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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 K052651
Device Name C-FLEX SYSTEM SINGLE USE DISPOSABLE INJECTOR, MODEL R-INJ-02
Applicant
Rayner Surgical, Inc.
Sackville Rd.
Hove, East Sussex,  GB BN3 6WQ
Applicant Contact MARK MULLANEY
Correspondent
Rayner Surgical, Inc.
Sackville Rd.
Hove, East Sussex,  GB BN3 6WQ
Correspondent Contact MARK MULLANEY
Regulation Number886.4300
Classification Product Code
MSS  
Subsequent Product Code
HOY  
Date Received09/26/2005
Decision Date 01/19/2006
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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