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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 K203060
Device Name VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control
Applicant
Johnson & Johnson Surgical Vision, Inc.
1700 East St. Andrew Place
Santa Ana,  CA  92705
Applicant Contact Amanda Houston
Correspondent
Johnson & Johnson Surgical Vision, Inc.
1700 East St. Andrew Place
Santa Ana,  CA  92705
Correspondent Contact Amanda Houston
Regulation Number886.4670
Classification Product Code
HQC  
Date Received10/08/2020
Decision Date 03/12/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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