LUGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER

Electrosurgical, Cutting & Coagulation & Accessories

COVIDIEN, FORMERLY VALLEYLAB,

The following data is part of a premarket notification filed by Covidien, Formerly Valleylab, with the FDA for Lugasure Curved, Small Jaw, Open Sealer/divider.

Pre-market Notification Details

Device IDK102470
510k NumberK102470
Device Name:LUGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant COVIDIEN, FORMERLY VALLEYLAB, 5920 LONGBOW DRIVE Boulder,  CO  80301
ContactDavid M Horton
CorrespondentDavid M Horton
COVIDIEN, FORMERLY VALLEYLAB, 5920 LONGBOW DRIVE Boulder,  CO  80301
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-08-30
Decision Date2011-02-07
Summary:summary

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