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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 K063155
Device Name MONARCH III IOL DELIVERY SYSTEM
Applicant
Alcon Manufacturing, Ltd.
6201 S. Freeway
Fort Worth,  TX  76134 -2099
Applicant Contact CATHERINE G GOBLE
Correspondent
Alcon Manufacturing, Ltd.
6201 S. Freeway
Fort Worth,  TX  76134 -2099
Correspondent Contact CATHERINE G GOBLE
Regulation Number886.4300
Classification Product Code
KYB  
Date Received10/17/2006
Decision Date 03/27/2007
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
Recalls CDRH Recalls
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