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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmic Femtosecond Laser
510(k) Number K170322
Device Name Catalys Precision Laser System
Applicant
Abbott Medical Optics, Inc.
510 Cottonwood Dr.
Milpitas,  CA  95035
Applicant Contact Audrey Munnerlyn
Correspondent
Abbott Medical Optics, Inc.
510 Cottonwood Dr.
Milpitas,  CA  95035
Correspondent Contact Audrey Munnerlyn
Regulation Number886.4390
Classification Product Code
OOE  
Date Received02/01/2017
Decision Date 05/19/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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