Valleylab LS10 Generator

Electrosurgical, Cutting & Coagulation & Accessories

COVIDIEN LLC

The following data is part of a premarket notification filed by Covidien Llc with the FDA for Valleylab Ls10 Generator.

Pre-market Notification Details

Device IDK143654
510k NumberK143654
Device Name:Valleylab LS10 Generator
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant COVIDIEN LLC 15 HAMPSHIRE STREET Mansfield,  MA  02048
ContactDonald Henton
CorrespondentDonald Henton
COVIDIEN LLC 5920 LONGBOW DRIVE Boulder,  CO  80301
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-23
Decision Date2015-04-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884521780583 K143654 000
10884521512801 K143654 000

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