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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Phacofragmentation
510(k) Number K111697
Device Name AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM
Applicant
Abbott Medical Optics, Inc.
1700 E. St. Andrew Pl.
Santa Ana,  CA  92705
Applicant Contact OPHELIA BIGGS
Correspondent
Abbott Medical Optics, Inc.
1700 E. St. Andrew Pl.
Santa Ana,  CA  92705
Correspondent Contact OPHELIA BIGGS
Regulation Number886.4670
Classification Product Code
HQC  
Date Received06/17/2011
Decision Date 09/27/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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