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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 K121721
Device Name LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)
Original Applicant
ABBOTT MEDICAL OPTICS INC
1700 e. st. andrew place
santa ana,  CA  92705
Original Contact abbas m bohra
Regulation Number886.4670
Classification Product Code
HQC  
Date Received06/12/2012
Decision Date 10/15/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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