BiZact Open Sealer/Divider

Electrosurgical, Cutting & Coagulation & Accessories

COVIDIEN

The following data is part of a premarket notification filed by Covidien with the FDA for Bizact Open Sealer/divider.

Pre-market Notification Details

Device IDK160539
510k NumberK160539
Device Name:BiZact Open Sealer/Divider
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant COVIDIEN 5920 LONGBOW DR. Boulder,  CO  80301
ContactSharon Mcdermott
CorrespondentSharon Mcdermott
COVIDIEN 5920 LONGBOW DR. Boulder,  CO  80301
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-26
Decision Date2016-06-15
Summary:summary

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