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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 K101774
Device Name MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4)
Applicant
Alcon Manufacturing, Ltd.
6201 S. Fwy.
Fort Worth,  TX  76134
Applicant Contact Catherine Goble
Correspondent
Alcon Manufacturing, Ltd.
6201 S. Fwy.
Fort Worth,  TX  76134
Correspondent Contact Catherine Goble
Regulation Number886.4300
Classification Product Code
MSS  
Date Received06/24/2010
Decision Date 10/13/2011
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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