COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal

Unit, Phacofragmentation

Johnson & Johnson Surgical Vision, Inc.

The following data is part of a premarket notification filed by Johnson & Johnson Surgical Vision, Inc. with the FDA for Compact Intuitiv System, Compact Intuitiv Wireless Remote Control, Compact Intuitiv Four-button Foot Pedal, Compact Intuitiv Closed-toe Foot Pedal.

Pre-market Notification Details

Device IDK191933
510k NumberK191933
Device Name:COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal
ClassificationUnit, Phacofragmentation
Applicant Johnson & Johnson Surgical Vision, Inc. 1700 East Saint Andrew Place Santa Ana,  CA  92705
ContactLarry Boucher
CorrespondentLarry Boucher
Johnson & Johnson Surgical Vision, Inc. 1700 East Saint Andrew Place Santa Ana,  CA  92705
Product CodeHQC  
CFR Regulation Number886.4670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-19
Decision Date2019-08-16

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