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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 K111882
Device Name LAMINAR FLOW PHACO TIPS
Applicant
ABBOTT MEDICAL OPTICS INC
1700 EAST SAINT ANDREW PL
SANTA ANA,  CA  92705
Applicant Contact ROSANNE M YETEMIAN
Correspondent
ABBOTT MEDICAL OPTICS INC
1700 EAST SAINT ANDREW PL
SANTA ANA,  CA  92705
Correspondent Contact ROSANNE M YETEMIAN
Regulation Number886.4670
Classification Product Code
HQC  
Date Received07/01/2011
Decision Date 11/07/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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