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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 K151783
Device Name COMPACT INTUITIV Multiple-Use Pack
Applicant
Abbott Medical Optics, Inc.
1700 E. St.. Andrew Place
Santa Ana,  CA  92705
Applicant Contact Priya Viswanathan
Correspondent
Abbott Medical Optics, Inc.
1700 E. St.. Andrew Place
Santa Ana,  CA  92705
Correspondent Contact Priya Viswanathan
Regulation Number886.4670
Classification Product Code
HQC  
Date Received07/01/2015
Decision Date 09/02/2015
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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