Sonicision Cordless Ultrasonic Dissector

Instrument, Ultrasonic Surgical

Covidien, Llc

The following data is part of a premarket notification filed by Covidien, Llc with the FDA for Sonicision Cordless Ultrasonic Dissector.

Pre-market Notification Details

Device IDK200427
510k NumberK200427
Device Name:Sonicision Cordless Ultrasonic Dissector
ClassificationInstrument, Ultrasonic Surgical
Applicant Covidien, Llc 5920 Longbow Dr. Boulder,  CO  80301
ContactCelso Duran
CorrespondentCelso Duran
Covidien, Llc 5920 Longbow Dr. Boulder,  CO  80301
Product CodeLFL  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-21
Decision Date2020-07-10

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