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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 K063694
Device Name AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28
Applicant
Bausch & Lomb, Inc.
180 Via Verde Dr.
San Dimas,  CA  91773
Applicant Contact NANETTE CANEPA
Correspondent
Bausch & Lomb, Inc.
180 Via Verde Dr.
San Dimas,  CA  91773
Correspondent Contact NANETTE CANEPA
Regulation Number886.4300
Classification Product Code
KYB  
Date Received12/13/2006
Decision Date 03/07/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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