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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 K191933
Device Name COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal
Applicant
Johnson & Johnson Surgical Vision, Inc.
1700 East Saint Andrew Place
santa ana,  CA  92705
Applicant Contact larry boucher
Correspondent
Johnson & Johnson Surgical Vision, Inc.
1700 East Saint Andrew Place
santa ana,  CA  92705
Correspondent Contact larry boucher
Regulation Number886.4670
Classification Product Code
HQC  
Date Received07/19/2019
Decision Date 08/16/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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