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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 K103023
Device Name UNIT, PHACOFRAGMENTATION
Applicant
Abbott Medical Optics, Inc.
1700 E. St. Andrew Pl.
Santa Ana,  CA  92705
Applicant Contact Evelyn De La Vega
Correspondent
Abbott Medical Optics, Inc.
1700 E. St. Andrew Pl.
Santa Ana,  CA  92705
Correspondent Contact Evelyn De La Vega
Regulation Number886.4670
Classification Product Code
HQC  
Date Received10/12/2010
Decision Date 06/01/2011
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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