CUSA Clarity Ultrasonic Surgical Aspirator System

Instrument, Ultrasonic Surgical

Integra LifeSciences Corporation

The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Cusa Clarity Ultrasonic Surgical Aspirator System.

Pre-market Notification Details

Device IDK221763
510k NumberK221763
Device Name:CUSA Clarity Ultrasonic Surgical Aspirator System
ClassificationInstrument, Ultrasonic Surgical
Applicant Integra LifeSciences Corporation 1100 Campus Rd Princeton,  NJ  08540
ContactAlexandra Wells
CorrespondentAlexandra Wells
Integra LifeSciences Corporation 1100 Campus Rd Princeton,  NJ  08540
Product CodeLFL  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-17
Decision Date2022-07-15

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