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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 E. Saint Andrew Pl.
Santa Ana,  CA  92705
Applicant Contact Larry Boucher
Correspondent
Johnson & Johnson Surgical Vision, Inc.
1700 E. Saint Andrew Pl.
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
Predetermined Change
Control Plan Authorized		 No
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