
Knowlhill
Milton Keynes,  GB MK5 8PP
Regulation Number886.4300
Classification Product Code
MSS  
Date Received07/01/2013
Decision Date 03/27/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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