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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 K131958
Device Name BAUSCH & LOMB INJECTOR SYSTEM
Applicant
Bausch & Lomb
30 Enterprise Suite 450
Alusi Vuejo,  CA  92656
Applicant Contact JASON SMITH
Correspondent
Bausch & Lomb
30 Enterprise Suite 450
Alusi Vuejo,  CA  92656
Correspondent Contact JASON SMITH
Regulation Number886.4300
Classification Product Code
MSS  
Date Received06/27/2013
Decision Date 01/09/2014
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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