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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 K151636
Device Name AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control
Applicant
ABBOTT MEDICAL OPTICS INC
1700 EAST ST. ANDREW PLACE
SANTA ANA,  CA  92705
Applicant Contact Christine Chun
Correspondent
ABBOTT MEDICAL OPTICS INC
1700 EAST ST. ANDREW PLACE
SANTA ANA,  CA  92705
Correspondent Contact Christine Chun
Regulation Number886.4670
Classification Product Code
HQC  
Date Received06/17/2015
Decision Date 10/19/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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