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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 K081455
Device Name RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06
Applicant
Rayner Surgical, Inc.
Sackville Rd.
Hove, East Sussex,  GB BN3 7AN
Applicant Contact ANDREW WELLS
Correspondent
Rayner Surgical, Inc.
Sackville Rd.
Hove, East Sussex,  GB BN3 7AN
Correspondent Contact ANDREW WELLS
Regulation Number886.4300
Classification Product Code
MSS  
Date Received05/23/2008
Decision Date 09/05/2008
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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