SONICISION CORDLESS ULTRASONIC DISSECTOR

Instrument, Ultrasonic Surgical

COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H

The following data is part of a premarket notification filed by Covidien, Formerly Valleylab, A Division Of Tyco H with the FDA for Sonicision Cordless Ultrasonic Dissector.

Pre-market Notification Details

Device IDK141371
510k NumberK141371
Device Name:SONICISION CORDLESS ULTRASONIC DISSECTOR
ClassificationInstrument, Ultrasonic Surgical
Applicant COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H 5920 Longbow Dr Boulder,  CO  80301
ContactDavid Horton
CorrespondentDavid Horton
COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H 5920 Longbow Dr Boulder,  CO  80301
Product CodeLFL  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-05-27
Decision Date2014-08-07
Summary:summary

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